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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?

To: aknahow who wrote (6604)	6/29/1998 2:09:00 PM
From: opalapril	Read Replies (1) \| Respond to of 17367

I thought I saw somewhere that orphan status also involves valuable tax breaks and accelerated FDA review. True?

To: aknahow who wrote (6604)	6/30/1998 9:36:00 AM
From: Tharos	Read Replies (1) \| Respond to of 17367

George, Don't forget the tax credit, it could be significant considering the amount of money the company has spent developing Neuprex. From FDA site: Among other provisions for orphan-designated products are: Grants--The act funds a total of $12 million worth of clinical research grants annually. Each grant may cover as much as $200,000 of direct costs per year for up to three years. The grants provision is aimed not at large companies but at smaller, research-oriented organizations. So far, six approved orphan drugs have come from the grants program, and several more are in clearance. Since 1983, FDA has awarded $67 million in research grants (another $12 million is earmarked for fiscal 1995 distribution). *(don't tell ALBUNDYFAN about this next one, he thinks biotechs that design research are cheats ;-)) * Protocol assistance--FDA helps orphan sponsors design research that conforms to regulatory requirements and shows them how to deal with the FDA review system. Sponsors, especially small companies with little regulatory experience, can save time and money using this service. Tax credits--A sponsor may claim 50 percent of clinical trial costs as a credit against taxes owed.