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Re: None

Saturday, 05/24/2014 11:41:00 PM

Saturday, May 24, 2014 11:41:00 PM

Post# of 9944
This bothers me: FDA previously communicated concerns regarding the development program and provided advice regarding the type of data that should be systematically collected to investigate the clinical benefit(s) of an intratumoral treatment of a subset of individual lesions in a systemic disease (malignant melanoma), as previously discussed at the April 8, 2010, March 7, 2011, and October 18, 2011, end-of-Phase 2 meetings and the December 16, 2013 General Guidance teleconference.
Did they respond to this in the conference call? It's saying "we told you 5 times."
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