InvestorsHub Logo
Followers 4
Posts 589
Boards Moderated 0
Alias Born 03/07/2003

Re: Biobillionair post# 172220

Monday, 01/14/2019 11:54:27 AM

Monday, January 14, 2019 11:54:27 AM

Post# of 426272
That’s a little earlier than possible. Here’s the timeline for tafamidis:

Topline results March 2018
Granted breakthrough therapy designation May 2018
NDA submitted Q4 2018, probably two months ago
Priority review granted January 2019 with PDUFA date six months from then.

I think the end of October 2019 is the earliest we could receive approval unless the FDA acts way outside their box. The end of November is more likely if we submit the NDA at the end of Q1 and receive priority review two months later.
Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent AMRN News