Cytodyn Inc (CYDY)

[justdafactss]

Hmmm, thats odd, most PhD's especially on linkedin will have it prominently affixed to their title. So not sure if the PhD thing is legit or not. So yes, lets see that transcript.

At any rate, no Right To Try if the FDA has issued a CLINICAL HOLD to CYDY---

Management will provide an update on ongoing work with the United States FDA and other regulatory agencies on using sub-population data to ensure future adequate trial design, in order to continue to further its clinical development of leronlimab in the treatment of patients with COVID-19. As indicated by the FDA and the Company previously, the CD12 trial did not meet mITT endpoints. The Company will provide further clarification on the secondary endpoints met in the critically ill pre-specified sub-population. As we continue to work with the FDA and other regulatory agencies, we ask investors to limit their outreach and respect the regulatory approval processes.
https://finance.yahoo.com/news/cytodyn-hold-webcast-may-18-234400533.html

Post from earlier this morning-

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