Cytodyn Inc (CYDY)

[Saltz]

Grip is most likely correct. The acceptance by the UK to enroll in the S/C Trial is a telegraph as to how this is going to play out. This move allows the UK to participate and draw their own conclusions when the interim data becomes available. The P2 M/M trial is like an appetizer and the UK and EU are interested in the entree as is the case in the US.

The time line to S/C interim data is a minimum of seven weeks from today.

-Time to enroll 195 patients - 1 week.

-Duration of Trial - 4 weeks on drug.

-Collate interim data - 2 weeks

-Total 7 weeks. Mid October is aggressive.

IMHO Leronlimab’s success as a Covid therapeutic all boils down to the S/C results. There will be no gray area in this trial w mortality as the PE. The P2 M/M trial was investigational as NP stated and would have had to blow the PE away to receive EUA. It did not but it served its purpose by showing efficacy in a secondary endpoint.

Going for EUA abroad is right in NP’s wheelhouse - to create the most spin w what he has to work with - something he’s been doing for a lifetime. In this instance it worked out as it brought the UK to the table w the S/C Trial which is a win that gives Leronlimab much needed exposure outside of the US.

Reality is we need to get to the S/C interim and reveal the power of Leronlimab - this is where we have an opportunity to show significant results and gain clear separation from the field resulting in a possible EUA from the FDA or UK. Worst case scenario is all looks good at interim and the FDA and UK says complete the trial.