The odds of the FDA giving any input yet are small
Post# of 155188
(Total Views: 627)
Posted On: 10/20/2020 8:16:25 AM
Re: invisioner #62110
The odds of the FDA giving any input yet are small / unlikely... This is the Data and Safety Monitoring Board / DSMB recommendation to CYDY, they're independent from both the FDA and CytoDyn.
The DSMB recommending trial continue is good: they see a signal in the LLMab arm
The DSMB recommending no expansion of recruitment total is great:
They have a strong feeling statistical significance (p=0.05) will be met with the number of participants already.
(I would go a step further and say they have already seen Stat Sig met, because halts usually take a much stricter p, say p=0.003, to justify a halt... Which I think LLMab is very close to hitting because....)
The recommendation to do another interim look at 75% enrollment is a fantastic sign:
There's no need to do that unless LLMab's p value is ALREADY CLOSE to a halt. It may be that all is needed is a few more patients / data points to cement a p value that will justify a halt, and their estimate is 75% enrollment would do the trick.
Out of all the possible outcomes to date, this is about the third best, behind:
-already meeting criteria for a halt and getting EUA,
-already meeting criteria for a halt and some form of acceleration initiated
I believe this all suggests "almost meeting criteria for a halt," soundly.
Or maybe fourth, if you count "resurrection of the dead" the #1 outcome
The DSMB recommending trial continue is good: they see a signal in the LLMab arm
The DSMB recommending no expansion of recruitment total is great:
They have a strong feeling statistical significance (p=0.05) will be met with the number of participants already.
(I would go a step further and say they have already seen Stat Sig met, because halts usually take a much stricter p, say p=0.003, to justify a halt... Which I think LLMab is very close to hitting because....)
The recommendation to do another interim look at 75% enrollment is a fantastic sign:
There's no need to do that unless LLMab's p value is ALREADY CLOSE to a halt. It may be that all is needed is a few more patients / data points to cement a p value that will justify a halt, and their estimate is 75% enrollment would do the trick.
Out of all the possible outcomes to date, this is about the third best, behind:
-already meeting criteria for a halt and getting EUA,
-already meeting criteria for a halt and some form of acceleration initiated
I believe this all suggests "almost meeting criteria for a halt," soundly.
Or maybe fourth, if you count "resurrection of the dead" the #1 outcome
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