Real Questions and latest syllabus of IIA-CIA-Part2 exam

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Exam Code: IIA-CIA-Part2 Practice exam 2022 by Killexams.com team
Certified Internal Auditor - Part 2, Conducting the Internal Audit Engagement
IIA Conducting course outline
Killexams : IIA Conducting course outline - BingNews https://killexams.com/pass4sure/exam-detail/IIA-CIA-Part2 Search results Killexams : IIA Conducting course outline - BingNews https://killexams.com/pass4sure/exam-detail/IIA-CIA-Part2 https://killexams.com/exam_list/IIA Killexams : Pre-Approved Courses for Advanced Training

Successful completion of one of the following pre-approved courses or workshops will satisfy the advanced RCR training requirement for graduate students studying on campus toward a MS report/thesis or PhD.  Because several of these courses are taught on demand, students are encouraged to contact the instructor when they are planning their study curriculum to ensure the course will be offered during the semester they plan to take it.

CM5621—Research Essentials

For additional information about this course, please contact: Dr. Rebecca Ong or Dr. Timothy Eisele

This course is intended to Improve skills necessary for planning, conducting, analyzing, and presenting research; ethical and responsible conduct, critical evaluation of existing literature, written and oral communication, and experimental design and analysis.


BL5025—The Scientific Profession

( 2 credits)
Instructor: Dr. Amy Marcarelli
Offered in spring. Contact the instructor for more information.

The practice of sciences for graduate students, including how to plan a research project, grantsmanship, publication, navigating the job market, and timely issues (e.g. ethical conduct, diversity and bias, etc.).


FW5811/UN5001—Advanced Responsible Conduct of Research in Natural Resources 

(1 credit)
Instructor: Dr. Andrew Storer
Offered on demand in the summer. Contact the instructor for more information.

This three-day course offered between spring and summer semester will offer training in advanced RCR topics. The class will draw on examples relating to natural resources where possible, but is open to all students.


HU5711/EH5711—Bioethics

(3 credits)

For additional information about this course contact the Humanities Department

Examination of key bioethical issues, with an emphasis on problems in biomedical research ethics, novel therapies and developing technologies.  Topics include disability, quality of life, research with vulnerable populations, research on animals, genetics technologies, and biomedical enhancement.


MEEM 5010—Professional Engineering Communication

(3 credits)
Instructor: Dr. Nancy Barr
Offered in fall. Contact the instructor for more information.

This course will introduce graduate students to t he conventions of professional engineering communication such as composing technical memos and a variety of reports (test, design, progress , etc.).  Students will learn and practice creating effective visuals for reports and slides and also develop and deliver presentations individually and in groups. Students will also learn and apply ethical decision-making and critical t hi n king skills.  The course is designed for students interested i n a career i n applied engineering and management.


MEEM 6010—Engineering Research Communication

(2 credits)
Instructor: Dr. Nancy Barr
Offered in spring. Contact the instructor for more information.

This course will guide graduate students through the process of conducting and publishing research in an ethical manner in technical journals and presenting that research at conferences and other venues. Students will receive regular, relevant feedback on their writing and presentation skills and will be expected to provide constructive feedback to their colleagues in the course. The course helps graduate students in engineering with their research-specific communication tasks. Students will work one-on-one with the instructor to complete a journal article, conference paper, proposal, etc., make progress on their dissertation, or other agreed- upon projects. Students will also learn the standard components of advanced writing tasks, including abstracts, literature reviews, CVs, proposals, critiques, and more. Also, students will deliver a complete scientific presentation with visual aids in a research colloquium format.


PSY 5020—Research Methods

(3 credits)
Instructor: Dr. Kelly Steelman
Offered on demand in the fall.  Contact the instructor for more information.

This course provides a foundation in research methods in cognitive science and human factors, with an emphasis on experimental design, research ethics, and scientific communication. This course meets Michigan Tech’s Advanced Responsible Conduct of Research (RCR) requirements through its coverage of scientific misconduct, ethical standards of the discipline, RCR violations and sanctions, responsible publication and authorship practices, the peer review process, conflict of interest, societal expectations, and discipline-specific coverage of human-subject research.


SS6002—Research Design

(3 credits)
Instructor: Chelsea Schelly
Offered in the spring. Contact the instructor for more information.

This course is a general overview of issues on conducting social science research. Rather than provide students with in-depth knowledge of any particular method, this seminar  will be the first step for graduate students in developing their professional and methodological knowledge about the trade-offs of various methods of data collection, the strengths and weakness of different types of analysis, and the components of rigorous research design generally. This course is meant to introduce you to the diversity of thought and approaches to social science research; it is not meant to be specialized training course preparing you with the skills and experience to master a particular method.


SS4211 – Ethnographic Methods

(3 credits)
Instructor: Rotates
Offered in spring. 

Contact the Social Sciences Department for more information. This seminar introduces ethnographic theory and methods. Course materials and discussions will include a survey of ethnographic methods such as interviews, participant observation, and other methods, and how these methods generate different knowledges. You will be introduced to techniques for collecting, coding, analyzing, and sharing qualitative data. Throughout the course, you will learn conventions and concerns of designing an ethnographic study, including developing a research question, completing human subjects protocols, and ethnographic analysis and writing. This course fulfills MTU’s advanced RCR training requirement.


UN0500—Effective Scholarship

(1 credit)
Instructor: Dr. David Dixon 
Offered on demand in fall and spring.

