why is there a hold on LL? It is because the FDA has no proof that it is safe.
In their eyes, it could be very dangerous. They didn't go on here-say, they go on data which they never got from Amarex. So they were told by Amarex that it is safe. There were no incidents for many years. So the trials continued.
Until those 2 cardiac SAEs in the Brazil trial which led to the hold.
So what will lifting the hold do? Yes, it will allow LL to be used in trials. But, it will do far more. In essence, it becomes a declaration from the FDA that LL is clinically and scientifically safe. When they lift the hold, they say that LL is safe and they will stand by that until another Serious Adverse Event occurs.
In order to get approval, you need a declaration of Safety from FDA, that the drug is safe. Lifting the hold is that declaration. All the work CytoDyn did to scientifically prove that LL is safe was by essentially re-writing the BLA for HIV MDR. That BLA has been, for the most part, re-written. Lifting the hold, is akin to accepting that BLA for approving purposes.
This is not to say that CytoDyn will re-submit the BLA, but they could really, since it really is finished. I believe there were some issues in collection of the primary endpoints and that may be part of the reason why the FDA wants a re-write on the protocol for HIV trials as there may be an issue with how the primary endpoint is obtained.
Maybe the FDA wants to see another endpoint...
No, I'm not suggesting that arbitration is delayed until LL is approved. Hopefully, only a short time period following lifting of the hold. Even a fourth or a fifth of a rightful rough estimate would be enormous and satisfactory by me.
If the FDA finds that in order to obtain approval for HIV, CytoDyn will have to do another trial with the new protocol, then what the heck was Amarex conducting a trial with a piss poor protocol in the first place for? More sabotage?
We now know LL is safe. We met p value by 16x. But the protocol was off?
In their eyes, it could be very dangerous. They didn't go on here-say, they go on data which they never got from Amarex. So they were told by Amarex that it is safe. There were no incidents for many years. So the trials continued.
Until those 2 cardiac SAEs in the Brazil trial which led to the hold.
So what will lifting the hold do? Yes, it will allow LL to be used in trials. But, it will do far more. In essence, it becomes a declaration from the FDA that LL is clinically and scientifically safe. When they lift the hold, they say that LL is safe and they will stand by that until another Serious Adverse Event occurs.
In order to get approval, you need a declaration of Safety from FDA, that the drug is safe. Lifting the hold is that declaration. All the work CytoDyn did to scientifically prove that LL is safe was by essentially re-writing the BLA for HIV MDR. That BLA has been, for the most part, re-written. Lifting the hold, is akin to accepting that BLA for approving purposes.
This is not to say that CytoDyn will re-submit the BLA, but they could really, since it really is finished. I believe there were some issues in collection of the primary endpoints and that may be part of the reason why the FDA wants a re-write on the protocol for HIV trials as there may be an issue with how the primary endpoint is obtained.
Maybe the FDA wants to see another endpoint...
No, I'm not suggesting that arbitration is delayed until LL is approved. Hopefully, only a short time period following lifting of the hold. Even a fourth or a fifth of a rightful rough estimate would be enormous and satisfactory by me.
If the FDA finds that in order to obtain approval for HIV, CytoDyn will have to do another trial with the new protocol, then what the heck was Amarex conducting a trial with a piss poor protocol in the first place for? More sabotage?
We now know LL is safe. We met p value by 16x. But the protocol was off?
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