CDiddy, not unlike PDiddy, isn't in the public eye
Post# of 154137
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Posted On: 07/19/2023 7:20:07 PM
CDiddy, not unlike PDiddy, isn't in the public eye as often these days but will still pop up here and there to remind you he exists and give you all the feels for the heyday of the board. I can only imagine that the reason he's not posting as often these days is because one of his rappers left the game to become a pastor and his other high profile rapper was killed in what many believe was an east coast/west coast beef.
We've all been there at some point.
Anyway, good to see you make an appearance CDiddy.
For the record, I don't think we get some sort of bombshell on the call next week. I think we get clarification on the roadmap to the next real catalyst though, and maybe that does involve a path to an approval for HIV but I won't believe that until I see it. Burn me once, burn me for four straight years and whatnot.
But what Jake wrote makes a lot of sense if you're trying to piece together a puzzle that helps explain the request for a protocol.
I also wonder about the regulatory action the FDA has taken against Amarex, as mentioned by the Mig in the PR announcing the call.
"We are very confident in our claims, in particular, due to the results of independent and FDA audits that have been conducted as to Amarex’s services, and regulatory action taken by the FDA against Amarex."
He doesn't seem to be referencing the "audit" the fda performed on each of Amarex's submissions because that's mentioned earlier in the sentence already. Then I thought maybe he meant the case against Kazempour, but that's really not against Amarex is it? And that's not being undertaken by the FDA.
So what is the regulatory action?
I have to believe that whatever it is only bolsters Cytodyn's case against Amarex, and it may help ensure a stronger relationship with the FDA moving forward. Hell, they may already be helping us with the informal meeting suggestion of a protocol. And yes, that could also be them stonewalling us, but when you go back and read all the shit Amarex was pulling and you see the repeated attempts by the FDA to get them to address insufficiencies, basically spelling out like Amarex was a five year old what they had to do to get it right, I hold out hope that they might view the newest incarnation of Cytodyn in a different light.
A release of the hold would be fantastic, which could be why they pushed it out two weeks. They do know when their meetings with the FDA are held and they do know when the FDA is supposed to get back to them with decisions. Though I still think that request for a protocol has monkeywrenched us with some originally unknown timeframe where they'll go back and forth, or request a final meeting that isn't on the books for a few months because they're backlogged.
As much as I'd like to think there could be a situation where we get approved for an HIV indication with a follow up confirmatory trial post approval, I just can't imagine we would go from a BLA everyone agrees isn't sufficient to an approval simply based on providing safety data requested by a safety hold and creating a new protocol that was requested during an informal meeting. I'll be the first to admit I was wrong if it happens, and I'd be ecstatic, but it doesn't really make sense when you hold up that up against what we know about the bloated, slow, and pedantic FDA.
Too soon for a buyout. Probably too soon for a partnership announcement of some kind too, unless the hold gets lifted before the call.
There's an outside shot they decide to move forward with a trial while we wait on the hold but that takes money and we ain't got it right now until the Amarex cash comes in or they raise some. Or partner, of course. Which seems like it isn't happening until the hold is released.
So I'm leaning toward greater clarification on the path forward, with the bonus that the eta for the hold lift and following catalysts isn't all that far off.
We've all been there at some point.
Anyway, good to see you make an appearance CDiddy.
For the record, I don't think we get some sort of bombshell on the call next week. I think we get clarification on the roadmap to the next real catalyst though, and maybe that does involve a path to an approval for HIV but I won't believe that until I see it. Burn me once, burn me for four straight years and whatnot.
But what Jake wrote makes a lot of sense if you're trying to piece together a puzzle that helps explain the request for a protocol.
I also wonder about the regulatory action the FDA has taken against Amarex, as mentioned by the Mig in the PR announcing the call.
"We are very confident in our claims, in particular, due to the results of independent and FDA audits that have been conducted as to Amarex’s services, and regulatory action taken by the FDA against Amarex."
He doesn't seem to be referencing the "audit" the fda performed on each of Amarex's submissions because that's mentioned earlier in the sentence already. Then I thought maybe he meant the case against Kazempour, but that's really not against Amarex is it? And that's not being undertaken by the FDA.
So what is the regulatory action?
I have to believe that whatever it is only bolsters Cytodyn's case against Amarex, and it may help ensure a stronger relationship with the FDA moving forward. Hell, they may already be helping us with the informal meeting suggestion of a protocol. And yes, that could also be them stonewalling us, but when you go back and read all the shit Amarex was pulling and you see the repeated attempts by the FDA to get them to address insufficiencies, basically spelling out like Amarex was a five year old what they had to do to get it right, I hold out hope that they might view the newest incarnation of Cytodyn in a different light.
A release of the hold would be fantastic, which could be why they pushed it out two weeks. They do know when their meetings with the FDA are held and they do know when the FDA is supposed to get back to them with decisions. Though I still think that request for a protocol has monkeywrenched us with some originally unknown timeframe where they'll go back and forth, or request a final meeting that isn't on the books for a few months because they're backlogged.
As much as I'd like to think there could be a situation where we get approved for an HIV indication with a follow up confirmatory trial post approval, I just can't imagine we would go from a BLA everyone agrees isn't sufficient to an approval simply based on providing safety data requested by a safety hold and creating a new protocol that was requested during an informal meeting. I'll be the first to admit I was wrong if it happens, and I'd be ecstatic, but it doesn't really make sense when you hold up that up against what we know about the bloated, slow, and pedantic FDA.
Too soon for a buyout. Probably too soon for a partnership announcement of some kind too, unless the hold gets lifted before the call.
There's an outside shot they decide to move forward with a trial while we wait on the hold but that takes money and we ain't got it right now until the Amarex cash comes in or they raise some. Or partner, of course. Which seems like it isn't happening until the hold is released.
So I'm leaning toward greater clarification on the path forward, with the bonus that the eta for the hold lift and following catalysts isn't all that far off.
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