Thread: MBP8298 receives fast track designation from FDA
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Old 09-04-2008, 09:44 PM
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Default MBP8298 receives fast track designation from FDA
We talked about this exciting drug opportunity in the following thread:

http://neurotalk.psychcentral.com/thread52769.html

... but the latest news is that it looks like it is getting fast-tracked for drug approval in the US:

Multiple Sclerosis drug dirucotide (MBP8298) receives fast track designation from FDA


BioMS Medical Corp. announced that the Food and Drug Administration (FDA) of the United States has granted fast track designation for the Company's lead drug, dirucotide (MBP8298), for the treatment of secondary progressive MS (SPMS). Dirucotide (MBP8298) is currently being evaluated in a U.S. pivotal phase III trial, named MAESTRO-03, at 68 sites with approximately 510 patients.

Fast track designation is an FDA status reserved for products that are intended to treat a serious or life-threatening condition and that demonstrate the potential to address unmet medical needs for that condition. Fast track designation can potentially facilitate development and expedite the review process.

"Our receipt of fast track designation for dirucotide in the U.S. is a significant milestone for both BioMS Medical and the MS community," said Kevin Giese, President and CEO of BioMS Medical. "Based on previous clinical results, we believe dirucotide is well-positioned to become a first-in-class treatment for secondary progressive MS patients, a large patient population with very limited treatment options."

Source: BioMS Medical Corp. (04/09/08)

http://www.msrc.co.uk/index.cfm?fuse...ow&pageid=1308

Cherie
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