Sorry longs. Read the press clip below. The 12-1 was just on the effectiveness. The panel is currently discussing whether the improvement is clinically meaningful and whether the product is safe.
This is why the stock is still halted in after hours. This is not looking goo for longs.
Here is the official news clip:
FDA Panel Says Data Show Proposed Acorda Therapeutics MS Drug Effective-DJ 3:37pm EDT Dow Jones reported that a Food and Drug Administration panel said a proposed Acorda Therapeutics drug to treat multiple-sclerosis appeared to be effective at increasing walking speed. The drug, fampridine-SR, is being reviewed Wednesday by an outside panel of medical experts. The panel voted 12 to 1 in favor of a question that asked if the Company demonstrated substantial evidence of effectiveness of fampridine as a treatment to improve walking in patients with multiple sclerosis. The panel is currently discussing whether the improvement is clinically meaningful and whether the product is safe. Fampridine has been associated with a seizure risk at higher doses than the 10-milligram dose for which Acorda Therapeutics is seeking FDA approval. The FDA said one study of about 300 patients showed that 34.8% of patients receiving fampridine-SR had an improvement in walking speed compared to 8.3% in the placebo group. Patients were timed as part of a 25-foot walking test at different time points during treatment. Another study involving 237 patients showed 42.9% of patients in the fampridine group had an improvement in walking speed compared to 9.3% of patients in the placebo group. But an agency reviewer said the improvement in walking speed is of small magnitude and of uncertain clinical significance.