>>BOSTON--(BUSINESS WIRE)--June 16, 2003-- Boston Life Sciences, Inc. (NASDAQ: BLSI - News) announced that it will pursue a Special Protocol Assessment (SPA) filing with the U.S. Food and Drug Administration (FDA) for the Company's radioimaging agent, ALTROPANE®. The Company intends to file the SPA shortly in connection with BLSI's plans to conduct an additional Phase III clinical study in Essential Tremor patients prior to NDA submission, as recommended by the FDA in recent discussions with the Company. According to recent FDA-published guidance, an SPA filing provides for a 45-day review of a Phase III clinical trial protocol. This review forms the basis of an agreement with the Agency regarding the steps to be taken to achieve ultimate approvability of a company's NDA filing.
Dr. Robert J. Rosenthal, CEO and President, stated, "We believe that the filing of an SPA and the conduct of an additional Phase III trial, designed in coordination with the FDA, is in accord with the Agency's input and is therefore prudent and, will place us in a stronger position to secure approval. This trial will be designed to specifically distinguish Benign Essential Tremor (BET) from Parkinsonian tremors, which is an important clinical problem. We recognize that our strategy will delay the filing of the NDA, which we previously indicated would occur by the end of the first half of 2003. However, we have concluded that this course of action represents the best long term strategy to fully maximize the market potential for ALTROPANE® and is, consequently, in the best interests of movement disorder patients and our shareholders." <<
sigh
Cheers, Tuck |
