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Sunday, March 05, 2023 2:44:38 AM
“We'll be getting a proper topline (and full) results disclosure for our AD trial at some point”
Because this would have been calculated long ago, meaning shortly after the CTAD rush job, and if any good announced.
Instead Anavex have blindsided the P2b/3 situation, continuing the deep work on the full KEM analysis in the background, while hopes of EXCELLENCE will save the day.
Once ready, like the P2a peer reviewed paper, the P2b/3 data will be released showing great subgroup signals.
Those signals may be stronger, similar but not identical in terms responder characteristics to the P2a conclusions, and more dependable given the this time controlled and larger trial.
This data will also be discussed with regulators as soon as ready and probably before we see them in a publication. If good enough for some kind of accelerated approval somewhere, that will be released and would be great news.
If not, we will hear of a P3 PM trial alongside those in PD and PDD. All of which would need the funding access recently announced.
All imho of course and I accept flies in the face of the ‘met all endpoints’ statement, which should probably have been worded ‘met all objectives” like we saw with a previous P2 CNS trial with great signals.
I hope to be wrong about this assessment and from that learn how a biotech can know that all endpoints of trial were met without being able to show how.
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