Meets during the first five weeks of the semester for two hours per week. This course may be taken as an overload in candidacy mode with no approval needed. Although this course satisfies the advanced RCR requirement, students may not count it towards their required credits to complete their degree. No tuition charged, but students are charged a lab fee.

Course meets federal requirements for responsible conduct of research training for graduate student.  Students who pass the course will be awarded a certificate of completion.  This class may not be counted toward the required credits to complete a degree (i.e., may not be listed on a graduate degree schedule).


UN5500—Research Integrity Workshop

 (1 credit)
Instructor: Dr. Mike Bowler
Offered on demand in summer. Contact the instructor for more information.

Three 4-hour workshops introduce students to the principles, practices, and regulations of responsible conduct of research.

Wed, 21 Oct 2020 02:15:00 -0500 en text/html https://www.mtu.edu/research/integrity/responsible-conduct/training/courses/
Killexams : Course offerings and outlines

Fall 2022 (1227) term

Course units: 100, 200, and 300 levels: 3 units each; 400 level: 4 units each. 

REPEATS: the following courses can be repeated for additional credit provided that the subject is different: PHIL 131, 302, 314, 321, 326, 331, 332, 333, 342, 343, 344, 346, 357, 421W, 435, 451W, 455W, 467W. Any of the other PHIL courses, when taken a second time, will be considered a repeat, even if the subject is different from a previous offering. 

Elective grade policy : P/CR/NC. In place from Spring 2021 to Summer 2023. See List of exclusions for the elective grade policy. Specifically for Philosophy: 

  • Students can use a P or CR to satisfy any requirement for a major, joint major, honours, or minor in Philosophy (exception: PHIL 477 and 478).
  • Students can use a P or CR to satisfy any prerequisite requirement for any PHIL course.
  • Students can use a P (but not a CR) to satisfy any requirement for the Ethics Certificate, or the Philosophy and Methodology of Science Certificate.
  • Philosophy Majors and Honours students can use a P (but not a CR) to satisfy any WQB requirement.

Philosophy Courses with Writing, Quantitative or Breadth designations:

PHIL 100W (Knowledge and Reality) W/B-Hum  
PHIL 105 (Critical Thinking) - formerly PHIL XX1 Q/B-Soc/Sci  
PHIL 110 (Introduction to Logic and Reasoning) Q  
PHIL 120W (Moral Problems) W/B-Hum  
PHIL 121 (Global Justice) B-Hum/Soc  
PHIL 131 (Selected Topics) B-Hum  
PHIL 144 (Introduction to Philosophy of Science) B-Hum/Sci  
PHIL 150 (Great Works in the History of Philosophy) B-Hum  
PHIL 300 (Introduction to Philosophy) B-Hum  
PHIL 310 (Logic, Proofs and Set Theory) Q
 
PHIL 345W, 421W, 451W, 455W, 467W W  

Upper Division Electives

If you are looking for upper division courses outside of Philosophy, click here for an updated list of electives with the Faculty of Arts and Social Sciences. 

Breadth Courses

If you are a Philosophy Major, you will also need Breadth courses from OUTSIDE of Philosophy. You can find a full list of Breadth designated courses here. Search gosfu for current offerings.   

Sun, 20 Dec 2015 07:16:00 -0600 text/html https://www.sfu.ca/philosophy/courses/courses_current.html
Killexams : CHEM.2280L Organic Chemistry Laboratory IIA (Formerly 84.228)
Id: 007662 Credits Min: 2 Credits Max: 2

Description

A continuation of 84.227 including an introduction to semimicro organic techniques. Planning and successfully carrying out reactions published in the chemical literature are emphasized. Required for chemistry majors.

Prerequisites

Pre-reqs: CHEM 2210 Organic Chemistry IA, CHEM 2270L Organic Chemistry Lab II; Co-reqs: CHEM 2220 Organic Chemistry IIA, CHEM 2600 Info Retrieval. For Chemistry Majors Only.

View Current Offerings
Wed, 13 Apr 2016 09:56:00 -0500 en text/html https://www.uml.edu/catalog/courses/CHEM/2280L
Killexams : CytoDyn: Repositioning And Refocusing With New Leadership
Technician at a laboratory surrounded by lab tools

LL28

CytoDyn Inc. (OTCQB:CYDY) is a Vancouver, WA-based small cap research and development biotechnology business with a focus on the clinical development of therapeutic treatments for multiple indications. According to Stock Market MBA, it is listed as a penny stock and trades on the OTCQB under the ticker symbol (OTCQB:CYDY).

As of October 14, 2022, its share price was .44 cents, average traded volume was 1.13M shares and it has a market cap of $357.6M. The 52W high is $1.85 and the 52W low is $.2311.

Current Enterprise Value (EV) of CYDY is $401M. EV is calculated by adding the current market cap with the debt and backing out the cash and immediate cash investments. MC+Debt-Cash=EV

CYDY is amongst several stocks I have designated in my "High Risk, High Reward" Biotech Portfolio. Other stocks in this portfolio include Inovio Pharmaceuticals (INO), Agenus, Inc. (AGEN), Alpine Immune Sciences (ALPN), Crinetics Pharmaceuticals (CRNX), Relay Therapeutics (RLAY), Xenon Pharmaceuticals (XENE) and X4 Pharmaceuticals (XFOR).

I'm long in each of these based on a combination of their stories, their potential/probability of success, management execution, near term catalysts in the pipeline, a molecule's clinical benefits and my own personal degree of risk tolerance.

