Replies to post #1157 on Biotech Values

[10nisman]

Dew,

What's your take on valuation for IMCL? Do you see it as a good buy?

[DewDiligence]

Re: Erbitux manufacturing:

From IMCL’s PR:

http://biz.yahoo.com/bw/040212/125754_1.html

>>
ImClone Systems has withdrawn its [Branchburg] manufacturing facility (BB36) from the Chemistry, Manufacturing and Controls (CMC) section of its Biologics License Application (BLA) and submitted today a CMC supplemental BLA for licensure of the facility. Based on Prescription Drug User Fee Act (PDUFA) guidelines, the FDA has four months from the submission date to take action on the CMC supplemental BLA filing. The withdrawal and resubmission followed a request from the FDA for information on a larger group of patients treated with drug supplied from BB36 to confirm previously submitted safety data from that facility. This information has been collected from the Company's Phase II ERBITUX single agent study of patients with EGFR-expressing refractory metastatic colorectal cancer (IMCL-0144). The CMC supplemental BLA includes the previously withdrawn BB36 CMC section, as well as information on the larger group of patients. Subject to licensure of BB36 within the PDUFA timetable, ImClone Systems and Bristol-Myers Squibb believe they can meet full commercial demand for ERBITUX on an ongoing basis.
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