Cytodyn Inc (CYDY)

[HyGro]

Show me one that meet a statistically significant protocol endpoint. You can't find one. The trials are too small, LL's performance was not strong enough. For example, Long CoV -- the NOWHERE did the company say the results met endpoints. Instead they referred to numerically higher difference -- that is directional and certainly not statistically significant. The company is only claiming HIV Phase 3 results are significant. That's all. And they were rejected for BTD.

mTNBC has only 10 patients in their trial. NASH open label is not claimed as statistically significant (again small trial).

The way companies get BTD is having statistically significant "breakthrough" results. mTNBC and NASH did not have them and were not "breakthrough" results even if they were. GvHD failed.