I think on both cd10 and Cd12 NP and Amarex did a “shoot for the moon” trial definition for primary endpoint and missed on both cd10 and cd12. At this Point looking at Cytodyn , it needs to be a pragmatic review of management and their execution. It’s obvious the Cytodyn team at the time of the design of both cd10 and cd12 lacked experience dealing with the FDA. Our failure on the BLA review last summer for HIV along with both covid trials are results, not “hopes”..I “hope” other countries review and give us an EUA but there is nothing on the Philippine fda website showing approval to use this drug for EUA. no more “any day now” . That needs to be taken out of managements vocabulary ..if NP pushed all his chips in for an EUA for Covid at the detriment of HIV , the board should seriously review removing him . These are the risks CEOs take and when they are wrong, many are removed. Has NP bet the future of Cytodyn on cd12. It will be hard to tell, even after tomorrow’s CC. Did Canada really ask us to submit a request or did we ask them if it was ok and they said ‘sure’. At the rate this is going , long hauler results may come in before cd12.
On the cash side, a delay and more trials burning cash, screams “ where is the money coming from ?”...going back to the loan trough, a loan now will have more strings attached than before with higher interest rates. The path needed in my opinion is a big Pharma partner. These trials are hard enough when you have money. When you don’t and have money and limited management expertise , sometimes you have to bite the bullet . Minority interest or an outright buy out with a Pharma company who has the finances, political ties, etc is a path looking much more likely. Leronlimab is a great drug with unlimited potential . It wouldn’t be fair if this drug languishes and isn’t in the market place to change patient’s lives because of the management issues it needs to overcome. will it happen ?