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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: Vector1 who wrote (5960)	11/17/1998 12:32:00 AM
From: aknahow	Respond to of 9719

The short answer is, yes. The long answer, is a question. Does anyone know if it is common for any of the FDA panelist to have the specific disease a drug is designed to treat? While shareholders might think that was great, it would seem to introduce bias into the review process. If I had a specific disease why would anyone think I would not see the data presented from my own very special personal perspective? Most of us can do that without any disease. I do assume that the FDA is not adding people to a panel that do not have a scientific or medical background, but rather just as representatives of of a particular illness. But, I can see where a certain line of thinking might insist an activist for any specific disease must be included in the review process even lacking the other standard qualifications. Tell me this is not so!

To: Vector1 who wrote (5960)	11/17/1998 12:51:00 AM
From: Andrew H	Respond to of 9719

I thought it was quite strange. If the panel did not think LGND's results were accurate, why pass the drug by an 8-1 vote. I agree that analysis by photo is a very inferior method, certainly not "scientific." The panel also criticized LGND for not using the same methodology in both trials. What bothered me was that I felt the overall tone of the article was less than positive. I agree that the important thing is that approval is basically assured. However, the market seemed less than pleased.

To: Vector1 who wrote (5960)	11/17/1998 9:29:00 AM
From: Biomaven	Read Replies (1) \| Respond to of 9719

VI, My understanding of what happened with Panretin was that the FDA, after the trial was completed, unilaterally changed the criteria for defining a response. The old definition, which was in the FDA-approved protocol, was based on a 50% decrease in lesion size and/or complete flattening of half the lesions. The new FDA definition, called "beneficial response" was based on a 50% improvement in in appearance and skin reaction in at least half the lesions, maintained for at least 4 weeks. So it's not that the FDA didn't trust Ligand, it's just that they moved the goalposts after the final whistle, and then used a photographic replay to decide how many goals were hypothetically scored <G>. Peter