Replies to post #448394 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

It can, but Anavex haven't submitted the MAA. By the time they do, it will be impossible that the final opinion will be this year.

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.