Ligand (LGND) Breakout! Message Board

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Biotech / Medical : Ligand (LGND) Breakout!

LGND 201.29

+0.2%

3:59 PM EST

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To: Hippieslayer who wrote (22392)	6/17/1998 5:48:00 PM
From: WTDEC	Read Replies (3) of 32384

'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. ''We are pleased with the timeliness of the FDA's review of our application,'' said Seragen's president and chief technology officer, Jean Nichols, Ph.D. ''We look forward to continuing to work closely with the agency to address the issues outlined in the letter.'' ' Sounds like a serious delay to me. Henry, any sense of what this is all about?

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