Re: UPDATE 9/16/2011 from Genentech re: TDM1 EAP/TPAS
Is FDA to blame for not responding or does this imply that Genentech's regulatory department really doesn't understand the requirements and is seeking government intervention were none is called for?
FDA's refusal to even look at phase II data that Genentech hoped to get an early T-DM1 approval for clearly shows a major disconnect between these organizations. What terrible way to conduct business.
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