Anavex Life Sciences Corp (AVXL)

[OFP]

A P2/3 trial, as I understand it, is an adaptive trial that transitions from it's P2 to P3 stage on some defined trigger.

So far mostly in oncology, hence Anavex to be first with a modern precision medicine trial design in CNS.

A well designed adaptive trial would be great however, don't forget AVXL called their P2a trial adaptive as well...seems like they are using the buzzword more than the methods so far.



@sliceanddice - Sarepta was a very different situation on many facets (population, rare disease, difficulty of doing a new trial, and more). A new trial would have been devastating for Sarepta and the DMD boys...despite that many still consider approval to have been a huge blunder. AVXL does not begin to recreate the conditions that enabled that approval. Given that millions of frail elderly could take it if approved, they will require safety data in 1000s and multiple placebo controlled trials.