Chart
Data by YCharts

Introduction

Today, I'll explore the measures CytoDyn has taken to conduct an assessment of their business and outline the reasons why these steps are crucial in order for me to maintain my position in (OTCQB:CYDY).

CytoDyn remains within my non-revenue generating, high-risk high-reward biotech investment portfolio. In addition to CYDY being a non-revenue generating biotech investment, the company has been mired down with more than just your 'garden variety' biotech threats that most biotech management teams can usually resolve. My definition of garden variety biotech threats has evolved after a decade-plus years of investing in the biotechnology industry. These concerns, taken alone don't usually spell disaster for most equities, but several in succession or in combination, may end in losses for investors.

Non-revenue biotechnology companies are particularly more vulnerable as they're more sensitive to a number of broad threats that impact their financial stability. These threat vulnerabilities include strict regulatory oversight and scrutiny, legal entanglements, patent infringement claims, fluctuations in cash burn rates, competing clinical interests by numerous companies, changing multiples based on pipeline candidate success/failure, the lack of leverage or influence with potential suitors, the accumulation of losses that lead to increased debt, potential mismanagement and finally, bankruptcy.

The present case with CYDY; Management mistrust by investors, intense scrutiny by the SEC and DOJ, applications and filings rejected by the FDA, clinical holds, hostile takeover events initiated, continued arbitration, loss of capital, increased debt, insolvency a looming concern and valuable research time lost, never to be recovered place CYDY in a precarious situation.

So, why do I stay invested in CytoDyn? New leadership brings new strategic initiatives, the commitment to resolve issues, rebuild relationships, reshape the organization, as well as the exact shareholder approval of 350M shares to the float and finally the #1 reason why I stay invested in CYDY...the clinical safety and effectiveness of Leronlimab.

Future Development Strategy

Changes in Leadership

CYDY

Leadership (CytoDyn)

"What got us here today is not what will lead us into the future." - Cyrus Arman, Board President - CYDY

Before I supply my thoughts on Cyrus Arman, Ph.D., MBA and as other investors have asked in social media platforms, why did Dr. Arman choose to serve at CytoDyn with so many concerns, discussed above? Well, that question was recently answered in a webcast during a quarterly investor update.

The decision to come to CYDY was based on what he describes as his "prior experiences in the biotech industry" which have allowed him to look under the hood at hundreds and hundreds of different molecules, either from the perspective as a developer, competitor, investor or acquirer. Those diverse industry perspectives, coupled with his management background, education and industry knowledge has helped him identify what he described as the "hallmarks" to getting a clinical stage therapeutic to market.

Subsequently, after his close examination of the data on the therapeutic benefits of Leronlimab, he has concluded that Leronlimab is a "unique" therapeutic which has a clinical benefit to patients and the potential for a return to investors.

A clue as to how Dr. Arman and his efforts have been welcomed so far. This from Dr. Scott Kelly (OTCQB:CYDY) in the same webcast,

When we first began our search for a new CEO, the Board of Directors of CYDY was focused on finding a unique individual with experience in corporate strategy and development, capital markets, licensing agreements, corporate governance with a firm scientific background and the ability to be a strategic thinker. We needed someone who would not only understand the potential opportunity of Leronlimab but, would execute on this opportunity. We believe we have found that person in Dr. Arman...He has chosen Leronlimab after much due diligence. We believe Leronlimab is now in the best of hands.

One of the things that Dr. Arman and I agree with wholeheartedly is to focus and surround ourselves with the people that we believe will make Leronlimab a success with our current focus and initiatives. Under the leadership of Dr. Arman, I can tell you we believe our team has never been stronger and the work we are currently doing is placing CYDY and Leronlimab on the best possible path for success.

Also discussed in the webcast was their strategic assessment of the pipeline to determine which indications are high value opportunities and which indications are being tucked away. To do this, the Net Present Value was utilized.

Net Present Value Model

The Net Present Valuation model is a decision support tool that allows CYDY to decide whether it's worth to take up an indication that can generate a positive return. It is a method used to determine the Net Present Value (NPV), considers the Discounted Cash Flows (DCF), by taking the 'time value of money' into account and translating all Future Cash Flows (FCF) into today's money and adding up "today's investment" with the present value of all future cash flows. By modeling these flows of money including interest rates, taxes, the weighted cost of capital (WACC) and more over a specified period of years we can calculate if the project is worth pursuing. An NPV greater than zero >0 is worth pursuing and an NPV that is calculated to be less than <0 is not worth pursuing.

This assessment, from what we learned in the webcast, was the basis for the decision making to let go of the line of COVID therapeutics and to finally leave no doubt to CytoDyn's strategic path going forward.

Dr. Arman also provided some insight on how the rest of the bullpen will look with a focus on Colorectal Cancer (CRC), in particular the metastatic multi-satellite stable (MSS) population as this group accounts for the largest percentage of CRC patients. While achievements using multi-disciplinary approaches to treating CRC have improved the patient OS rates, there is still plenty of room for improvement and CRC remains one of the greatest unmet needs in oncology. Additionally, hormone receptor positive (HR+) and HER2 positive breast cancer are in focus. Clearly, CYDY is targeting solid tumor cancers utilizing Leronlimab based on its method of action in the micro-tumor environment and safety profile.

The strategic assessment to freeze operations in order to refocus and retool the pipeline, trim the wasteful spending, recognize the external threats to former clinical efforts and focus on the higher value opportunities as the main driver that serves to steer all future efforts, helped me make my decision to remain invested in this small high risk-high reward biotech company.

