Ligand (LGND) Breakout! Message Board

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Biotech / Medical : Ligand (LGND) Breakout!

LGND 197.62

+0.1%

Dec 24 12:59 PM EST

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To: celeryroot.com who wrote (26639)	11/20/1998 4:21:00 PM
From: jayhawk969	Read Replies (2) of 32384

Celery, From the press release: The complete review letter received by Seragen fulfills the FDA's commitment under the Prescription Drug User Fee Act to a six-month review of Seragen's BLA for ONTAK, which was designated for priority review. The BLA was submitted on December 9, 1997, and the complete review letter is dated June 9, 1998. Upon issuance of the letter, the review clock is suspended and is not reactivated until all deficiencies have been addressed by Seragen. The letter identified certain deficiencies in the application related to safety, efficacy, manufacturing and product characterization. What is your interpretation? Something is sloing approval. J.D.

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