Replies to post #57366 on Cytodyn Inc (CYDY)

[Amatuer17]

“He should finally shut up about the BLA date and only make an announcement when he managed to do his job “

I agree on this - in fact I have been saying for last 6 months that BLA will be delayed much further than what NP promised in 2019 Dec.

With the cancer results he is seeing, I think that he is changing focus from HIV to Cancer and may deliberately delay it further under the guise of lack of funding.

I am fine with delay in HIV BLA submission as long as he pushes the Cancer trials.

[z_smith]

My issue with the delay of the BLA is:
1) It is not an issue with the FDA as NP keeps blaming. It is that NP doesn't know the process well enough.

2) An experienced CEO would know how to manage the risk. E.g., the FDA usually wants all the safety data. CYDY has only put together the safety data for 50 patients. An experienced CEO would put together the additional safety data, just in case the FDA would want it (as they typically do). The small incremental amount of cost for preparing the extra data is trivial compared to the cost of the delays not having the data has caused. That is basic risk management that any experienced executive would know.

3) The never ending over promise, under deliver. We have been expecting the BLA to be completed for far too long. And I thought CYDY was finally getting serious about filing the BLA by the much-hyped end of Sept. 2019.

I am still a big believer the product, but know that we would be in a much better position if we had more experienced leadership.