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Re: mskatiescarletohara post# 80

Wednesday, 02/11/2004 7:30:33 PM

Wednesday, February 11, 2004 7:30:33 PM

Post# of 347009
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%


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