Replies to post #467170 on Anavex Life Sciences Corp (AVXL)

[kund]

Should only take 3 months or so to release OLE results so I would guess some point in Sept (they said H2 rather than Q4 as they did for EMA submission).

H2 vs Q4 is another word salad from TGD. Even a company like BIVI took less than three months to release data, but Anavex seems to operate in a different world. TGD needs time to cherry-pick data, and that takes time.

Look at AD RNA data, it went form mid24 to h2, timeline is very fluid in Anavex land, it can just slip to next year and beyond.

[Investor2014]

We would be having none of these discussions if the P2b/3 trial had shown clear efficacy as per protocol and SAB priority incl. dose dependency. Instead we have massaged information and change of plans dripping out over a wait of more than 18 months by now since TLR.

It doesn't matter how hard you, or anyone, try to convince me by repeating the same Anavex unreliable information in this and that way. What I am saying is that full data analysis of the main trial against with correlations to genetic biomarkers in placebo vs. drug patients and then placebo patients on drug during OLE, may be helpful because it is objective even in a non RCT confirmatory trial scenario. Likely also what the KOL may have suggested to Missling.

That remains my opinion because I have seen, heard and understood the detail, which coupled with my experience in biotech investing has some relatively good (< 20%) chance of approval because of the unmet need and relatively good safety profile in AD patients. Even so I have hard time to imagine full approval, more likely some conditional and limited label approval with a follow on confirmatory trial - and yes I know what Anavex and Missling have said, but history shows that doesn't count for much.

Doc might be right about the 1% chance, but I am not that pessimistic if objective biomarker results supports the findings that Anavex are showing in completers only.