The FDA has changed its mind before on drug approvals & timelines | ACAD Message Board Posts

ACADIA Pharmaceuticals Inc.

  ACAD website

ACAD   /  Message Board  /  Read Message

 

 






Keyword
Subject
Between
and
Rec'd By
Authored By
Minimum Recs
  
Previous Message  Next Message   Post Message   Post a Reply return to message boardtop of board
Msg  16886 of 16947  at  8/1/2020 2:55:32 AM  by

good_investor93

The following message was updated on 8/1/2020 2:56:03 AM.

 In response to msg 16885 by  sphericalkutz
view thread

Re: The FDA has changed its mind before on drug approvals & timelines

Kutz,
Your point about the meaning of a CRL is well taken.

The market treated the CRL as though it were a big deal: the day after SRPT's press release (Aug. 20), the stock closed $18 lower and managed to lose another $30 over the next month. When news broke that the FDA approved Vyondys 53, the stock closed over $31 higher. 

Here's a recap of the case for anyone interested:

-- Feb. 14, 2019: FDA accepts Vyondys 53 (golodirsen) NDA with priority review. A "regulatory action date" was set for August 19.
 
-- Aug. 19, 2019: Sarepta receives CRL. At issue: "the risk of infections related to intravenous infusion ports and renal toxicity seen in pre-clinical models of golodirsen."
 
-- Dec. 12, 2019: FDA accepts Vyondys 53

I have not mentioned another strange FDA case: that involving Sarepta's first approved drug, eteplirsen. The Advisory Committee voted down the drug; a public outcry ensued, and then Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, ignored the AdCom's recommendation (which isn't common). I followed this case back in 2015. A good recap can be found on Wikipedia under "history". 
 


     e-mail to a friend      printer-friendly     add to library      
| More
Recs: 2     Views: 211
Previous Message  Next Message   Post Message   Post a Reply return to message boardtop of board






Financial Market Data provided by
.


Loading...