Mandatory Rest Period

Fampridine-SR - Special Protocal Assesment with FDA
2007-05-30 14:08:46

The objective of the study is to show that individuals treated with Fampridine-SR are significantly more likely to have consistent improvements in their walking than those treated with placebo. Pending clinical results, the FDA has agreed that this trial, MS-F204, together with the company's first Phase 3 trial, MS-F203, would be adequate to support a New Drug Application (NDA) for Fampridine-SR. "We are pleased to have reached this agreement with the FDA, and are already working closely with our team of 35 MS centers to begin the study," said Ron Cohen, M.D., President and CEO. "Currently, there are no approved therapies that improve mobility in people with MS and physicians and patients regularly rate walking as one of the areas of greatest unmet medical need for this condition."

- posted by Anonymous @ 10:03 PM - Link @ 10:03 PM - Link to this post - Comments (0)

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	Wednesday, May 30, 2007 Fampridine-SR - Special Protocal Assesment with FDA 2007-05-30 14:08:46 The objective of the study is to show that individuals treated with Fampridine-SR are significantly more likely to have consistent improvements in their walking than those treated with placebo. Pending clinical results, the FDA has agreed that this trial, MS-F204, together with the company's first Phase 3 trial, MS-F203, would be adequate to support a New Drug Application (NDA) for Fampridine-SR. "We are pleased to have reached this agreement with the FDA, and are already working closely with our team of 35 MS centers to begin the study," said Ron Cohen, M.D., President and CEO. "Currently, there are no approved therapies that improve mobility in people with MS and physicians and patients regularly rate walking as one of the areas of greatest unmet medical need for this condition." - posted by Anonymous @ 10:03 PM - Link @ 10:03 PM - Link to this post - Comments (0)