Credits to Cytodyn Management (on the science front) in past year.
1. cd10 completed.
2. cd12 completed.
3. LH Ph2 completed.
4. Data collected and analyzed for 30 mTNBC patients.
5. Good efforts to initiate opportunities for Covid in Philippines and India.
6. Initiating trials for Covid in Brazil, building off cd12 data. Management has done its job here; it is up to ANVISA at this stage to have the trials go forward.
7. HIV BLA (second round) draft of dose justification submitted.
8. NASH enrollment 60 patients completed.
9. Communicates with shareholders promptly any relevant news through PR, proactive interviews, cc.
Current works and Projected goals for this year
1. HIV BLA timelines well-defined with final submission in October. (Being done following Communications/Guidance for FDA.)
2. Communications with FDA regarding LH & mTNBC results. (Depending on FDA response, potential LH trial later this year.)
3. BTD or Ph 3 in LH and Cancer.
4. Brazil trials, which will definitively answer our potential in Covid.
5. NASH results (possibly delayed here if we follow Dr. Recknor's desire for more patients and further bio-marker analysis.)
Discredits to Management
1. HIV BLA submission (first time) botched
2. cd10 trial. NEWS2 said to be secondary endpoint that was met. FDA in its letter flatly negated any such thing. Management refused to explain to its shareholders.
3. Management decision to not have interim look by DSMC at 75% enrollment cd12. Management decision to not take penalty for look at data. In retrospect only, this can be argued as foolhardy.
4. cd12 design could have been better, again only in retrospect. Fact is cd12 turned out to give more info regarding fine-tuning trial design for Brazil. So it was a stepping stone.
Current Management is doing good at this moment. No wish to ruin the potential. Yes we need results. Brazil can help the cause by approving the trial. Then HIV BLA, that is on management to make happen.
