Replies to post #391460 on Anavex Life Sciences Corp (AVXL)

[abew4me]

If this Q & A becomes a reality, it would demonstrate absolutely no compassion by the FDA to address the severe and tragic disease that Alzheimer's causes.

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Question: Do you rule out the possibility that the FDA would grant accelerated approval, with your one additional large study being designated a confirmatory trial, because A 273 appears to be active with super responders, and safer than the amyloid drugs, in a complex illness that has a great unmet need for beneficial drugs?

Doc's Answer: I think its very unlikely. Alzheimer is common and a larger study or two studies could have been done. Safety is good but not enough to get a drug approved.


(This is just shocking to me. If safety is good, why not give AA with an additional large confirmatory trial? This is just common sense in my opinion.)

[Rubyred77]

Do you not remember BIIB had neither last year….?

[12x]

The market has given 2-73 zero chance to be approved without another p3 trial, but I see following paths being discussed on MB. Too optimistic? Any other possible path?

Path 1 (pooled results/most straightforward): Anavex had it he TLD correct all along and FDA agrees
Risk: Anavex had odds ratio the top of the SAP and FDA agreed to it along with 1-tail p-value
Success probability: 10%

Path 2 (50mg/most likely among all): 50mg group meets all 3 endpoints and multiplicity (p<0.025)
Risk: FDA ok with the small size (~300)
Success probability: 60%

Path 3 (subgroup): wt subgroup analysis with/without 50mg meets all 3 endpoints and multiplicity (p<0.025)
Risk: FDA ok with the small size (<300)
Success probability: 20%

Path 4 (surrogate endpoint): either mRNA expression level, MRI or one bio marker shows significance and accepted by FDA
Risk: FDA opens door for non-AB pathways
Success probability: 20%