Replies to post #448388 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

First it doesn't appear that Anavex at this point based on their PR had requested AA.

Any request for accelerated assessment should be made at least two to three months before submitting the marketing-authorisation application.

Before submitting a request for accelerated assessment, applicants should seek guidance from the EMA procedure manager to ensure timely submission of their request.

EMA strongly recommends that applicants request a pre-submission meeting six to seven months before submission to prepare for evaluation under accelerated assessment. In this meeting, they can discuss their proposal for accelerated assessment with the Agency and rapporteurs from the CHMP and any other committees concerned, such as the Pharmacovigilance Risk Assessment Committee (PRAC) or the Committee for Advanced Therapies (CAT). They can present the data package and risk management plan they intend to include in their application.

The request for a pre-submission meeting should be sent electronically to EMA together with supporting documentation.

Under the PRIME scheme launched in March 2016, it is now possible for applicants to receive confirmation during the clinical development phase that their medicine might potentially be eligible for accelerated assessment.

Pretty sure Anavex would have already requested and had AA granted if that was possible, but instead the PR said:

“We appreciate the CHMP/EMA’s decision to deem blarcamesine eligible for a centralised regulatory review,” said Anavex’s Christopher U Missling, PhD, President and Chief Executive Officer.

Hence your point is moot, as Anavex is following the procedural timetable for full approval.

You can also study the: Procedural timetables

Bottom line is that Anavex is unlikely to get an approved/rejected EMA opinion this year!