but but but Maz, he was brought in as THE fda expert before the CRL. How in the world did this happen considering the WORLD CLASS ALLSTAR TEAM that elite has assembled. I mean I was distraught when Camargo apparently got the P# issue wrong but I was reassured when the legal whiz kid Pfiffer was brought on board.
Maz The first discussions will be by Phone with key $ELTP members present on a CC talking to the FDA. As NH said yesterday $ELTP will find out exactly from the FDA "what additional info will resolved FDA Tmax concerns".
Without a doubt $ELTP will have all of the 163 Person P3 data which had ZERO safety events with 30 mg SequestOx and this will be discussed at length.