BLA Update

CYDY

Google

As outlined, the company performed a strategic review and assessment of their entire pipeline after the FDA placed a partial clinical hold on its rolling submission BLA for the HIV Multi-Drug Resistant population, as well as a full clinical hold on its Covid-19 trials until CYDY could address FDA concerns that involve a dispute with their previous Contract Research Organization (CRO), Amarex.

In dispute are concerns that the data collected by Amarex was improperly coded and not in accordance to current industry standard format. According to CEO Arman at 12:30 minutes in this webcast,

"It's important to note that substantially, all of the data requested by the FDA to lift the clinical hold are items that Amarex was contracted by CYDY to prepare but, failed to do so."

As a result, an external audit by a high quality independent research company has been retained by CYDY in order to audit the quality of the data collected and monitoring performed by Amarex. Once this audit is complete, CYDY can determine the feasibility of submitting the data, but only after making the determination that there is a high "probability" it could pass an FDA Good Clinical Practices audit, as part of the BLA submission. The results of the audit will determine the next steps with the BLA.

While certainty regarding the outcome of the audit remains in question, the steps taken by management are relevant to the overall strategic planning process and the future development strategy. The NPV exercise identified HIV as a high value opportunity and more details will be forthcoming after the audit.

Shareholder Approval

On August 31, 2022, the Company held a special meeting of stockholders. The meeting was held to seek shareholder approval to increase the total number of authorized shares of common stock of CYDY from 1M to 1.35M shares. The proposal was approved so, what's next?

The company has a number of options they can exercise in order to maximize the benefit of the additional shares. While they could immediately begin to sell shares at the market, the current share price would only provide ~$140M in cash. However, an announcement of more positive details surrounding the Amarex data and more clarity on the submission of the rolling BLA and/or communication of positive response from the FDA could serve as a short term catalyst to move the share price into higher territory, at which time even touching the exact high of $1.26 could add as much as 3X the amount of cash or ~$420M. In fact, if the share price can break through several areas of resistance before getting to $1.26, it may not be necessary to dilute the full amount and CYDY can hold back shares to sell later at a much higher premium.

Furthermore, adding cash to the balance sheet can certainly attract a partner who may be willing to risk some of their own R&D capital since CYDY can take on the higher additional financial obligation. Other options include structuring Loan Facility Agreements with the options to add cash in tranches and interest only payments over a specified period of time at variable rates.

These scenarios, I believe, fits into the overall playbook in the future development strategy currently underway at CYDY.

Leronlimab

CYDY

CCR 5 (Seeking Alpha)

CytoDyn's lead product candidate Leronlimab, is a humanized monoclonal antibody that targets the CCR5 receptor. The CCR5 receptor is believed to be involved in immune-mediated inflammation such as HIV and other indications such as cancer, autoimmune diseases, other inflammatory diseases, infectious diseases and more.

HIV naturally seeks out the CCR 5 receptor for entry and infection of healthy cells. Leronlimab acts like a sentry at all the entry points of the cells as it binds to the CCR5 receptor on the CD4 cells, thus interfering with HIV's ability to enter the cell. It prevents the virus-cell binding activities at a distinct site on the CCR5 co-receptor without interfering with its other natural activities.

Investors in CYDY are familiar with the benefits of Leronlimab, a humanized monoclonal antibody that has shown an excellent safety profile and clinical benefits in several human clinical trials. The global monoclonal antibodies industry was valued at USD 105.2 Billion in 2020 and is expected to reach USD 155.2 Billion in 2028 growing at a CAGR of 6.7%, fueled by the rise in cancer with North America leading the way as the largest segment in the world.

Non-Alcoholic Steatohepatitis NASH

An Insight Partners May 2022 report forecasts the TAMS for NASH to reach $24.26 billion by 2028 from $1.63 billion in 2021; it is expected to register a CAGR of 47.1% from 2021 to 2028.

Additionally, an article in Science Direct "The Epidemiology of Non-Alcoholic Steatohepatis" adds

Non-Alcoholic Fatty Liver Disease (NAFLD) is characterized histologically into Non-Alcoholic Fatty Liver (NAFL) and Non-Alcoholic Steatohepatitis (NASH). NASH patients are at an increased risk of advanced fibrosis and cirrhosis [1]... In 2017, the lifetime costs of NASH patients in the US were estimated at $222.6 billion, and the cost of the advanced NASH population is estimated at $95.4 billion [4]. The gold standard for the diagnosis of NASH remains a liver biopsy. NASH is defined as the presence of >4% hepatic steatosis and inflammation with hepatocyte injury (ballooning), with or without fibrosis [5]. Some studies have indirectly assessed the prevalence of NASH. The prevalence of NASH among NAFLD patients who underwent a random liver biopsy was 6.67%. The prevalence of NASH among NAFLD patients with a clinical indication for a liver biopsy was 59.10%. Given these estimates, the average prevalence of NASH was estimated to be between 1.5% and 6.45%

If successful treatments for NASH are developed, it will likely come down to the need for several drugs, either as a mono-therapy to treat NASH and/or a combination of therapies that target the disease or those factors contributing to NASH, such as the inflammatory and metabolic characteristics. As such, the task currently at hand is to identify which patients are likely to respond best to which therapies with the possibility of several drugs being granted approval.

For more on NASH, readers can find useful information at the National Institute of Health (NIH) National Institute of Diabetes, Digestive and Kidney Diseases Central Repository NIDDK and LabCorp.

