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foggdogg

05/06/09 7:39 PM

#88 RE: yessum #87

Yup...that's the ODD news we are waiting for from the FDA. It's due within 60 days of March 10, so ANYDAY now!! Welcome to the board by the way!
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AMA

05/06/09 9:57 PM

#95 RE: yessum #87

By statute, the FDA must review and respond to an Orphan Drug application within sixty (60) days.

The approval time for orphan products is often considerably shorter than the approval time for other drugs. This reduced approval time is due to expedited review or accelerated approval because the drugs treat serious or life-threatening diseases.