Replies to post #476760 on Anavex Life Sciences Corp (AVXL)

[vg_future]

Well said boi568. All these convoluted and long drawn theories seem pretty agenda driven. Anavex knows what it is doing and how it is positioning the submissions based on the guidance and discussions (that only Anavex and the agencies are privy to)…rest of this noise is just that…noise. Also, I cannot understand the non-stop drivel and attempts to desperately sling mud at one’s own “supposed investment” by few folks. IMHO, the best way to handle these messages is to not engage or entertain them.

-vg_future

[frrol]

While we're on the topic: the FDA draft guidance is specifically for early AD, and specifically addresses just two trial factors: diagnostic criteria and endpoints. Notably, it does not guide on trial size or dropouts.

What to make of this? A couple things are clear:
1. The guidelines arguably reduce the uncertainty or evaluator discretion on what is to be considered "early AD" and what is to be considered necessary endpoints.
2. The guidelines don't reduce the uncertainty or discretion on what is to be considered adequate trial size or excessive dropouts. Ie, they don't specify them.

This 'can be' good for us, if it means that #1 is their primary concern (ie, not trial size or dropouts rates). Whether that's true or not, can't say for sure. Furthermore as Doc has pointed out, are we 100% sure our population was truly overall "early AD"?

[frrol]

The EMA giving us a greenlight on submitting is great, and compelling to be sure, but the EMA folks from that greenlight are not the same folks evaluating submissions, the independent rapporteurs. This must be kept in mind, as about 15% of submissions on average are ultimately rejected.

[Investor2014]

ADL is one aspect of the trial design and there are others that clearly appears to need the totality of evidence from the P2a plus OLE, subgroup analysis, peer review, biomarkers / MRI to hopefully make it through to approval.

Separation of ADAS and SB from placebo was very late in the P2b/3 trial due to tolerability. Final n and lack of clear dose/response 30mg / 50mg another set of aspects that can’t be glossed over.

Overall the P2b/3 trial was not a clear winner, but we are in with perhaps even a good chance from the totality of evidence combined with unmet need.