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Biotech / Medical : Isotechnika
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To: teevee who wrote (53)5/22/2003 10:57:09 PM
From: Biomaven  Read Replies (2) of 285
 
teevee,

Well I went back and looked at the FDA guidance on fast track.

fda.gov

Basically the new drug has to treat a serious condition (this does) and meet an unmet medical need. It turns out that avoiding a serious side effect may in fact qualify:

iv. Ability to provide benefit(s) similar to those of alternatives while avoiding serious toxicity that is present in existing therapies, or avoiding less serious toxicity that is common and causes discontinuation of treatment of a serious disease.

So I guess I withdraw my earlier statement that this would likely not qualify for fast track. If they can convincingly demonstrate substantially less toxicity than cyclosporine then it looks like they would indeed have a shot.

Of course fast track status is not a magic bullet - some drugs that qualify for fast track never get approval as a drug or even make it to an NDA. In general companies (especially smaller ones) make too big a deal of fast track status.

Peter
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