FWIW: here is my handicapping of the Erbitux review: 1. Approval: 68% --1a) Unconditional approval: 26% --1b) Approval restricted to contract manufacturer (no use of in-house plant): 42% 2. Approvable letter: 18% --2a) More clinical work needed: 11% --2b) Issues can be resolved without more clinical work: 7% 3. FDA requests an extension: 13% 4. Rejection: 1%