Cytodyn Inc (CYDY)

[rdraindrop]

This is from Reddit user u/Upwithstock ;

EUA Debate

EUA's Debate!!
I have read some posts regarding EUA's and I thought I would clarify a few things points:I having been in the medical device space for 29 years and some of those years working closely with my regulatory colleagues to help them submit our FDA applications.
1) The FDA process for EUA's: Companies have to apply for the EUA. I have read comments like "the FDA rejected the EUA from CYDY". That is not the case. An 8K will be issued within the allowed window, that CYDY submitted an application for an EUA. This submission would be considered "material news" and CYDY has not revealed that yet!


2) FDA approvals and EUA's can be conditional. YES, in fact all approvals are at a minimum conditional because they involve labeling. The labeling contains the conditions/indications for use. Other conditional approvals or EUA's pre-specify exactly what conditions the FDA might impose. Many products get an approval and the condition is that the FDA still wants more data and requires the company to continue with a Post Market Study. The FDA has the ability to do that with Leronlimab, if CYDY could submit their CD12 data (Which FDA has already seen) and on CYDY's application. CYDY could state "we are requesting EUA for COVID Critical patients." The FDA could GRANT an EUA to CYDY for that indication with the condition that they also complete the CD16 140 patient trial.
On the conference call NP in his prepared remarks mentioned at the 5:52 time frame that an EUA could be submitted with CD12 data. But, we all know NP, later on during the Q&A session he was not as clear. In fact, he implied, an EUA submission for CD16 followed by the BLA and full approval.

3) EUA's and Full approval are different and they are not the same. However, they both allow the company to begin marketing/Selling the product under the conditions imposed in the EUA or Full Approval...and you should know that the FDA does not use the word "approval" they use the word "Clearance" . They "clear" a product for use, and then they name the indications/conditions.


Nonetheless, I hope that clarify's a couple of things regarding EUA's and I hope that TEAM CYDY feels that they could/should submit an application for an EUA using other data points that point towards COVID Critical patients.