Replies to post #435465 on Anavex Life Sciences Corp (AVXL)

[LBSR TO DA MOON]

Knoll Capital Management LLC reported a passive stake of 6.1% in ALDX as of September 28th, so they are obviously going to get hammered today. Hey, maybe they will decide to cash out of ALDX in order to cut their losses and come on back to AVXL in order to recoup them! hehe

[WolfofMia]

Cool, now do one where Dr. Kun Jin, who was recently appointed as Vice President, Head of Biostatistics at Anavex Life Sciences Corp is part of a company releasing this PR for the AD trial:

The trial is successful in meeting the co-primary endpoints if the significance of each endpoint is P < 0.05, or if the significance of only one co-primary endpoint is P < 0.025. If only one primary endpoint is significant at an a level of 0.025, then the secondary endpoint will be evaluated at the same level of 0.025. The trial was successful, since the differences in the least-squares mean (LSM) change from baseline to 48 weeks between the blarcamesine and placebo groups were -1.783 [95% CI, -3.314 to -0.251]; (P = 0.0226) for ADAS-Cog13, and -0.456 [95% CI, -0.831 to -0.080]; (P = 0.0175) for CDR-SB in patients with early Alzheimer’s disease.

MRI revealed significant reduction in brain volume loss, including whole brain (P = 0.0005), comparing treatment to placebo.

[ignatiusrielly35]

Looks to me like the FDA told Aldeyra that it simply does not see sufficient results of efficacy. There is no explanation of how or why. The 8-k says nothing about endpoints, or whether they were met or not.

[frrol]

It happens. Biotech management are optimistic, but some can get over their skis. In late stage development, the result is an otherwise avoidable CRL and up to a year of wasted time.

Our upcoming meeting with the FDA on our AD results will help us determine if we should try filing an NDA. Missling's judgement is not the greatest but we have an ex-FDA statistician now to advise him.