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Re: Jonjones325 post# 452588

Friday, 02/23/2024 6:05:25 PM

Friday, February 23, 2024 6:05:25 PM

Post# of 462048
Consider this: If the Rett trial had turned out significant Missling would be a hero and Anavex would be off to the races. Alas, the results didn't come back significant.

Those trial design decisions were made a long time ago. In hind sight it has been argued that the trial should have been larger. That may be. At the time the decision was made about the trial size the results from the previous Rett trial made that look like a pretty good choice. The trial got hammered by the joys of random selection. Shit happens. Type II errors occur.

It still remains to be seen how the FDA will react to those trial results. Are we going to say Missling is a hero if the FDA allows the Rett NDA to go forward and say that if the FDA requires an additional trial that Missling is a zero? There is something wrong with that metric.

Nunc est Bibendum

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