NASH - Research and Development Costs

The first graph below depicts the clinical stage phases II and III, as well as BLA filings and if necessary a PHIV trial of NASH. The R&D expenses, SG&A, COGS, taxes, royalty payments, etc. are a hefty price for NASH until any revenue is projected to realized in 2028 (see below).

According to a 2020 study on the cost of clinical trials, reported to the US Department of Health and Human Services,

The average cost of phase I, II, and III clinical trials across therapeutic areas is around $4, $13, and $20 million respectively. Pivotal (phase 3) studies for new drugs approved by the Food and Drug Administration FDA cost a median of $41,117 per patient. Source: SOFPROMED

Here, upwards of over $127M in costs to fund operations while conducting clinical trials by CYDY is illustrated. As previously noted, the Net Present Value assessment identified NASH as having a positive NPV and the following several illustrations makes their case clear.

Note: Readers should understand these projections are more of an art than an exact science, especially when evaluating the Weighted Average Cost of Capital (WACC) of a small cap biotechnology company, their beta (volatility) and the time needed to execute on objectives.

CYDY

NASH Pre-clinical Trial (SOFPROMED, MGDL Comps, 10-Q)

The graph is an illustration of basic assumptions derived from sources such as the US Census Bureau, ClinicalTrials.gov, science literature, related NASH PHII and PHIII trials with Madrigal Pharmaceuticals, and a 2018 PubMed article, "Estimation of clinical trials success rates and related parameters."

CYDY - NASH Revenue Scenario

The following graphs indicates modeling of NASH revenue from 2028-2034 and with peak market penetration at 25% in 2031 realizing there could be, as discussed in this article, multiple therapies either standalone mono-therapies or combination therapies available.

Note: As described, these figures are in millions, unless otherwise noted.

CYDY

NASH Revenue Projections - CYDY (TAMS Market Data, 10-Qs, Science Literature)

Free Cash Flow Scenario - Post Approval

CYDY

FCF (Model Projections - Eberhart)

Enterprise Value

Imputing the data found throughout the available literature, as well as using Madrigal Pharmaceutical (MDGL) as a comparable for NASH related expenses indicates the potential future enterprise value worth $65.7B with only 25% peak market penetration starting in 2032 and value to the share price of $48.74.

Additionally, the market price of $150K for the treatment is not only a fair estimate, it stays within my thesis that there will likely be various forms of competition in the space and other than efficacy as a deciding factor for prescribers, insurers willing to pay for treatment must be considered when options become available.

CYDY

Enterprise value (Model Projections - Eberhart)

Risks & Headwinds

The discussion of risks has been examined throughout this analysis. However, with penny stock investments, it's prudent to cover additional potential risks. Two risks in particular, the competition in the Non-Alcoholic Steatohepatitis NASH space and the potential risk of reverse stock splits.

Competition

My first analysis of CYDY on August 24, 2022, in Seeking Alpha showcased the results of a very small study (N=72) that discussed the top line results of a small clinical trial and which was first presented at the International Liver Congress 2022. I also reported the Total Addressable Market TAM for NASH. While this was a small multi-center Phase IIa trial, CYDY announced in the August webcast that they're moving ahead after identifying NASH as high value opportunity. While NASH, no doubt is a high value opportunity, it is also very attractive to other biotechnology industry players.

Take for instance Madrigal Pharmaceuticals. Without elaborating on the drugs Method of Action MOA in too much detail, their drug works by increasing the function of thyroid hormone beta receptors without interfering with the thyroid axis hormones. This is critical to in order to deliver the full therapeutic potential of their once daily administered drug.

This from their website,

  • Topline Phase 3 data announced in January 2022, demonstrated resmetirom was safe, well-tolerated and provided statistically significant improvements in key measures of liver and cardiovascular health.
  • Data from the Phase 2 study published in The Lancet, demonstrated that liver fat reduction of ≥30% with resmetirom was associated with NASH resolution and liver fibrosis reduction as measured by liver biopsy. Liver fat was measured by MRI-derived Proton Density Fat Fraction (MRI‐PDFF).
  • Phase 2 results also demonstrated treatment with resmetirom lowered multiple atherogenic lipids and lipoproteins, including LDL-cholesterol, apolipoprotein B, triglycerides and lipoprotein (A) ― a key potential benefit as NASH patients have elevated cardiovascular risk.
  • To date, resmetirom has demonstrated a generally favorable safety and tolerability profile including in Phase 3 studies in which over 2,000 patients have enrolled, with many treated for more than one year.

According to information obtained from the clinicaltrials.org database this pharmaceutical has already initiated two (2) additional PHIII clinical trials with their investigational drug known as MGL3196 or Resmetirom.

One trial has 2000 participants, split into three arms, with a primary endpoint to measure and assess the effectiveness of either their 80mg or 100 mg dose of MGL3196 vs placebo. Additionally, other endpoints include looking at composite long-term outcome measured by the number of patients with the onset of any of the adjudicated events, composed of cirrhosis, all-cause mortality and liver-related clinical outcomes.

Resmetirom is administrated orally and an announcement on the clinical data is expected in the near future as the primary endpoint completion date was in December 2021. MDGL has an earnings call slotted for November and investors on social media platforms believe this could be the month the findings are revealed, based on a prior history of MDGLs leadership team making these sort of catalyst like announcements during past earnings calls. Should positive findings be announced, the share price is undoubtedly set to go parabolic as it will be the first to cross the finish line for this unmet need.

