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

To: Machaon who wrote (21525)	5/28/1998 6:43:00 PM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

Bob, Having an approved product goes a long way toward speeding up subsequent trials. The purpose of Phase I trials is to test safety. Phase II is to determine the optimal concentration. Phase III is to prove that the drug is effective and safe. Use of an approved product by patients goes a long way toward proving safety. After approval, most of the effort is on efficacy for new target populations. LGND traditionally has done small trials to identify appropriate target populations. When products are approved, they can be expanded into new populations before Phase III trial are completed (through off label use) and Phase III trials can go quicker.

To: Machaon who wrote (21525)	5/28/1998 8:59:00 PM
From: Torben Noerup Nielsen	Read Replies (1) \| Respond to of 32384

>I realize that they don't have to do Phase I, but can they go >directly to Phase III? And, as you indicated, can they do the >testing on a small number of participants? It was my understanding that if Panretin is approved for KS, all they have to do in order to advertise use for other indications is to ''show" that it is effective against those indications by publishing studies (2 papers or something like that). Seems it was pretty simple anyway. And as long as Ligand doesn't advertise Panretin for other indications, I was under the impression that doctor's didn't need any further permissions from anyone to prescribe the drug for other diseases. Isn't that correct? A few small studies against various skin cancers ought to do it... Cheers, Torben