I hope the 008 comes out positive because we don't seem to be getting to much help from the FDA at the moment, from my reading of the document it states "therefore, FDA welcomes efforts to address the above considerations and is open to work with all stakeholders on such programs." I agree would also help hugely in any negotiations. Does anyone know where the 008 is at??
Ann: PARADIGM RECEIVES FEEDBACK FROM US FDA ON IND SUBMISSION, page-170
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