Replies to post #211305 on Cytodyn Inc (CYDY)

[Cindylou822]

In all honesty, the FDA should have a sandbox available to programmers and developers so they can see how the data transfer will work and how it will look to the reviewer so that internal auditors at pharma can do a final check before submission

[ClosetInvestor]

“The worst that happens is that they do double data entry inhouse into a database like EPIC, do their validation of the data transfer and send a bill to Amarex”.

The problems with the HIV BLA go much deeper than safety data. Read the RTF.
In addition to safety data, CYDY needs a plan on how to address the lack of RO data from a trial that completed in 2018.

[3X Charm]

LOL. What a bunch of amateurs leading Cytodyn. Idiot Nader and his incompetent friends at Amarex still haunt the company 4 years after the HIV trial. As Lalezari said…” the most incompetent and dysfunctional management he had ever seen”