Hi Gestalt, some friendly thoughts on your post (my views are always speculation based solely on publicly available information):
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"so, we partnered with some AI company to come up with other indications?"
-A.I. IS SIMPLY AN ADDITIONAL ASSET CYDY CAN LEVERAGE FROM A COMPANY CYDY PARTNERED WITH AND IT WASN'T FOR FINDING MORE INDICATIONS, PARTNERSHIP IS TO BOLSTER CYDY'S LONG-ACTING LERON DEVELOPMENT (USING A.I. AND VARIOUS OTHER METHODS). PERHAPS IT'S MICROSOFT, BUT WHO KNOWS? TBD. MORE HERE:
https://www.pharmaceutical-technology.com/new...discovery/
"We now gathered HIV patients to convince the FDA that this drug is worth the effort (why would the FDA need this? it is cytodyn's problem if nobody buy the drug - the FDA is just approving it.)"
-IT'S POSSIBLE FDA MAY BE USING THE ACCELERATED APPROVAL PATHWAY FOR LERON/HIV AND THUS WANTS CYDY TO SPECIFY WHICH POPULATION THE DRUG WOULD MOST BENEFIT, IN ORDER TO FACILITATE THE ACCELERATED APPROVAL. HOPEFULLY THIS IS THE CASE. ANTONIO ET AL SOUNDED PRETTY BULLISH, SO WE SHALL SEE. TBD.
"Based on these testimonials, we can tell the fda only one application for a specific HIV group that Leronlimab is good for the most so they can consider lifting a hold based on non-existent safety issue?"
-SEE MY PREVIOUS RESPONSE. NOTE THAT ONCE IT'S APPROVED FOR HIV, THE FLOODGATES CAN BEGIN TO OPEN FOR LERON.
"They need to authorize more shares. How about taking the amarex cash and buying back the shares that were authorized to pay them?"
-AUTHORIZING MORE SHARES DOESN'T MEAN THEY WILL BE USED, THEY ARE THERE JUST IN CASE NEEDED. I AGREE, A BUYBACK WOULD BE NICE BUT IT'S TOO EARLY FOR THAT TO BE REALISTIC.
We need to do a pre-trial for NASH before we get a partnership.
-HE SAID A PRE-TRIAL FOR NASH WOULD BE BENEFICIAL. DOESN'T MEAN IT'S MANDATORY. BUT IF THEY DECIDE TO DO IT, SO BE IT.
"sounds to me like we should file a BLA for HIV as we are spending so much time and money convincing the FDA there are HIV positive people that have a huge problem with side effects and drug resistance. (apparently the FDA is unaware)"
-A (FASTER, SIMPLER) VERSION OF THIS FILING MAY BE UNDERWAY ALREADY RE: FDA'S ACCELERATED APPROVAL PATHWAY. TBD. MORE HERE:
https://www.fda.gov/drugs/nda-and-bla-approva...al-program
"All other indications are years away at this pace, the only near term catalyst is getting the hold lifted and getting something out of Amarex. The good news is that they did state that they are seeking damages from Amarex and its parent company NSF."
-HIV IS NOT YEARS AWAY IF IN FACT ACCELERATED APPROVAL IS BEING CONSIDERED BY FDA. ALSO, A POSSIBLE ONCOLOGY PARTNERSHIP WITH MERCK/KEYTRUDA IS NOT YEARS AWAY AND WOULD IMMEDIATELY BOOST SHARE PRICE. NOTE THAT CYRUS ET AL SAID CYDY IS AN ONCOLOGY COMPANY YET NO MENTION OF ONCOLOGY ON THIS CALL. CONSPICUOUS ABSENCE OF THAT TOPIC SUGGESTS POSSIBLE NDA AND PARTNERSHIP ALREADY INKED, BUT NO ANNOUNCEMENT UNTIL HOLD LIFT AND STUDY RESULTS PRESENTED TO PUBLIC. TBD.
*All of the above is speculation on my part and I have no information that isn't publicly available. Just trying my best to connect the dots using H.I. (human intelligence).
