Biotech Values

[DewDiligence]

Feedback from the FDA: this is how the SPA process is supposed to work:

[IMHO: any company that proceeds to a pivotal trial *without* securing an FDA is either out to lunch or not acting in shareholders’ interests.]

http://biz.yahoo.com/bw/040217/175677_1.html

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Boston Life Sciences Receives Further Guidance From FDA on Its Special Protocol Assessment for Phase III Altropane Study

Company in Discussions With FDA to Obtain Formal SPA Agreement Without Necessitating Additional Full Protocol Submission

BOSTON--(BUSINESS WIRE)--Feb. 17, 2004-- Boston Life Sciences, Inc. (NASDAQ: BLSI - News) announced that the Company has received the FDA's response to its latest special protocol assessment (SPA) submission for Altropane for the indication of differentiating Parkinsonian from non-Parkinsonian syndromes in patients with tremors. The FDA requested further modification to the statistical presentation section of the protocol relating to statistical methodologies. The Agency also provided statistical guidance regarding the circumstances under which this single Phase III study would be sufficient to achieve approvability for this indication, and the Company is further seeking clarification on this point.
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"The requested changes to the statistical plan have been made, and a conference call with the FDA to resolve any remaining ambiguities has been scheduled," stated Marc Lanser, MD, President of BLSI. "Based on the feedback from the Agency, we currently believe that an additional full protocol submission will not be necessary in order to secure an SPA Agreement with the Agency, but no absolute assurances can be made until final agreement is reached with the Agency. In any case, we will continue to respond positively and quickly to requested modifications to the SPA protocol, since we believe that concluding a formal SPA agreement is important to the timely success of Altropane and to the Company," added Dr. Lanser.
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