alias25 schreef op 13 juni 2013 15:02:
...nd either the “Filing Issues Identified” letter or the “No Filing Issues Identified” letter to the applicant by day-74. A single letter can be used to satisfy both the day-60 and day-74 requirements. The filing communication gives the applicant early notice of any review issues identified to this point. This communication also identifies review timelines (See Planning Meeting section below). The planned review timeline included in the day-74 letter for applications in the PDUFA V “Program” will include the planned date for the internal mid-cycle review meeting and preliminary plans on whether to hold an Advisory Committee (AC) meeting.
Indien maandag geen nieuws, gaan ze eruit en wacht ik tot na 4°tranche en tot 1 juli.