Replies to post #50080 on Cytodyn Inc (CYDY)

[MrGuru]

Branster,

Thanks but, remember the data requested by FDA was 700mg in MONO (not combo for which the application was being applied for).

If CYDY had not been testing in mono the FDA would had been "happy" ? After such outstanding results ??. Are we victims of our success ??

"IF 700mg would have been left out completely then no additional info would have been required"

It seems so ...

What about approving 525mg and demanding continuing studies about dosage optimization in light of the safe data at larger amounts ?? I have seen many approvals with post-investigation clauses. More so when there are excellent tools such as CTC count and occupancy tests available.

[Emergcy]

I have been working 40 years in industry, but when I come to turnaround jobs, I always following the 80/20% rule. 80% done, ok, then what is next bigger issues. In clear text: If 500 mg is already excellent and is much better than anything on the market, why to lose so much time for fine- optimization? Why to apply in such unnecessary way and giving 2 options to decide? I also always following the rule: Who asks much, who will get many answers!

The delay isn't the problem of FDA, NP should have never asked for 725 unless he wouldn't have been sure he would not get the approval for 500 mg, but I understood that everyone was very happy with results of 500 mg.

I am either not sure about the game of BP and FDA, but this was NP's not so smart approach. Many questions...many answers. He is old enough to know this rule.