Replies to post #20339 on Cytodyn Inc (CYDY)

[trding]

Ibalizumab had 7 non-responders for PE. Picking 7 days and 0.5log as the success though does not give the full picture with p value. Those 7 could have had a 0.4log reduction on day 7 and 0.5log reduction on day 8, but counted as failure.


Same with Pro 140. Here is an old Pro 140 chart explaining that with a picture.

[BlueHorseshoe13]

Fred,
Your ability to read between the actual facts and find the “real” story is outstanding to say the least. How lucky we all are to have you to save us all from being blindly misled by the data and press releases. You are certainly the most credible of our available resources, and your opinion is obviously very valuable. Speaking of credible opinions, may I offer two more sources...

“These data clearly demonstrate the anti-HIV-1 activity of PRO 140 in antiretroviral treatment-experienced individuals who were documented to have ongoing virus replication in the face of therapy with currently approved drugs,” said Scott M. Hammer, MD, Harold C. Neu Professor and Chief of the Division of Infectious Diseases, Columbia University Medical Center/New York-Presbyterian Hospital. “Antiviral drug resistance is an ongoing threat to HIV infected persons. Despite the dramatic progress in treatment success over the course of the epidemic, we cannot be complacent. Agents with different mechanisms of action, modes of delivery, and frequencies of administration are needed to provide patients with the options necessary to achieve and sustain virologic suppression. PRO 140 is a clear example of the advances in HIV therapeutics that can result from the dedication of developers, patients and providers to this principle.”

“The standard approach to ART therapy has been to administer combinations of oral medications that must be taken daily,” said Robert T. Schooley, MD, Professor of Medicine, Department of Infectious Diseases and Global Public Health, University of California, San Diego. “Recently, there has been increasing interest in the development of drugs that do not require daily administration. I believe that PRO 140 is a step in that direction. These PRO 140 trial findings support the potential of managing HIV by blocking its entry into T cells through a novel humanized monoclonal antibody administered in weekly subcutaneous injections. PRO 140 could provide an important new therapeutic option in suppressing a patient’s viral load as well as deterring the spread of this disease.”

Maybe you could reach out to both of these uneducated professionals to enlighten them with your wisdom as well. Again, thank you for your contributions and saving us all from being overwhelmed by the facts.

[BlackDoggie]

This is the last I'll be responding to this conversation, because it's quickly becoming pointless.

First of all, the phase 3 trial for Ibalizumab was substantially dissimilar in that it was a single-arm open label trial as opposed to a randomized controlled double-blind trial. Similar endpoint measurements do not equate to similar trials, and also do not equate to wholly identical possible inferences of observed individual outcomes from statistical tests even with similar numbers of patients enrolled in the trial. I'm not saying that Ibalizumab isn't an effective drug or that their reported p value wasn't impressive or anything of the sort, just that this is not an apples to apples comparison when trying to impute the possible number of non-responders from trial to trial. Simply more intellectual dishonesty or lack of understanding.

Regarding the interpretation of the p value for the Pro 140 trial, I'll refer you here For more reading on the fragility of p values to non-responders in a randomized controlled trial:

https://www.sciencedirect.com/science/article/pii/S0895435613004666

I'll even do you a favor and quote the most relevant section:

Consider a hypothetical example in which two RCTs at low risk of bias evaluate investigational drugs compared with placebo for the prevention of myocardial infarction. In the first trial, 100 patients are randomized to receive drug A and 100 patients to receive placebo. Fewer patients who receive drug A suffer a myocardial infarction (one vs. nine patients, P = 0.02 by Fisher's exact test). The second trial randomizes 4,000 patients to receive drug B and 4,000 patients to receive placebo. Fewer patients who receive drug B suffer a myocardial infarction (200 vs. 250 patients, P = 0.02).

As both trials were at low risk of bias and their results demonstrated nearly the same P-value, one's confidence in a true effect might be similar. However, the results from the first trial would be easily influenced by a small change in the numbers of events. If only one more patient experienced a myocardial infarction in the treatment group of the first trial, the P-value would change to 0.06. Despite the still impressive relative risk reduction of 78%, it would no longer be considered statistically significant. In contrast, adding one event to the treatment group in the second trial would have no meaningful impact on either the P-value, which would remain 0.02, or the point estimate of the relative risk reduction, which would remain 20%.

Bold text is mine, and please note that the Pro 140 trial was roughly one quarter of the size of the hypothetical "small" trial in this (peer reviewed and journal published) article. This isn't a perfect analog to the Pro 140 trial either - but it's a damn sight closer statistically than the Ibalizumab trial. I'll leave you to draw your own conclusions since you seem to excel at that, and you may want to show that to your source who is intimately involved in drug testing as well. As an aside, I believe that your reference to non-responders in previous trials is likely actually a recollection of rebounders. While not ideal either, those are not the same thing. If you're recalling another trial, feel free to refresh my memory and I'll stand corrected.

Beyond this point, I would suggest that one's credibility has little to do with their own perception, and much to do with how others view them. Moving the goalposts significantly on multiple topics - saying "low" when you meant "high", saying "huge potential dilution" when you meant "I agree that counting all of the warrants as fully issued shares is a good idea", etc - and only shifting positions when twice publicly called to account, isn't a great method of building or maintaining credibility. Using false and/or misleading wording (re: p values) to protect the uneducated from themselves is also, at best, misguided altruism. I still believe that you misunderstand the statistics.

Last, your "point" about investor lawsuits from the most recent raise borders on insanity. I'm like a suburban white girl in Uggs with a pumpkin spice latte right now... I just can't even.

We can agree to disagree on certain points, such as the meaning or intent of the fundraising events/strategy, or the implications of the wording of a single PR. I'll even go so far as to agree that management worries me, and I lack faith in their abilities to generate the absolute maximum return on this company. However, too many of your claims are misleading or simply ridiculous.

[Inoviorulez]

Fred, I like your opposing point of view but please give it up. Pro 140 is going to market and big pharma is going to acquire it. Thanks for your info anyways, but don't fight the truth.