Replies to post #113791 on Biotech Values

[DewDiligence]

Brilinta new PDUFA date is 7/20/11:

http://finance.yahoo.com/news/US-FDA-Assigns-New-PDUFA-Date-bw-3158711424.html?x=0&.v=1

[jessellivermore]

The most notorious FDA reveral was in 1992. The FDA's convenened expert panel..no plastic surgeons..voted to keep the silicone gel breast implants on the market. David Kessler the then head of the FDA unilaterally decided to put a moratorium on gel implants which restricted 90% of their use. Kessler's reasoning was based on his notion of risk-benefit. He set the benefit for breast implants at zero...

This action set some one plus women who had been previously implant into a frenzy of worry, triggered a $4 billion settlement against gel manufacturer Dow Corning, put all but two of the fifteen or so implant makers out of business, and raised the cost of gel implants from $200/pair to $2000/pair...

":>) JL

[DewDiligence]

Cases Where FDA Rejected a Drug Endorsed by Advisory Panel

[Fixed Belatacept and Brilinta entries to show belated approvals.]

 
                        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       apprvd 07/11  #msg-65396139 
 BMY      Belatacept       13-5         5/10       apprvd 06/11  #msg-64295530 
 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.