Madrigal is also conducting their second PHIII trial for patients with well-compensated NASH Cirrhosis but, is not expected to be completed until November 2025, with 700 participants.

ClinicalTrials.gov Identifier: NCT05500222

Clinical Trial Funding

Before they can advance to PHIII the need to fund a larger PHII clinical trial is likely and it will have a significant impact on the future development of Leronlimab's full potential.

As MDGL was used a comparison in the revenue building models, their PHII trails for their drug candidate included 700 participants and PHIII trials with 2000. A PHII and PHIII trial, with a much larger population, will result in increased cash burns as more clinical sites will be required, start up and recruitment costs, additional research teams, data management, pass through costs and the inclusion of a Clinical Research Organization CRO as well as the inclusion of appropriate histopathological endpoints will likely become a necessary addition by the FDA.

The cost of trials, according to the website SOFPROMED varies, as shown in the chart below, but has a mean cost of roughly $41,000 per participant.

Clinical Cost

SOFPROMED

Reverse Splits and Stock Dilution

Authorization by shareholders in August gave CytoDyn the potential to increase its overall amount of shares to approximately 1.35B shares. While I highlighted in this article the advantage this approval can have to attract investment opportunities for partners, it may not come to fruition. Regardless, the need to raise cash and erode shareholder value through dilution is all but unavoidable in order to keep the doors open. If you're new to biotech investing, this is an inevitable consequence of biotech companies and typically necessary.

However, shareholders should never stick their head in the sand and ignore the potential of a reverse stock split. There are several reasons why a company may decide to execute a reverse stock split and reduce its number of outstanding shares in the market. As I stated in other articles, this may be done to prevent being delisted, boost the company's image and to draw more attention from analysts and Wall Street investment firms who have minimum share price limits structured into their by-laws which prevent them from owning stocks under certain limits, such as $5.00.

The good news is once a reverse split occurs and if the share price can stay above these limits, many biotech exchange-traded funds ("ETFs") are interested in owning them as part of a broad ETF biotech portfolio. Of course, the downside is the appearance that a company is using some accounting magic to hide their financial problems.

Closing

I believe that CYDY remains attractive at this level and if you're willing to enter the "high-risk high reward arena", CYDY may very well be worthy of your consideration but, only as a small portion of your overall "high-risk, high reward" investment portfolio.

The Net Present Value assessment conducted by the executive team at CYDY has determined that NASH is of utmost importance and is a very high value opportunity. The revenue models prove this assessment to be accurate and worth the execution and discipline it will take from their new leadership.

While Madrigal Pharmaceuticals appears to be closing in on the finish line, there are others also in the space. MDGL is potentially on the horizon of a near term catalyst that could move the SP in a parabolic move. I have no ownership in MDGL.

Clinical trials results are a key ingredient to the process of drug development in the pipeline and the PoS used to estimate biotech valuations. Each approval or failure in a phase can drastically move the share price. Investors can see the binary nature of these trial outcomes due to the many moving parts attributed to the modeling by Wall Street, not to mention the volatility as the models price in the new information.

Finally, building a robust pipeline, establishing partnerships and creating a healthy balance sheet are essential with Wall Street analysts who apply models that project multiples on pre-revenue biotech's.

In conclusion, CytoDyn could earn a place in the NASH market if they can overcome the headwinds and execute on all aspects of the business. Their efforts to refocus and reposition the priorities may just be the cure.

One final note: The only favor I ask is that you click the "Follow" button so I can grow my Seeking Alpha readership. This will help me, to help you. Learning and knowledge is a key to investing. It's already difficult for the casual retail investor to find little nuggets of information behind the backdrop of high speed-high frequency investment houses that collate data and trade in milliseconds. My promise is that I will always do my best to provide you with accurate and timely information, when it is submitted to SA.

Small cap biotechnology investing is only a fraction of my overall investment portfolio which, supported by other investments, has increased my likelihood I'll be able to maintain a comfortable retirement for the years ahead. While I do my best to present factual research, readers should understand the risks before making any investments decisions.

Mon, 17 Oct 2022 01:36:00 -0500 en text/html https://seekingalpha.com/article/4546936-cytodyn-repositioning-and-refocusing-with-new-leadership
Killexams : Art Studio IIA

Course planning information

You need to complete the above course or courses before moving onto this one.

213251

The courses listed above have similar content to this one meaning you can only enrol in this course or one of the listed courses. Only one of the courses can be credited towards your qualification.

General progression requirements

You must complete at least 45 credits from 100-level before enrolling in 200-level courses.

  • 1 Generate a range of ideas for exploration in response to a prescribed project.
  • 2 Explore relationships between concepts, media and processes.
  • 3 Engage in basic self-directed inquiry to develop studio projects.
  • 4 Develop the ability to express critical ideas through class discussion and critiques.
  • 5 Present their studio work in a considered manner.

Learning outcomes can change before the start of the semester you are studying the course in.

Assessments

Assessment weightings can change up to the start of the semester the course is delivered in.

You may need to take more assessments depending on where, how, and when you choose to take this course.

