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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: celeryroot.com who wrote (22565)	6/20/1998 11:30:00 AM
From: WTDEC	Read Replies (1) \| Respond to of 32384

C, do you know how long the FDA has to respond once SRGN/LGND has filed the reply to the Complete Review Letter? W PS: Is USO later today?

To: celeryroot.com who wrote (22565)	6/20/1998 11:53:00 AM
From: Hippieslayer	Read Replies (1) \| Respond to of 32384

You r right. "SCrewed up" is too harsh to use. But, there seemed to be several items that needed clarification. The pr was not specific but it read as if SRGN did not do their homework well enough. Hopefully they are small little glitches that can be easily explained and corrected. Thanks for the clarification and update, Celeryroot.

To: celeryroot.com who wrote (22565)	6/20/1998 12:07:00 PM
From: Machaon	Respond to of 32384

I think that the FDA reacted as any government bureaucracy normally does. It didn't want to seem like it's subcommittee "tail" was shaking the FDA "dog". I'll bet that the FDA chairman's feathers were ruffled by the lack of time that was available, after the subcommittee submitted their very positive recommendation. Instead of reacting aggressively, and accepting the overwhelming approval of the committee, they decided to throw up a normal government roadblock. Another example of why it takes decade(s) to get an effective new drug into production. (If this sounds like anti-"government bureaucracy" hype, it is because it is!) Regards, Bob

To: celeryroot.com who wrote (22565)	6/24/1998 9:11:00 AM
From: Henry Niman	Read Replies (2) \| Respond to 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.