I think it's probably close or actually statistica
Post# of 148170
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.