Anavex Life Sciences Corp (AVXL)

[micky6474]

Per EMA's rule, new datasets could not be introduced in the re-examination.

By contrast, lecanemab (Eisai/Biogen) secured a positive CHMP opinion on re-examination by reframing analyses within the existing dataset (e.g., restricting to certain ApoE4 genotypes and providing additional analyses derived from the main study), still without adding post-opinion new external data.

With this in mind, what would Avavex do to get through for the approval?

Shouldn't they start looking for partnership from larger Pharma and get their trial and data in the right shape after several failures?