Replies to post #178544 on Cytodyn Inc (CYDY)

[justdafactss]

Quote- CytoDyn has had to stop accepting the flood of EINDs

This appears to be a relevant reason----

IND Application Procedures: Clinical Hold

The plan or protocol for the investigation is clearly deficient in design to meet its stated objectives.
https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-clinical-hold#:~:text=IND%20Application%20Procedures%3A%20Clinical%20Hold%20A%20clinical%20hold,IND%20application%20may%20be%20placed%20on%20clinical%20hold.

First, we underscore the significance of a well-designed clinical trial when evaluating whether a medicine is safe and effective for a particular use. Well-designed trials have specific objectives, referred to as “endpoints”, that are documented (i.e., pre-specified) in the study protocol before the initiation of the investigation. Data obtained from the clinical trial are later analyzed using pre-specified statistical methodologies. If the analyses of the primary and secondary endpoints do not support conclusions of the medicine’s benefit, then FDA considers subgroup analyses to be exploratory, meaning they may inform the design of future trials, but do not support reliable conclusions about the medicine’s benefit. Focusing on only the most favorable of many subgroup analyses, even if the sub-groups are pre-specified, can lead to overestimating the evidence of benefit, because regardless of a drug’s true efficacy, some analyses are likely to appear favorable by chance when a large number of analyses are conducted.
https://www.fda.gov/drugs/drug-safety-and-availability/statement-leronlimab?Mon,%2017%20May%202021%2014:59:28%20EDT

8. If the IND for a drug is on clinical hold, is the drug an eligible investigational drug for use under the Right to Try Act?

A: No, a drug under IND clinical hold is not an eligible investigational drug and a sponsor cannot provide the drug for use under the Right to Try Act.
https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try

[kgromax]

Ah ah ah this is everything but rigorous scientifically.

I see on the internet many claims about "science" from authors who very obviously know nothing about real science. So let me synthesize a few key points.

The scientific method requires rigorously controlled trials, double/quadruple blinds with placebo arms to control for the placebo effect, a sufficient population to control for bad luck and predefined endpoints. This is the gold standard and the only one worldwide to deem a treatment effective. These EINDs & anecdotes were everything but that. Placebo effect, small samples that had uncontrolled mITT corrections, no predefined endpoint.

When this rigor was partially introduced - through the CD10 and CD12 COVID trials - magically Leronlimab missed all its endpoints. Despite supporters and hardcore fans predicting a few weeks before that "without a doubt" the results would be stellar. But but but ... the miracle vanished into the air.

Instead we got botched statistics that don't resist a 30 seconds examination by a professional statistician. One example: Nader acknowledged in a conf call that they DID NOT PERFORM P-VALUE CORRECTIONS TO ACCOUNT FOR THE DATA MINING. That, alone, KILLS FURTHER ANY P-VALUE NUMBER THEY DATA MINED. If you perform these corrections, their p-values (even filtering in/out patients by age, condition or number of days since onset) become ridiculously high, just pure noise.

Sorry, that's REALITY. Investors should consider exiting this mess that is only a stock promotion whose goal is to scam them and enrich insiders with their capital.