I remain... #BULLISH
__________________________________________
"so, we partnered with some AI company to come up with other indications?"
-A.I. IS SIMPLY AN ADDITIONAL ASSET CYDY CAN LEVERAGE FROM A COMPANY CYDY PARTNERED WITH AND IT WASN'T FOR FINDING MORE INDICATIONS, PARTNERSHIP IS TO BOLSTER CYDY'S LONG-ACTING LERON DEVELOPMENT (USING A.I. AND VARIOUS OTHER METHODS). PERHAPS IT'S MICROSOFT, BUT WHO KNOWS? TBD. MORE HERE:
https://www.pharmaceutical-technology.com/new...discovery/
"We now gathered HIV patients to convince the FDA that this drug is worth the effort (why would the FDA need this? it is cytodyn's problem if nobody buy the drug - the FDA is just approving it.)"
-IT'S POSSIBLE FDA MAY BE USING THE ACCELERATED APPROVAL PATHWAY FOR LERON/HIV AND THUS WANTS CYDY TO SPECIFY WHICH POPULATION THE DRUG WOULD MOST BENEFIT, IN ORDER TO FACILITATE THE ACCELERATED APPROVAL. HOPEFULLY THIS IS THE CASE. ANTONIO ET AL SOUNDED PRETTY BULLISH, SO WE SHALL SEE. TBD.
"Based on these testimonials, we can tell the fda only one application for a specific HIV group that Leronlimab is good for the most so they can consider lifting a hold based on non-existent safety issue?"
-SEE MY PREVIOUS RESPONSE. NOTE THAT ONCE IT'S APPROVED FOR HIV, THE FLOODGATES CAN BEGIN TO OPEN FOR LERON.
"They need to authorize more shares. How about taking the amarex cash and buying back the shares that were authorized to pay them?"
-AUTHORIZING MORE SHARES DOESN'T MEAN THEY WILL BE USED, THEY ARE THERE JUST IN CASE NEEDED. I AGREE, A BUYBACK WOULD BE NICE BUT IT'S TOO EARLY FOR THAT TO BE REALISTIC.
We need to do a pre-trial for NASH before we get a partnership.
-HE SAID A PRE-TRIAL FOR NASH WOULD BE BENEFICIAL. DOESN'T MEAN IT'S MANDATORY. BUT IF THEY DECIDE TO DO IT, SO BE IT.
"sounds to me like we should file a BLA for HIV as we are spending so much time and money convincing the FDA there are HIV positive people that have a huge problem with side effects and drug resistance. (apparently the FDA is unaware)"
-A (FASTER, SIMPLER) VERSION OF THIS FILING MAY BE UNDERWAY ALREADY RE: FDA'S ACCELERATED APPROVAL PATHWAY. TBD. MORE HERE:
https://www.fda.gov/drugs/nda-and-bla-approva...al-program
"All other indications are years away at this pace, the only near term catalyst is getting the hold lifted and getting something out of Amarex. The good news is that they did state that they are seeking damages from Amarex and its parent company NSF."
-HIV IS NOT YEARS AWAY IF IN FACT ACCELERATED APPROVAL IS BEING CONSIDERED BY FDA. ALSO, A POSSIBLE ONCOLOGY PARTNERSHIP WITH MERCK/KEYTRUDA IS NOT YEARS AWAY AND WOULD IMMEDIATELY BOOST SHARE PRICE. NOTE THAT CYRUS ET AL SAID CYDY IS AN ONCOLOGY COMPANY YET NO MENTION OF ONCOLOGY ON THIS CALL. CONSPICUOUS ABSENCE OF THAT TOPIC SUGGESTS POSSIBLE NDA AND PARTNERSHIP ALREADY INKED, BUT NO ANNOUNCEMENT UNTIL HOLD LIFT AND STUDY RESULTS PRESENTED TO PUBLIC. TBD.
*All of the above is speculation on my part and I have no information that isn't publicly available. Just trying my best to connect the dots using H.I. (human intelligence).
I remain... #BULLISH
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