Biotech Values

[DewDiligence]

Cases Where FDA Rejected a Drug Endorsed by Advisory Panel

[Added ITMN’s pirfenidone. Note: this
table does not purport to be exhaustive.]

 
                       Panel Vote   Date of FDA    Ultimate     iHub  
 Company    Drug      For Approval  Non-approval   Resolution   Reference 
 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 
 PFE     Oporia†           9-3         1/09         pending     #msg-34890112 
 Roche   Actemra          10-1        12/08       apprvd 01/10  #msg-33965815 
  
 *a/k/a sugammadex. 
 †a/k/a lasofoxifene.