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mauismart

10/17/25 8:58 PM

#503508 RE: MayoMobile #503507

They applied for full approval. Thats what they will receive.
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tschussmann1

10/17/25 9:46 PM

#503512 RE: MayoMobile #503507

I was thinking something similar: if the EMA feels it would not be appropriate to deprive citizens of such a breakthrough treatment for early Alzheimers, a recommendation might be: approval for all genetic variants, with the condition of data collected and compared by genetic sub-type against expected results if no treatment given. Anavex is supposed to be publishing a paper on this topic...so the procedure would be similar to the analysis that led to the paper.

If this turned out to be the condition, then I would expect that most genetic subtypes would show strong performance, with perhaps 10 to 30 percent showing less. The EMA would then decide on what the path should be for the lesser performing group(s), once the data had been collected over an adequate period of time. I would not be surprised if this period of time was at least two years.