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Biotech / Medical : Imclone systems (IMCL) -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (1770)	12/31/2001 3:49:03 PM
From: 613	Read Replies (1) \| Respond to of 2515

From IMCLs own PR on rolling BLA: "The rolling BLA mechanism affords us the opportunity to work with the FDA to ensure that all of the information that the Agency requests is included in each section as it is finalized and submitted for review," stated Harlan W. Waksal, M.D., Executive Vice President and Chief Operating Officer of ImClone Systems. "The advantage to submitting the BLA in this manner is that it allows us to receive very directed guidance from the respective FDA reviewers on the content and focus of the BLA during the submission process." I'd like to hear IMCL's spin on this.