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Posted On: 10/16/2020 11:17:23 AM
Post# of 148987
Re: onestepahead #61460
I think it's probably close or actually statistically significant now, absolutely correct that under normal circumstances, a much smaller p value would be required to recommend a Halt.
We KNOW safety passed, recommended continued, one down.
We KNOW there were much fewer deaths than expected, regardless of which arm they occured in. What that suggests isn't a revelation for anyone following LLMab, or even other studies' mortality rates.
The unknown is what p is needed, in the FDA's mind, to decide it's seen all it needs to see. That's what we're waiting on, IMO, and it's up to the FDA regardless.
We KNOW safety passed, recommended continued, one down.
We KNOW there were much fewer deaths than expected, regardless of which arm they occured in. What that suggests isn't a revelation for anyone following LLMab, or even other studies' mortality rates.
The unknown is what p is needed, in the FDA's mind, to decide it's seen all it needs to see. That's what we're waiting on, IMO, and it's up to the FDA regardless.
Quote:
Fact #4 if we’re showing Enough mortality Reduction to finish out trail than DSMC May be giving recommendations based on non pandemic parameters such as if we were trying to get approval of a blood pressure drug the circumstances for a trail halt would be very slim since would
Need excellent super super low pvalue, well here the thing we’re in a pandemic and there is a HUGE unmet need for a SAFE mortality reducing live saving drug.
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