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Friday, 09/23/2011 3:50:31 PM

Friday, September 23, 2011 3:50:31 PM

Post# of 20689
Follow on Biologic companies meeting with FDA

Investorgold, the attached article provides some of the rationale why the progress to announce follow on biologic partnerships has been slow. The majority of the industry appears to be waiting for the FDA guidance to be released. Now that it is close the FDA has been meeting with interested parties. The present climate is simply too risk adverse for companies to make significant investment without having a clearer picture of the regulatory process. I think we can expect the partnership progress to move quicker once the regulatory guidance is finalized. That assumes that the guidance follows the process described in last months NEJM article.

FL
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