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Nels At interim they chk the

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Whalatane   Wednesday, 09/23/20 04:57:35 PM
Re: nelskof post# 22378
Post # of 27773 
Nels At interim they chk the trial for powering . In my layman understanding ...to chk they still have enough patients enrolled long enough to provide statistically significant data.

I have seen the DMC's recommend previous clinical trials ADD patients to maintain powering of at least 90% .
So if the trial proceeds its always reassuring for the DMC to say ..."no changes required , proceed as planned ".

The last pt ..overwhelming efficacy . So the data the DMC is currently seeing may not be good enough to stop the trial as per the trials design ....but may be good enough to lend support for a limited EUA .

I dont know what the stopping criteria is for the Interim 2 . Even if its close the FDA may want them to continue to collect more data ...eg when is the best time to start treatment . Do any other adverse events besides reports of low blood pressure and diarrhea show up.
In which patients are these adverse events more common ...older diabetics ? for example .

FDA will be concerned about more adverse events once introduced to a wider population ....so a compromise may be a limited EUA and run the IV double blinded trial to completion .
JMO
running out of posts for the day
Kiwi

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