ImClone (IMCL) Files Supplement BLA To Broaden Use of ERBITUX
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ImClone Systems (NASDAQ: IMCL) submitted an application to the FDA to broaden the use of ERBITUX to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.
The application, submitted on August 29, 2008, was prepared in conjunction with Bristol-Myers Squibb Company (NYSE: BMY), ImClone's partner for ERBITUX in North America. ImClone has requested Priority Review of the application, which, if granted, means that the FDA would make a decision on the application within six months. The FDA will notify ImClone whether it has accepted the submission by the end of October.
NOTE: Bristol-Myers recently offered $60 per share to acquire ImClone, but no deal has been reached yet.
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