The wonderful fact that Leronlimab can be used for
Post# of 154635
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Posted On: 10/13/2022 12:09:57 PM
The wonderful fact that Leronlimab can be used for many indications means, for the FDA I believe, that the safety data from all trials and LL usage can and should be lumped together.
Drugs that only treat one indication or a few have little or no safety data that can be lumped together. But with Leronlimab, you could be running a hundred trials and a bad safety signal in just one of them could shut all trials down.
This may have happened when the Brazil trials got a bad but false safety signal.
But the FDA is also not blind to the fact that several of Cytodyn's trials were done with a "questionable", to say the least, CRO. This tainted all of our trials that used Amarex until it is proven otherwise.
These are considerations particular to Leronlimab and Cytodyn that other drugs and companies usually don't have to face. Leronlimab is worth trying to surmount these hurdles, as Arman noted right off the bat in the last CC. Leronlimab has also allowed Cytodyn to assemble a very talented team who see these problems as "solvable".
I really hate to just "hope" that they are, those and other problems - but that's "investing"!
Drugs that only treat one indication or a few have little or no safety data that can be lumped together. But with Leronlimab, you could be running a hundred trials and a bad safety signal in just one of them could shut all trials down.
This may have happened when the Brazil trials got a bad but false safety signal.
But the FDA is also not blind to the fact that several of Cytodyn's trials were done with a "questionable", to say the least, CRO. This tainted all of our trials that used Amarex until it is proven otherwise.
These are considerations particular to Leronlimab and Cytodyn that other drugs and companies usually don't have to face. Leronlimab is worth trying to surmount these hurdles, as Arman noted right off the bat in the last CC. Leronlimab has also allowed Cytodyn to assemble a very talented team who see these problems as "solvable".
I really hate to just "hope" that they are, those and other problems - but that's "investing"!
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