Sono le 7 del mattino a New York e mi hanno mandato questa mail. Dato il momento, a dir poco "imbarazzante", ve la giro per vostra conoscenza: Aragingo, this is important, see extract and link: If CDER does not agree that the submission is a complete response addressing all deficiencies in the complete response letter, the applicant will be so informed, and the review clock will not start until a complete response is received.
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm082002.pdf So, we know from the CTIC PR, that the clock was ticking towards the PDUFA date in April. So, CTIC must have submitted a complete response, and the FDA must have accepted that it was a complete response, otherwise the clock would not have started. That being the case, the 'stitch up' or plain issue has flowed from the ODAC request, whatever that was.