Replies to post #458342 on Anavex Life Sciences Corp (AVXL)

[Steady_T]

A little cut and paste for you. Bolding is mine.

Most of the references mention determination of the eligibility for Centralized Marketing as being done by the EMA. Most references don't say who within the EMA does the actual review. There are a few references that hint that the CHMP does the eligibility review others mention EMA staff.

I can't find anything that discusses the EMA having any staff capable of evaluating a Centralized Marketing application other than the CHMP.

Successfully navigating the centralized MAA process requires meticulous planning, proactive engagement and collaboration with EMA, and adherence to deadlines. The planning journey begins with the submission of an eligibility request to confirm eligibility for evaluation under the centralised procedure, using a specific form accompanied by justification of eligibility criterion fulfilment via EMA online portal. This step is required regardless of whether the product falls into the mandatory or optional scope of the centralised procedure. The eligibility request should be submitted 18 to 7 months before the planned MAA submission date and submitted to EMA 10 calendar days before the planned and published CHMP meeting date. Decision of eligibility is received in the week following CHMP meeting where the discussion took place.

https://www.rhoworld.com/planning-for-a-successful-centralised-marketing-authorisation-application-in-the-european-union/

[bas2020]

Nonsense! The EMA had already reviewed the data, and based on that review, made their recommendation to Anavex to submit for full approval. So, please stop with your pretentiousness.