Cytodyn Inc (CYDY)

[Ambersavage7194]

(10) is too small and gives the FDA cover to say “get 50 patients” and come back

That's an accurate point. It is true compassionate use data can be used along with trial data to get BTD. However, the problem as you noted is the total number of patients even when combining the groups is lower than the average.

I believe the avg cancer drug that has received a BTD has around 40-50 patients. So the fact we're at 30 (combined) tells me we likely have too few.

Even if 30 is too few per historical data, it is still worth the effort to re-submit the BTD. Then we can at a minimum get more current guidance from the FDA. Maybe they say get us 20 more pts and if data remains the same there's a good shot. Maybe they say more than 20. Who knows. Still worth the time, as majority of the BTD application has already been completed.