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Posted On: 11/23/2023 8:25:15 AM
Post# of 148863
Happy Thanksgiving to most of you!
Ohm, the meeting he's talking about is the one where Cytodyn gathered together experts and patient advocates to go in front of a panel at the fda to make the case for Leronlimab. (Pro140 if you nasty)
I am of the opinion that even if the fda decides that Leronlimab is worthy of an approval for whatever that indication is, they're still going to require AT BARE MINIMUM (caps for those of you in the back of the room) for Cytodyn to go through the typical motions of the BLA process. Meaning, they'll have to compile it and submit it. Then they'll have to wait like any other company would, for the fda to take their six months to decide on an approval or not.
This would be if the trial protocol requested is for a phase 4, post-approval trial. Therefore, the shortest time to an approval would be however long it takes to get that protocol fully approved by the fda plus however long it takes to compile a proper BLA submission, plus six to ten months for FDA review.
They're not in the business of letting companies skip a bunch of their ridiculous steps.
We don't know for sure though, that the protocol request is for a phase 4. Without more information it's just as likely the request is for a required trial before any BLA could be submitted. And if that's the case we're looking at maybe a year to get that trial initiated, filled, completed, and assessed. THEN we have the time to compile a BLA + the time it takes the FDA to review and decided. A year and a half to two years on the high end? Maybe? Hard to know without knowing what that trial protocol entails. Maybe it's a trial that can be run much faster than I'm guesstimating.
For the record, I'm leaning toward the trial being necessary before approval, but I'd love to be wrong. And either way it's a big, fat win for Cytodyn that we'd be looking at a near term (in the biotech world, at least) chance for approval in HIV.
Something we thought was completely off the table at the beginning of this year.
Now, if you'll excuse me I need to braise some short rib and break out the cooking* wine.
*wine you drink while cooking
Ohm, the meeting he's talking about is the one where Cytodyn gathered together experts and patient advocates to go in front of a panel at the fda to make the case for Leronlimab. (Pro140 if you nasty)
I am of the opinion that even if the fda decides that Leronlimab is worthy of an approval for whatever that indication is, they're still going to require AT BARE MINIMUM (caps for those of you in the back of the room) for Cytodyn to go through the typical motions of the BLA process. Meaning, they'll have to compile it and submit it. Then they'll have to wait like any other company would, for the fda to take their six months to decide on an approval or not.
This would be if the trial protocol requested is for a phase 4, post-approval trial. Therefore, the shortest time to an approval would be however long it takes to get that protocol fully approved by the fda plus however long it takes to compile a proper BLA submission, plus six to ten months for FDA review.
They're not in the business of letting companies skip a bunch of their ridiculous steps.
We don't know for sure though, that the protocol request is for a phase 4. Without more information it's just as likely the request is for a required trial before any BLA could be submitted. And if that's the case we're looking at maybe a year to get that trial initiated, filled, completed, and assessed. THEN we have the time to compile a BLA + the time it takes the FDA to review and decided. A year and a half to two years on the high end? Maybe? Hard to know without knowing what that trial protocol entails. Maybe it's a trial that can be run much faster than I'm guesstimating.
For the record, I'm leaning toward the trial being necessary before approval, but I'd love to be wrong. And either way it's a big, fat win for Cytodyn that we'd be looking at a near term (in the biotech world, at least) chance for approval in HIV.
Something we thought was completely off the table at the beginning of this year.
Now, if you'll excuse me I need to braise some short rib and break out the cooking* wine.
*wine you drink while cooking
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