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Biotech / Medical : VD's Model Portfolio & Discussion Thread
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To: Vector1 who wrote (5960)11/17/1998 9:29:00 AM
From: Biomaven  Read Replies (1) 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
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