Replies to post #508523 on Anavex Life Sciences Corp (AVXL)

[Doc328]

I guess the cost and safety advantages just don’t trump efficacy and robustness in this setting.

I have failed to understand Missling's logic in wasting this year by applying for the MAA on flimsy data.

And then this inthe PR "FDA advises Company to meet and discuss Company’s Alzheimer's Disease clinical trial results" smh, he has not learned. According to Missling in either the Q2 or Q3 2023 CC, they would meet with the FDA buy year end. Also before starting a 2b/3 they would have done an end of phase 2 trial. The FDA is not advising them to apply but likely advising them that they can have another meeting if they schedule one. Is he trying to waste another year?

[Hosai]

"I also dug around and couldn’t find a single case where EMA approved a non-FDA drug based on a post-hoc genetic subgroup."

Doesn't the FDA approved become kind of a moot point once CHMP have rejected them. The FDA approved clearly didn't stop CHMP rejecting the MABs so it's doubtful it then had much effect in the decision to approve at re-examination.

The MABS sub group data had been pre-specified however it was still only put together as a proposal after the rejection. COL24 not pre-specified but p value is very low and importantly the COL gene is biologically very plausible. Will be interesting to see how many genes/variants they actually picked from coz obviously the higher the number the more risk of false positives but I don't believe Dr Jin would have put forward a subgroup that he knew would be viewed with scepticism in terms of false positive potential.
Regulators in general are more forgiving of subgroup data if the ITT was stat sig which the trial was with primary and secondary under 0.025p value however even if you viewed it as not due to ADL - both FDA and EMA seem to now be downplaying this endpoint.
The fact that Blarcamsine is also very safe (unlike the MABS even in the approved safer sub group) especially shown in the lower titration in the OLE means it would seem ideal for conditional approval especially in the ABLEAR3 group, what is there to lose from doing this? If it works could save the patients who start taking it now years of better quality of life. If it doesn't work the drug gets pulled in a few years, but the patients arguably have not lost anything other than some moments of very mild dizziness and the same AD deterioration as other AD sufferers.