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Biotech / Medical : Ligand (LGND) Breakout!
LGND 199.34+0.1%3:59 PM EST
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To: celeryroot.com who wrote (22565)6/24/1998 9:11:00 AM
From: Henry Niman  Read Replies (2) of 32384
 
Celeryroot, Bear Stearns issued a report (6/18/98) on the ONTAK letter from the FDA. They also mentioned it in their weekly Biotech Watch. They indicated that such a letter was now standard (approvable and non-approvable letters are no longer issued) and they anticipated a response from SRGN to the FDA in a few weeks. Due to the serious nature of CTCL, they expected a prompt FDA response to SRGN's response.
From the latest Biotech Watch:

REGULATORY WATCH

Ligand (LGND) announced on June 17 that Seragen, a company that LGND has entered into an acquisition
agreement with, had received a Complete Review Letter (CRL) from the FDA regarding the ONTAK Biologics
License Application (BLA). The CRL is now standard procedure for the FDA having replaced the
approvable/non-approvable letter. The letter identified certain deficiencies in the ONTAK application related to
safety, efficacy manufacturing and product characterization. We understand that Seragen anticipates responding
to all of the FDA's questions in a matter of weeks. We anticipate a timely review of the companies responses by
the agency due to the serious nature of the disease for which ONTAK will be indicated (advanced cutaneous T-cell
lymphoma). Bear Stearns acted as an advisor for LGND in its purchase of Seragen.
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