Replies to post #127372 on Cytodyn Inc (CYDY)

[Vegas Stocks]

Great post as usual !

[All-Bidness]

The Covid BLA? Where did you see/hear that? As far as I know we were cleared to submit the HIV BLA for 350mg. I don't think the company can even produce a Covid BLA at this point as we don't have access to the trial data.

[ClosetInvestor]

“Consider only one event; Great Britain (GB) has asked for the COVIVID-19 BLA.”

When did the U.K. ask for the COVID19 BLA? The PR about he UK HIV BLA said that the MHRA had asked about the S/C interim analysis, but not about the BLA.


“The MHRA also had questions about CytoDyn’s recent COVID-19 Phase 3 severe-to-critical population interim analysis.”

There’s a big difference between inquiring about the interim analysis vs a COVID BLA.

[Blueheel1]

I agree. Our addition of this BLA expert to the team shows me that we’re learning and making some pivots here. Should we have done this sooner? Probably, but it is what it is.

To the extent we marry what I view to be a truly blockbuster molecule with execution on the regulatory side, we are truly off to the races.

[C-20]

Black-Ops well said I think our management has finally made the right decision hiring someone that has experience with getting the BLA across the finish line . Unfortunately you are correct I think our first approval comes from outside the USA. Our crooked gov’t continues to be on the take from big pharma instead of doing what is in the best interests of our country.