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Re: Doc328 post# 449506

Friday, 01/26/2024 5:54:20 PM

Friday, January 26, 2024 5:54:20 PM

Post# of 459684
Two misguided and ill-informed statements...

The 273 AD study was indeed too short at 48 weeks and will be one of the reasons that it is not can to be accepted by regulatory agents (a more major point is that the study failed using standard criteria)


The EMA, after reviewing all the data (both published and unpublished) recommended that Anavex submit for full approval. Beyond stat. sig. scores with p<0.025, there's ample data with OLE and RWE results that demonstrate clear effectiveness (i.e. strong responders) with an excellent safety profile.

Rett at 12 weeks had precedence with the trofinetide trial, though in my opinion both are too short and neither of them seemed to have much of a benefit over placebo, definitely not 1/2 million a year of benefit


Not only was blarcamesine shown to be more effective than trofinetide, the RS-003 placebo score was better than trofinetide. Seems you're discounting all the QoL improvements in these patients, especially the reduction in seizures... which is huge. Again, with an excellent safety profile. The RS Org is firmly behind Anavex.
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