Replies to post #417066 on Anavex Life Sciences Corp (AVXL)

[Kb1123]

It may not be a slam dunk but if we can show that our drug is better than the SOC and we have data that support the theory than the drug should be approved. Wether that’s thru AA or straight up approval it doesn’t matter.

[Investor2014]

Yes this imo.

I also think it's possible that the results may have been okay-but-not-great and Anavex is concerned the FDA will want a larger and longer confirmatory trial. Our trial had about 500 patients and ran for 48 weeks. The big lecanemab trial had about 1800 patients and ran for 18 months. Lilly's Phase 2 for Donanemab had 272 patients and ran for 72 weeks; and its upcoming Phase 3 will have 1500 patients and "duration including screening and follow-up is up to 93 weeks."

My belief is that the size and duration of the P2b/3 might have been adequate had the results been wonderfully clear and convincing but not adequate for results that were just okay. I don't in the slightest blame Missling for the trial size and duration; Anavex doesn't have BP's financial resources, and I think he did a great job in light of that. But the FDA may want a not-shoestring confirmatory trial.

Very unlikely to see full traditional approval from only two trials; the first a very very small and open label P2a with very small unreliable subgroup outcomes, and the second P2b/3 not that large with inadequately convincing overall TLR outcome, but clear subgroup signals correlating to potentially acceptable, rather than prior accepted, surrogate endpoints.

The idea that Anavex are simply strategically and cunningly hiding an amazing updated TLR, is frankly ridiculous.

I agree none of this is bad. It is just far more realistic that the fantasies of no further trials being required. It seems to me the market, rightly, is expecting P3 and then potential approval in 3 - years and thus no huge drop in $AVXL price, but a big jump should AA materialise as a big unexpected bonus.

That Anavex may now have a shot at AA, while prudently already announcing that a confirmatory trial is necessary and planned, as we have already been told in writing is great news and the most efficient plan for two shots at the AD goal. One of them might lead to revenue earlier than the other - if at all, but imo very likely so provided the next P3 trial being planned enrolls only responders to A2-73 by whatever biomarker criterion found/confirm by the P2b/3 data.

If that trial is initiated by Anavex prior to a potential AA decision, then it is a P3 PM trial. If the confirmatory trial is initiated after a potential AA, it will be a P4 and thus not one already planned and designed by Anavex, but one that will be agreed on FDA terms and guidance.

Anavex, per their own statement, is yet to seek potential AA pathways guidance from the FDA. All common sense logic tells us that Anavex is planning and will be initiating a P3 PM trial prior to any potential AA decision. At this point there is no guarantee that AA will even be on the table. Hence, very prudent to proactively initiate a confirmatory P3 trial, rather than wait for an inflection point known already to require a confirmatory trial.

[abew4me]

Quote: "...but I believe my theory for a possible non-PM trial is plausible, and we can't guess well between the possibilities without knowing more. If the theory is correct, and the surrogate biomarker evidence is good, we'd be on our way to getting 2-73 to the Alzheimer's market "relatively soon" (well before another trial is completed) while not limiting the population it can treat."

Joseph...Did your clinician friend contribute to this theory or is this your own?

Same quote: "If the theory is correct, and the surrogate biomarker evidence is good, we'd be on our way to getting 2-73 to the Alzheimer's market "relatively soon" (well before another trial is completed) while not limiting the population it can treat."

Perhaps this is why Anavex has been preparing for commercialization?

[Hoskuld]

While the TLR claimed that endpoints were met, it fell short of including the standard support for that claim, which is weird.

This is oft repeated here without basis. The TLR is not the full data and analysis release. Sell if you don't believe the company when it said it met the endpoints. Please.