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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Robohogs who wrote (23499)	4/19/2007 10:49:04 AM
From: Biomaven	Respond to of 52153

On ABS, the FDA has now decided that you have to do a superiority trial rather than a non-inferiority trial. Their rationale was that there is uncertainty about how well the existing antibiotics work and so there is a (remote in my view) statistical chance that the new drug is not provably effective even if it is proven non-inferior to an existing approved drug. It's hard (but not impossible) to do a placebo-controlled trial in this indication because the trials are somewhat nasty, as the FDA requires a sinus punch to enable a bacteriological analysis. In Factive's case this decision was also colored by the FDA's concerns about the rash incidence given that there are some 25 million cases of ABS treated with antibiotics annually. From a pragmatic viewpoint it is not unreasonable that you holistically examine safety, efficacy, and medical need in the context of existing approved drugs when considering a new drug. But it does become unfair when the standard for new drugs is much higher than the standard for old ones, as is the case here. Peter