Replies to post #444600 on Anavex Life Sciences Corp (AVXL)

[Joseph_K]

Simple. If you read that series of my posts, I'm saying I believe Anavex will probably get EMA approval. Drugs can be approved even when their trials did not hit all their endpoints. I've read, IIRC, that 10% of the drugs approved by the FDA in the last several years did not succeed on all their primary endpoints and some of those approvals are for drugs that did not reach statistical significance on any primary endpoint. Additionally, it's possible that the interim open-label extension results for ADL, which the EMA probably saw, looked a lot better than they did after only 48 weeks. The chance of blarcamesine getting approved for marketing by the EMA would be higher if the P2b/3 had hit all its endpoints, but it's failure to achieve that doesn't mean the drug isn't a worthy candidate or can't be approved.

[Steady_T]

What we know is that whatever data Anavex showed to the EMA they thought it good enough to indicate to that Anavex it should move ahead with the MAA process.
That does not indicate that Anavex has submitted a letter of intent which specifies an intended date to submit an MAA.

Given Missling's habit of not sharing information, making any assumptions about where Anavex is in the letter of intent process is a risky guess.