Cytodyn Inc (CYDY)

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On cd10, I am just guessing what they did. Neither FDA nor Cytodyn gave the details.

Cytodyn said the NEWS2 endpoint was met (p<0.05) for Days 3 and 14, so we understand also that it was not met for Day 7 (p>0.05). Cytodyn may be accused of misrepresenting this info in certain communications if they had claimed NEWS2 was fully met without mentioning in some clear manner alongside that "for days 3 and 14 and not day 7"; we have to go back and check the PRs carefully.

FDA just outright says we did not meet any secondary endpoint for cd10, so we have to assume that the NEWS2 endpoint (as a whole for the trial) was agreed upon as being met only if all three days showed success, or some sort of group evaluation showed good p value. It is not to the FDA's advantage in this acrimonious letter to acknowledge any sort of validity to Cytodyn's highlighting the data in positive light. So they went the other route and made it appear that there was nothing whatsoever - which for us investors is misleading in itself. The fact that we had p<0.05 individually for 2 of the days is still good stuff and it cannot be hidden or made to disappear simply because day 7 failed.

I don't recall the DSMC episode precisely but it is confusing as you say. We don't know what they saw at that point or how they thought the trial may succeed from there and the results turned out as they did. We also can't say what effect they saw from the 2 injections since we are mainly referring to the critical subgroup, and the DSMC was seeing the full group. But still they thought in the first check the trial should go ahead without changes. They did suggest a second DSMC check I think (after reaching a certain # of patients) which Cytodyn waved off saying we are already near full enrollment. (?)

On doses, I go with what Dr. Lalezari said. We did want 4 doses and FDA "pushed back" saying 2 was enough. He was ~ "never comfortable with that". It is easy to speculate retrospectively what Cytodyn should then have done. cd12 however has given us good info on where we should focus; we have fine-tuned the Brazil trials in a way that investors are comfortable and 'confident' based on the information from cd12 and eINDs.