Anavex Life Sciences Corp (AVXL)

[Steady_T]

What Andrew means is that a request for Breakthrough Therapy designation has to be acted on in 60 days.
Breakthrough Therapy designation confers Fast Track benefits on the drug.

So it looks like Anavex is applying for Fast Track for AD. Rett already has that designation so it makes no sense that it should be for Rett.

A drug that receives Breakthrough Therapy designation is eligible for the following:

All Fast Track designation features
Intensive guidance on an efficient drug development program, beginning as early as Phase 1
Organizational commitment involving senior managers
Breakthrough Therapy designation is requested by the drug company. If a sponsor has not requested breakthrough therapy designation, FDA may suggest that the sponsor consider submitting a request if: (1) after reviewing submitted data and information (including preliminary clinical evidence), the Agency thinks the drug development program may meet the criteria for Breakthrough Therapy designation and (2) the remaining drug development program can benefit from the designation.

Ideally, a Breakthrough Therapy designation request should be received by FDA no later than the end-of-phase-2 meetings if any of the features of the designation are to be obtained. Because the primary intent of Breakthrough Therapy designation is to develop evidence needed to support approval as efficiently as possible, FDA does not anticipate that Breakthrough Therapy designation requests will be made after the submission of an original BLA or NDA or a supplement. FDA will respond to Breakthrough Therapy designation requests within sixty days of receipt of the request.

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy