Finally some life in this old dog. Up 82% in the last hour of trading.
BOSTON--(BUSINESS WIRE)--Aug. 15, 2005-- Boston Life Sciences, Inc. (NASDAQ: BLSI - News) announced today that, at the request of the company, the US Food and Drug Administration (FDA) granted a new Special Protocol Assessment (SPA) for ALTROPANE®, the Company's molecular imaging agent that is being developed to aid in the differentiation of Parkinsonian Syndrome (PS) tremor from non-Parkinsonian tremor. Under the terms of this agreement with the FDA, the Company may conduct two smaller Phase III trials, POET-1 and POET-2, rather than one large Phase III trial without sacrificing its SPA status and will be permitted to include all subjects currently enrolled in the existing Phase III clinical trial pursuant to the revised protocol. In addition, the Company has reduced its statistical endpoint threshold from p<0.02 to p<0.05 for both studies.
"Naturally I am delighted with this accomplishment," stated BLSI Chairman Peter Savas. "It's the product of a broader effort on our part to better position our programs and assets for development, approval and commercialization."
The Company's President Dr. Mark Pykett added, "We believe this new agreement with the FDA is beneficial in three ways. First and foremost, we significantly lowered our statistical endpoint requirement from p<0.02 to p<0.05. Second, we retained our SPA status without losing the benefit of the patients that have been enrolled to date. Third, we abbreviated the time and cost of completing the ongoing Phase III study. As a result, we may be in a position to advance partnering opportunities earlier than expected." |
