Anavex Life Sciences Corp (AVXL)

[skitahoe]

As I see it the next big move up should come with the announcement of filing for approval in Europe, the question is, how much higher.

Nearly 11 months ago NWBO made a similar application to the UK, while their target is supposed to be 150 days, plus 60 if there are RFI's, it's clearly taking far longer and hopefully they'll get it done in under a year. I don't know if Europe is any faster than the UK.

I'm not a big fan of the FDA, but at least they establish a PDUFA date, and an answer is normally forthcoming by that date. Occasionally the answer is a delay of the date, but normally it's yes/no/or conditionally yes.

It's my belief that most approvals do lead to additional trials for label expansion. If that's the case, a conditional yes may only require additional trials that a company is planning to do anyway. The key is being able to sell a product, a confirmational trial is far better than being told no, run additional trials and we'll consider it again. I believe very few trials that result in conditional approvals ultimately have the approval pulled as the confirming trial fails to show the required benefit.

The question in my mind is, does AVXL intend to file with other regulators before getting an answer from Europe. If they do, additional approvals in late 2025 or 2026 are possible. If not, assuming that most of 2025 is spent in European evaluation, other applications probably won't be submitted till 2026, so approvals in late 2026 and more likely 2027 are probable.

Let's hope that the company's intent is filing elsewhere before the initial approval, hopefully in just a matter of month after the initial submission.

Gary