Anavex Life Sciences Corp (AVXL)

[Steady_T]

Several things come to mind after today's result and reading the board.

If Doc is right, even if this trial came out with ADL being significant this was never going to be approved as a single trial. He said that it was going to require a second trial as is the usual requirement for approval.

This trial has generated some important information that will inform the design of the next trial, if it is required. The ABCLEAR groupings are very important and will have to be included in the next trial design. The OLE demonstrated the effectiveness of slower titration and dosing at night. Those things were not known until the OLE got well underway.

At this point we do not know what the issues CHMP has with the trial that led them to the negative trend finding. Until we get to see the minutes of the meeting we really don't understand why they feel the trial is not approvable. It could be many things or just one thing. The company should have a good idea about the issues from the questions asked at the OE and I hope Missling will share that with us.

Leqembi was considered on a restricted subset of the population in the reexamination and that led to the approval with restrictions on who it could be prescribed to. A similar approach would seem likely for Anavex with the ABCLEAR 2 & 3 groups. Those would not have been looked it in the present application.

There is a reason that CHMP didn't give an outright rejection and sent a negative trend finding to the company. We don't know why they did that. The reason behind that decision is likely to be important for Anavex going forward. Perhaps the minutes will shed some light on that.

It appears that the minutes may not be published until after the December meeting so whatever is in play may not be known until after the December outcome.