Replies to post #452606 on Anavex Life Sciences Corp (AVXL)

[Hosai]

I think FDA will look at whole picture in regards to RETT.

The placebo group did even better than the trofinetide drug arm which obviously went on to be approved. The Blarcamesine group did slightly better than this placebo but not enough to be significant.

The approved Trofinetide also one could argue may have had an un-blinding effect against their own placebo group, with 60% odd who the highest dose in the phase 2 having diarrhea. This was the lowest dose used in the phase 3 which led to 80% odd having diarreah, fairly sure this would have been a symptom to look out for.

I can't really see why the placebo should have done so much better for Blarcamesine than Trofinetides beyond randomness, unless Blarcamesine was inspiring more hope in people than Trofinetide. Perhaps that might go to show the excitement the drug is giving in regards to results in Alzheimers etc.

FDA will look at the data and think the best thing for RETT patients is to be on Blarcamesine trials...as drug arm or placebo they will be better off than the currently approved drug.

Also the adult trial was a success. There was some controversy with the end points however the company essentially stated the clinical trials site should not be relied upon as it's too slow and isn't actually mandatory. This was actually illustrated again with the girls trial as the clinical trials site actually only had the RSBQ end point not CGI-I so would have actually made them the trial look better.