Replies to post #391065 on Anavex Life Sciences Corp (AVXL)

[BarrellofHay]

Well, if I was an FDA decision maker and saw that 10-15% of the population improved -4 from baseline after 48 weeks when most patients deteriorate +4, I would be inclined to approve just based on this and the safety profile even if the 85-90% "other" patients did not show much of a mean difference, as long as they were not getting worse than placebo, which I am sure they are not. This is life changing for 600,000 to 1 million Americans. Now if you can find a biomarker for this population, then the FDA would have to approve, there would be zero reason not too. With 10-15% super responders and a biomarker = 100% approval chance as long as safety is good. 10-15% super responder without a biomarker, I give 80% chance on this alone.

[WilliamMunny]

Boi, please help me here and clarify, is it your understanding (as it is mine) that the 10%-15% super responders that Macfarlane alluded to was the percentage across all of his patients in the study - placebo plus both dosage arms, 30mg and 50mg? (If so, the percentage among the 50% arm is likely to be an extremely impressive number.)