Replies to post #113764 on Biotech Values

[mcbio]

Another case where the FDA overruled its advisory panel, which voted that a CV trial can be done post rather than pre-approval.
Quote:
--------------------------------------------------------------------------------
...a randomized, double-blind, placebo-controlled trial of sufficient size and duration
--------------------------------------------------------------------------------

Sounds like a big and long one.

If it's deemed feasible, is it expected that Takeda would fund such a trial entirely or will OREX be responsible to some degree?

[DewDiligence]

#msg-57528488 :- )

[JJM760]

How is it that the Contrave denial and "bad" CRL is bad news for VVUS and good news for ARNA? Any thoughts?

[DewDiligence]

Cases Where FDA Rejected a Drug Endorsed by Advisory Panel

[Added entry for Contrave. Note: this
table does not purport to be exhaustive.]

 
                        Panel Vote   Date of FDA    Ultimate     iHub  
 Company    Drug       For Approval  Non-approval   Resolution   Reference 
 AMGN     Prolia           15-0‡       10/09       apprvd 06/10  #msg-50796707 
 AZN      Brilinta          7-1         7/10         pending     #msg-57939117 
 BMY      Belatacept       13-5         5/10         pending     #msg-49686117 
 DNDN     Provenge         13-4         5/07       apprvd 05/10  #msg-19483904 
 ITMN     Pirfenidone       9-3         5/10         pending     #msg-49777513 
 MRK      Bridion          14-0         8/08         pending     #msg-31141155 
 OREX     Contrave         13-7         2/11         ?           #msg-59389692 
 PFE      Oporia            9-3         1/09         pending     #msg-34890112 
 Roche    Actemra          10-1        12/08       apprvd 01/10  #msg-33965815 
  
 ‡15-0 vote was for treatment of postmenopausal osteoporosis; 
 vote on prevention of postmenopausal osteoporosis was 12-3.