Cytodyn Inc (CYDY)

[LongTkt]

Tuesday Will Be Positive

Bad results would have resulted in an immediate trial halt. That didn't happen.

Releasing that statement in the dead of night and not releasing the results is an extremely bad sign. Fly by night PR is the kiss of death.

If it was bad news, NP would have scheduled the conference call for Friday after the market closes instead of waiting for Tuesday. I think NP was trying to hit his 'middle of the month' timetable which was October 15th.

The ACTUAL path forward is to run the trial to completion.

So what would a POTENTIAL path forward be?

1) Request an EUA based on overwhelming success possible (from what we know about EIND results and lower than expected total death rate of the S/C trial).

2) Change the study parameters - unlikely based on the knowledge gained during the EIND drug usage before starting the S/C trial.

It seems rushed that he wants to have a conference call Tuesday afternoon, if FDA and DSMC is also meeting Tuesday. I would have liked to see the call for Wednesday so there was more time to prep. I think NP (with his EGO) wants to be the one to report what the FDA/DSMC discussion was instead of risking it being leaked. I also think he wants to be the one communicating the great news to the world.

The use of slides is also telling. It indicates that they have some type of parallel trial pipeline or approval timeframe that is too difficult to effectively communicate verbally. Or they learned from the M/M study that positive trial data released in paragraph form might not be the best

With all that said, I still don't think an EUA will be submitted until the end of the month. The FDA acting on the EUA would bring approval to mid-November (If you use RGEN's EUA submission as a benchmark).