Anavex Life Sciences Corp (AVXL)

[JB3729]

The detailed data AVXL is now compiling could prompt a BTD application -

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.

http://www.fda.gov/ForPatients/Approvals/Fast/ucm405397.htm


Renoit7 Thursday, 11/26/15 03:10:05 PM
Re: Amatuer17 post# 40465
Post # of 63764

I contacted them regarding an application for Breakthrough Therapy Designation and the response I received this morning was:

"The company intends to pursue Breakthrough Therapy Designation and material information will be shared with all investors according to Regulation FD"

My question was if they were planning on applying for BTD and if they would be announcing their application or if they'd wait until the received a response from the FDA to disclose. So I never really got my full question answered, and I'm not even sure what the 'FD' is referring to. Anyone with an experience where BTD was given and if the company announced their application or not?