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Re: Doc328 post# 391460

Sunday, 12/11/2022 10:37:24 AM

Sunday, December 11, 2022 10:37:24 AM

Post# of 519035
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%
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