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

To: Mudcat who wrote (24765)	8/19/1998 8:09:00 AM
From: tonyt	Respond to of 32384

>Henry you forgot to address the apparent 3 month slip in ONTAK approval. Wasn't this approval supposed to be a 'slam dunk'?

To: Mudcat who wrote (24765)	8/19/1998 8:31:00 AM
From: Henry Niman	Respond to of 32384

The slippage in ONTAK approval is hard to define. Before the meeting, one of the analysts (BARS?) was predicting a 3Q approval and 4Q launch, which of course is still possible. However, it seems that Bear Stearns is guessing a 4Q approval. I'm not sure if they previously set a very hard approval date. In the current re-itererated BUY, they state that "..Ligand has responded to the FDA's requests relating to ONTAK, and the product still appears to be on schedule.... Each analyst has a slightly different outlook. For instance, Bear Stearns projected a 2Q loss of $0.42 which was the closest to the actual loss of $0.45. Thus, Bear Stearns may have more accurate projections, and at this time they are not characterizing the ONTAK approval as delayed. It is not unusual for final approvals by the FDA to take a bit longer than projected. The application was being handled by SRGN and I'm not sure how much FDA experience the team had. I believe that prior to the Aug 12 approval of the SRGN acquisition, there was a transition team in place, but I'm not sure who did what with regard to the ONTAK approval. At this point, Bear Stearns has not changed it's $0.09 gain for 1999, so they have not indicated any effect on 1999 sales. As far as the factors affecting the delay (past the 6 month deadline), I put them in the administrative category because the advisory committee voted 14-0 for approval. Thus, they found that the drug was safe and efficacious for the target population (advanced CTCL patients). Since approval was not granted within the 6 month period, I put the delay into the "administrative" category (a vote of 14-0 on the science is pretty definitive). Administrative delays can cover many aspects regarding labeling, manufacturing, reporting, etc. I'm sure that a quick approval is at the top of LGND's list. However, I'm sure that the list is long, and other FDA matters, such as approval of Topical Panretin is also up there. Thus, the length of the delay is dependent on the nature of the concerns, LGND's resources, and the FDA's resources (and their clock is NOT ticking).