InvestorsHub Logo
Followers 43
Posts 2488
Boards Moderated 0
Alias Born 10/19/2015

Re: BIOChecker4 post# 383385

Tuesday, 11/15/2022 11:45:32 AM

Tuesday, November 15, 2022 11:45:32 AM

Post# of 461917
I believe Dr. Missling intends to submit the pediatric Rett data first to secure the priority review voucher. Would submitting to the FDA for approval for another indication preclude applying for the voucher if Blarcamesine has already been approved? I don't know. Maybe someone else here does. But that would be one of my several guesses that answers your question.

Another reason is maybe they're still in discussions with the FDA to figure out the best path forward and whether another trial is necessary. Maybe they're waiting for approval in Australia first and will use that to help boost the odds of FDA approval.

It's a good question to ask but I don't think it's appropriate right now to assume that no NDA = bad news or poor management.
Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent AVXL News