Accentia, Inc. Announces Investigational New Drug Application for Revimmune Usage in a Pivotal Phase 3 Study of Refractory Multiple Sclerosis
10/8/2007 8:09:34 AM
TAMPA, Fla.--(BUSINESS WIRE)--Accentia Biopharmaceuticals (NASDAQ: ABPI) announces that it met with the Food and Drug Administration (FDA) on September 26, 2007 for a scheduled pre-Investigational New Drug (pre-IND) meeting on Revimmune™. The FDA has indicated its support for Accentia to submit an IND for a pivotal Phase 3 randomized controlled, multi-center clinical trial of Revimmune, the company’s potential therapeutic for refractory, relapsing-remitting Multiple Sclerosis (MS). The FDA indicated that they support the proposed submission from Accentia and that they are in overall agreement with the proposed design of the Accentia clinical program.
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