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

To: Andrew H who wrote (10956)	11/10/1997 9:33:00 PM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

Andy, I don't know the details of the new regulations, such as when they go into effect and how they impact existing trials. LGND has been somewhat combining the trials so the Stage II/III lung trial is designed to test a couple of concentrations, but test enough patients to also show efficiency. I think that the new legislation would allow the one Phase II/III trial to be sufficient for approval. For Targretin, I think that LGND is somewhat relying on the new rule. For topical, they announced a pivotal Phase III trial. For oral they did a couple (on different patient populations) of Phase II/III, but the NDA filing date is projected to be similar, so they are planning on just one advanced trial for each indication. The new legislation may help future trials, but LGND seems to have already done a fair amount of streamlining already. They have extensive discussions with the FDA before they start the trial so everyone is on the same page and there are no surprises. LGND of course has been very quick to bring drugs to market. Panretin (9-cis retinoic acid) was discovered in 1992 and it looks like it will be on drugs store shelves in 1998. That is remarkably quick. The new legislation will help a little, but LGND has already found ways to design trials to ensure quick approval.