Anavex Life Sciences Corp (AVXL): At the 13:45 mark of the Needham Confere...

Reply Private New

Replies (2) Next 10 Prev Next

Send PM Follow Ignore

Followers	44
Posts	4966
Boards Moderated	0
Alias Born	04/30/2005

abew4me

Re: None

Thursday, 03/17/2022 7:13:34 PM

Thursday, March 17, 2022 7:13:34 PM

At the 13:45 mark of the Needham Conference: When will be the estimated time to file for the Rett Syndrome indication and when do you plan to meet with the FDA to discuss the data that's been generated so far?

ANSWER: "So we stated that we'd like to meet now. We just need to put together the clinical study report of the AVATAR Study. We already submitted the (RS-001) study report of the data report for the U.S. study. And after all that has been received, we will have the meeting.

And then we will discuss with the agency if the two adult studies together are sufficient for an NDA filing or if the 3rd (pediatric) study would need to be added for the entire age group."

16:03 mark...TGD continues: "On top of that, we have other indications where we have studies going back over five years with the drug in Alzheimer's Disease and other ongoing/extension studies in Parkinson's Disease for example. So, altogether we have a very good long-term safety package, we believe, and that's why we are confident that we will not need additional studies at this point."