Explanation of assessment types

Computer programmes
Computer animation and screening, design, programming, models and other computer work.
Creative compositions
Animations, films, models, textiles, websites, and other compositions.
Exam College or GRS-based (not centrally scheduled)
An exam scheduled by a college or the Graduate Research School (GRS). The exam could be online, oral, field, practical skills, written exams or another format.
Exam (centrally scheduled)
An exam scheduled by Assessment Services (centrally) – you’ll usually be told when and where the exam is through the student portal.
Oral or performance or presentation
Debates, demonstrations, exhibitions, interviews, oral proposals, role play, speech and other performances or presentations.
Participation
You may be assessed on your participation in activities such as online fora, laboratories, debates, tutorials, exercises, seminars, and so on.
Portfolio
Creative, learning, online, narrative, photographic, written, and other portfolios.
Practical or placement
Field trips, field work, placements, seminars, workshops, voluntary work, and other activities.
Simulation
Technology-based or experience-based simulations.
Test
Laboratory, online, multi-choice, short answer, spoken, and other tests – arranged by the school.
Written assignment
Essays, group or individual projects, proposals, reports, reviews, writing exercises, and other written assignments.
Wed, 28 Sep 2022 19:15:00 -0500 en-NZ text/html https://www.massey.ac.nz/study/courses/art-studio-iia-213241/
Killexams : Qualitative Research to Optimise Design and Conduct of Randomised Trials

This course aims to illustrate how qualitative research can be used to optimise the design and conduct of randomised trials, particularly pragmatic trials of complex interventions.

Introduction

This course will demonstrate how qualitative research can be used to address particular trial design and conduct issues, enhance understanding of how qualitative methods can be integrated at various stages of a trial, show how a range of qualitative methods can be used within trials, and facilitate greater confidence in including qualitative research in grant applications for randomised trials. It is not a course of how to do qualitative research but rather a course on how to appreciate its value within trials.

Course format

This 1 day course will run online using Blackboard Collaborate, with a mix of live presentations and small group work.

Course objectives

By the end of the course participants should:

  1. appreciate how qualitative research can be used to address particular randomised trial design and conduct issues (particularly in pragmatic trials of complex interventions);
  2. be aware how qualitative research can be of value at various stages of the trial process;
  3. realise the range of qualitative methods that can be used within a trial; and
  4. be better equipped to include qualitative research in grant applications for randomised trials.

Who the course is intended for

This course is intended for researchers and health professionals who have a reasonable knowledge of the process of conducting randomised trials within a health service context, and who are interested in how qualitative methods can optimise the design and conduct of a trial; and qualitative researchers who wish to consider how they could apply their skills to optimise the design and conduct of randomised trials.

Course outline

This course will cover:

  1. using qualitative research to address particular randomised trial design and conduct issues;
  2. integrating qualitative research at various stages of the development and running of a trial;
  3. how a range of qualitative methods can be used within a trial; and
  4. incorporating qualitative research in grant applications for randomised trials.
Sun, 22 Aug 2021 00:43:00 -0500 en text/html https://www.bristol.ac.uk/medical-school/study/short-courses/biennial-non-active-courses/qualitative-research-to-optimise-design-and-conduct-of-randomised-trials/
Killexams : Designing and Conducting Pragmatic Randomised Controlled Trials

This course aims to provide an understanding of the essentials of designing, conducting and analysing pragmatic randomised controlled trials (RCTs). The course examines RCTs evaluating health and public health interventions in primary, secondary and community settings with individual and cluster randomised designs. Please note this course does not go into lots of detail about regulatory approvals and research governance.

Course format

This 5-day course will be online, consisting of a mix of live and pre-recorded and practical sessions. Comittment per day approx 50% of that in person.

Course objectives

By the end of the course participants should be able to:

  1. understand why and when randomised trials are optimally conducted; 
  2. address the key questions in designing a trial, including sample size;
  3. examine issues involved in the planning, conducting and completing a successful trial;
  4. understand how to assess patient experiences and incorporate patient and public involvement effectively in trials; 
  5. use strategies to enhance trial recruitment, adherence and retention;
  6. understand the distinctive concepts in the analysis of clinical and health economic data in pragmatic randomised trials; and
  7. gain insight into the experience of being a Chief Investigator and working with registered Clinical Trials Units.

Who the course is intended for

This course is designed for:

  • Trial Managers and co-ordinators
  • Researchers / Administrators working on trials
  • Chief Investigators / Principal Investigators
  • Other specialists looking to understand RCTs including clinicians, health care and public health care researchers

Course outline

This introductory course will cover:

  • need for randomised trials;
  • design of trials;
  • randomisation;
  • sample size;
  • feasibility and pilot studies;
  • trial planning, resourcing and working with the NHS;
  • trial initiation;
  • qualitative research in trials;
  • Patient and Public Involvement;   
  • optimising trial recruitment;
  • trial conduct and closure;
  • protocol adherence and missing data;
  • cluster and public health trials, including in schools;
  • outcome assessment and Patient Reported Outcome Measures;
  • health economics overview;
  • primary and secondary trial analyses;
  • experience of being a Chief Investigator;
  • Clinical Trials Unit support for trialists; and
  • CRF and database design.
Sat, 14 Aug 2021 06:03:00 -0500 en text/html https://www.bristol.ac.uk/medical-school/study/short-courses/2021-22-courses/designing-and-conducting-pragmatic-randomised-controlled-trials/
Killexams : Best Cryptocurrency Trading Courses

Udemy’s Complete Cryptocurrency Investment Course covers all of the fundamentals of cryptocurrency investing in an affordable, self-paced, mobile-friendly format, making it the best overall cryptocurrency trading course on our list.

