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


To: scaram(o)uche who wrote (23493)4/18/2007 4:01:39 PM
From: Biomaven  Read Replies (1) | Respond to of 52153
 
Neither Harry nor I are making the argument that you're implying has been made.

I don't disagree - I'm just trying to argue what happens if you take the recent FDA position to its logical conclusion. If you have to demonstrate "superiority" over existing approved drugs then the hurdle is extremely high. Even if the new drug is in fact somewhat better, it is extremely hard to prove it so absent huge trials. That standard would indeed mean that the first few drugs across the finish line would be the only ones approved.

As a concrete example, I don't believe we will ever see another antibiotic approved for acute bacterial sinusitis unless the FDA radically revises their current approach. ABS is responsible for a big chunk of the primary care antibiotic market, and so the incentives to develop new mass-market antibiotics have been markedly reduced.

Peter