MindMaze Therapeutics Holding (RLFTF)

[Whalatane]

Insight ..The IV trial was powered for 144 patients . This means in my layman understanding of bio stats ....that based on the risk profile of those enrolled ...they need 144 patients in long enough to hopefully get a statistically significant result ...less than a P value of .05 ...and preferably a P value of .01 .....So they could say to the FDA that they have data they believed to be 99% true ...P value of .01 .

They have to rule out / reduce , the role of chance.

So far we have data on 21 ? in an open label trial that's very encouraging BUT its not enough to say with 99% certainty ( P value .01 ) that we would see the same results with the next 21 patients.

They also need data on who RLF-100 works best on and best time to prescribe ( my guess is soon as a hospitalized patient needs O2 support....ie BEFORE going on a Vent )

If RLF-100 is a good as we hope it is then the FDA will want this in as many hospitals asap ....as long as they are confident in the trial data .

What I would like to see is a notice that the trial is fully enrolled ...then we can count down to read out.

By the way there are trials that could have been stopped at an Interim analysis ...but the DMC and Co decided to run to full completion to get the most detailed results ( and best stat sig reading ) possible ...Amarins Reduce It trial being the one I'm most familiar with

Kiwi