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Biotech / Medical : Imclone systems (IMCL)

IMCL 0.159

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Oct 5 5:00 PM EST

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To: tuck who wrote (2427)	4/12/2005 4:47:24 PM
From: tuck	Read Replies (2) of 2515

>>NEW YORK--(BUSINESS WIRE)--April 12, 2005--ImClone Systems Incorporated (NASDAQ: IMCL - News) and Bristol-Myers Squibb Company (NYSE: BMY - News) announced today that they intend to file a supplemental Biologics License Application (sBLA) to seek approval of Erbitux® (Cetuximab) for use as a single agent and in combination with radiation in Squamous Cell Carcinoma of the Head and Neck (SCCHN) with the U.S. Food and Drug Administration (FDA) before the end of the year. The Companies had previously announced they intended to submit an sBLA in the second quarter of 2005. The Companies are taking additional time to submit the filing to strengthen the process by which the primary endpoint of Study IMC-9815 (locoregional disease control in the head and neck region) is evaluated by the independent reviewers. The review of the secondary endpoint of the study, survival, and the data from the second pivotal study, EMR-016, are not subject to this independent review process. The Companies remain confident that the filing will be completed with all the data originally expected to be submitted. The process for completing the independent review was submitted to and reviewed by the FDA.<< snip This should create a buying op for those that want one. Cheers, Tuck

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