Anavex Life Sciences Corp (AVXL)

[tschussmann1]

Mayo, thanks for your thoughts. My question is in regards to admissibility of additional data beyond what was presented in the initial application. This section in the EMA documentation brings that to question:

20. Examination of grounds for appeal
The re-examination looks only at the points raised by the applicant in the grounds for appeal and is based only on the scientific data available when the committee adopted the initial opinion – in other words, the applicant cannot bring in new evidence at this stage. The applicant may request that the committee consults a scientific advisory group in connection with the re-examination. https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/evaluation-medicines-step-step

If they can include sub-groupings, comparison to ADNI, etc, then there would seem to a reasonable chance for approval. If not, then approval may be difficult to attain.