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Amyotrophic Lateral Sclerosis
ALS drug candidate Myogane gets U.S. FDA Fast Track designation
December 12th, 2004
Phytopharm plc (NASDAQ:PHYOF)(LSE:PYM) (Phytopharm) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its drug candidate PYM50018 (Myogane) for the treatment of amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease). The Fast Track program is designed to expedite the review of drug candidates for the treatment of patients with serious or life-threatening diseases with unmet medical needs for new therapeutic approaches. The Fast Track designation allows a company to file a New Drug Application (NDA) on a rolling basis as data become available and to request the evaluation of studies using surrogate...
Source: Medical Letter on the CDC & FDA (2004-12-12)
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