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Biotech / Medical : sciclone pharmaceuticals

SCLN 11.15

0.0%

Oct 20 5:00 PM EST

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To: Guy Gordon who wrote (479)	3/22/2000 3:45:00 PM
From: AurumRabosa	Read Replies (1) of 1137

I don't believe the FDA has approved an NDA for Zadaxin or any other SCLN drug as of yet. They have to successfully complete a Phase III clinical trial and perhaps the FDA will request a Confirmatory Phase III trial as well depending on the trial design and the data. You're absolutely correct that once the FDA has approved a drug for sale in the US for any indication doctors can prescribe it "off-label" for anything they want. This is currently the subject of much debate regarding the abusive use of Ritalin and Prozac prescribed for children 2 to 6 years old. Getting marketing approval for Zadazin for any indication in the US wil be HUGE!!! Orphan Drug Status is granted by the FDA to encourage the development of drugs that treat relatively small markets that might otherwise not attract the attention of Big Pharma. I'm not sure when the 7-year exclusivity clock starts running but I believe it's upon FDA approval of the NDA. Does anyone know for sure?

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