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

To: SecularBull who wrote (1512)	8/18/2005 1:14:52 PM
From: PuddleGlum	Read Replies (2) \| Respond to of 4474

I asked this on another thread... Now that AP23573 has fast track AND orphan drug status what does this mean for the company? With fast track didn't we already have improved access to the FDA to assist with study design? Based on this quote from the release it looks like we have some financial incentives: "Orphan drug designation, which is intended to facilitate drug development, provides substantial potential benefits to the sponsor, including funding for certain clinical studies, study-design assistance, waiver of Prescription Drug User Fee Act (PDUFA) fees, tax credits and up to seven years of market exclusivity for the product upon regulatory approval." Can anyone quantify the financial incentives? Are we talking $50,000 or $1M? What is the impact on time to market?