Originally created as a simple virtual classroom software in 2012, Udemy has since grown to become one of the largest online learning platforms offering over 185,000 courses taught by more than 64,000 instructors in 75 languages. Its Complete Cryptocurrency Investment Course introduces students to the basics of cryptocurrencies and advances them quickly into investing techniques featuring live examples. As a result, it’s our clear choice as the best course overall.  

The Complete Cryptocurrency Investment Course is led by Mohsen Hassan, a programmer, trader, and financial risk manager who has taught investing to more than 300,000 Udemy students. The course consists of over 12.5 hours of on-demand video, one article, and one downloadable resource and can be accessed on the Udemy mobile app.

The Complete Cryptocurrency Investment Course walks beginners through the fundamentals of cryptocurrency and quickly moves to live examples of buying, transferring, and using wallets as well as portfolio management techniques for both passive and active investing. Through this course, Hassan buys, transfers, secures, and builds a portfolio with real money so students can see exactly how it’s done.

The Complete Cryptocurrency Investment Course costs just $84.99 and includes full lifetime access, a certificate of completion at the end of the course, and a 30-day money-back guarantee. Udemy runs specials all the time, so you may be able to purchase the course for a much lower price.

Tue, 16 Feb 2021 04:28:00 -0600 en text/html https://www.investopedia.com/best-cryptocurrency-trading-courses-5111984
Killexams : Māori Art and Design Studio IIA - Toi Atea

Course planning information

You need to complete the above course or courses before moving onto this one.

197217

The courses listed above have similar content to this one meaning you can only enrol in this course or one of the listed courses. Only one of the courses can be credited towards your qualification.

General progression requirements

You must complete at least 45 credits from 100-level before enrolling in 200-level courses.

  • 1 Describe the concepts of whakapapa, whenua and turangawaewae and explain how central they are to an appreciation of Maori identity.
  • 2 Identify themselves using the appropriate Maori forms of mihimihi and patere.
  • 3 Produce a range of work in different mediums that express aspects of their own identity.

Learning outcomes can change before the start of the semester you are studying the course in.

Assessments

Assessment weightings can change up to the start of the semester the course is delivered in.

You may need to take more assessments depending on where, how, and when you choose to take this course.

Explanation of assessment types

Computer programmes
Computer animation and screening, design, programming, models and other computer work.
Creative compositions
Animations, films, models, textiles, websites, and other compositions.
Exam College or GRS-based (not centrally scheduled)
An exam scheduled by a college or the Graduate Research School (GRS). The exam could be online, oral, field, practical skills, written exams or another format.
Exam (centrally scheduled)
An exam scheduled by Assessment Services (centrally) – you’ll usually be told when and where the exam is through the student portal.
Oral or performance or presentation
Debates, demonstrations, exhibitions, interviews, oral proposals, role play, speech and other performances or presentations.
Participation
You may be assessed on your participation in activities such as online fora, laboratories, debates, tutorials, exercises, seminars, and so on.
Portfolio
Creative, learning, online, narrative, photographic, written, and other portfolios.
Practical or placement
Field trips, field work, placements, seminars, workshops, voluntary work, and other activities.
Simulation
Technology-based or experience-based simulations.
Test
Laboratory, online, multi-choice, short answer, spoken, and other tests – arranged by the school.
Written assignment
Essays, group or individual projects, proposals, reports, reviews, writing exercises, and other written assignments.
Sat, 01 Oct 2022 16:09:00 -0500 en-NZ text/html https://www.massey.ac.nz/study/courses/maori-art-and-design-studio-iia-toi-atea-237217/
Killexams : Conducting a pre-course survey

Have you ever wished that you knew a little more about your students?  Or hoped that students might take a moment to review materials needed to get started in your course before your course begins? 

If so, a pre-course survey may be just the way to get started in your remote or online course. More about survey softwares available at SFU

Learning about your students: What do you want to know about them?

A survey can help you conduct a needs assessment about where your students are at in terms of prior knowledge, mindset, learning preferences and which tools are available to them.  

For example, in a remotely learning situation, it might be helpful to learn about your students access to technology or learning environment.  Below are some sample questions that could help you get started:

Please indicate whether you have access to:

Hi-speed internet Yes No
A fairly new laptop or computer (less than 3 years old) Yes No
A webcam Yes No
A suitable workplace (i.e. quiet, distraction-free) Yes No
The course required software Yes No

Perhaps it may be useful to you to ask your students about where they are currently living to inform decisions about asynchronous and synchronous activities.

Helping your students review information they need before the course starts?

Giving your students an opportunity to quiz themselves about how to get started in the course, how to navigate the course, and course expectations can help them get orientated and you clarify any misconceptions.

Below are some questions that could help you get started:

I understand how to participate in all course activities. Yes Somewhat No
I understand how to submit assessments (i.e. assignments, tests, essays) for grading. Yes Somewhat No

I think the course syllabus, including information about due dates, assessments, or course navigation, is clear and well organized.

Yes Somewhat No
I understand where to find the information I was looking for about the course. Yes Somewhat No

Giving students an opportunity to reflect early on learning strategies through a pre-course survey can help set the stage for success.  Below are some open-ended sample questions.

What are some strategies that you can use in this course to learn?
What could your instructor(s) or TA(s) do to Improve or better support your learning experience this semester?
Please describe any online teaching strategies you find particularly useful (give enough detail that a teacher could adopt the strategy).
Fri, 28 Jan 2022 22:14:00 -0600 en text/html https://www.sfu.ca/setc/instructors/next-steps/pre-course-survey.html
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