Anavex Life Sciences Corp (AVXL)

[Investor2014]

Anavex will end up in ether the approved or not approved bucket, which by the Dec 2023 update is about 77% vs 23% across all recommendation to file a MAA.

That's exactly wrong.

The reasons for non approvals are here, which is predominantly because of withdrawn applications typically after Clock-stop 1 because the applicant is unable to respond satisfactorily to the agency's questions and requests, which was 19 and then 3 final negative opinions.

We see from the first link that 25 treatments recommended for approval were in cancer indications or about 1/3 of all positive opinions. The rest were:
6 in Cardiovascular
5 in Dermatology
3 Diagnostic agents
5 Endocrinology
2 Gastroenterology / Hepatology
5 Haematology / Haemostaseology
2 Immunology/ Rheumatology/ Transplantation
2 Infections
3 Metabolism
11 Neurology (a broad category where only 3 were Neurodegenerative Medicines and non in any form of dementia)
3 Ophthalmology
1 Pneumology/Allergology
4 Vaccines

55 indication and some of the drugs in multiple Therapeutic Areas making the total of 77 approvals.

Using this filter on the EMA page, we see that only 3 Neurodegenerative Medicines are in the 2023 stats non of them any form of dementia. Two were authorised and one withdrawn.

The point here again is that we cannot use the top level conflated overall approval versus withdrawn and negative opinion figures to imply a reliable chance of approval for A2-73 in AD. There simply isn't precedence data to base and approval chance on. All we can say is that it is somewhere between 0% and 100% .

We don't know what feedback, questions and requirements EMA may raise for Clock-stops 1 and if Anavex is able to satisfactorily reply and move on from there.

It is just plain silly to expect 85% chance of approval and as we can see the market isn't that silly.