Replies to post #22378 on Relief Therapeutics Holding AG (RLFTF)

[randychub]

You could expand 3 to or they are not sure if it will meet its endpoint.

I would think they work increase the size of the trial though if that was the case

[Whalatane]

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