The authority was chomping on the bit to find a re
Post# of 154141
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Posted On: 06/19/2023 10:32:24 PM
The authority was chomping on the bit to find a reason to slap a hold on LL, but they had nothing on it.
They were informed of the 2 SAEs and they took the bait.
It was a win - win for both, because CytoDyn got to present their data rightfully and was not misrepresented by that piss poor bla
amarex may have originally provided sufficient data to get CytoDyn into phase II and phase III trials, but soon thereafter, they stopped providing that kind of safety data to the authority. The quantity of missing information built and built to the point where CytoDyn would be in serious shit if a serious adverse event occurred. That "lack of data" doesn't happen in well run trials that you see on tv.
The data is always in proper GCP format. It is scientifically formatted and since in the proper format, as long as you statistically help more than you hurt, and you're much better than placebo, you can get approved.
CytoDyn could not prove that LL was safe.
The hold was not enacted b/c the data was unfit to analyze, but b/c there was no data to analyze. The authority had no data. Everything Amarex/CytoDyn offered was anecdotal. The BLA was missing factual data everywhere. The authority took one look at the BLA and returned an immediate RTF. The authority told both amarex and CytoDyn, you better have your BLA in tip-top shape before you submit it. They weren't kidding. They called a hold b/c CytoDyn wanted the hold so they could get their shit in order.
We are just about there. Hang on. Consider this:
Let's Get Into The Thick Of It
They were informed of the 2 SAEs and they took the bait.
It was a win - win for both, because CytoDyn got to present their data rightfully and was not misrepresented by that piss poor bla
amarex may have originally provided sufficient data to get CytoDyn into phase II and phase III trials, but soon thereafter, they stopped providing that kind of safety data to the authority. The quantity of missing information built and built to the point where CytoDyn would be in serious shit if a serious adverse event occurred. That "lack of data" doesn't happen in well run trials that you see on tv.
The data is always in proper GCP format. It is scientifically formatted and since in the proper format, as long as you statistically help more than you hurt, and you're much better than placebo, you can get approved.
CytoDyn could not prove that LL was safe.
The hold was not enacted b/c the data was unfit to analyze, but b/c there was no data to analyze. The authority had no data. Everything Amarex/CytoDyn offered was anecdotal. The BLA was missing factual data everywhere. The authority took one look at the BLA and returned an immediate RTF. The authority told both amarex and CytoDyn, you better have your BLA in tip-top shape before you submit it. They weren't kidding. They called a hold b/c CytoDyn wanted the hold so they could get their shit in order.
We are just about there. Hang on. Consider this:
Let's Get Into The Thick Of It
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