When you do get a meeting with the FDA, or other regulator, it may be more important who you get the meeting with. A meeting with Dr. Padzur's staff may prove a hindrance if they don't check with the good Dr. on what they advise. It's been decades, but I feel certain that Genentech had such a meeting in designing a registrational Phase 2 trial for Kadcyla. When they submitted for approval, Dr. Padzur simply said he didn't like the trial format, and he refused to review their filing. The approval was delayed by years until a Phase 3 trial he agreed with was completed and submitted. I believe that Dr. Padzur was sending a message to his staff as much as to Genentech, don't make commitments without checking with me. It's rather like checking with the IRS, taking their advice then going to tax court and finding it was wrong.
I believe the FDA has improved some in all those decades, but it's still important to get to the right people and reach agreements before making the formal submission, best to wait until that occurs. I certainly don't know what precisely went wrong, but NWBO made the mistake of saying they would submit to the UK by a date certain. After that they backed off twice before actually submitting. They would have been far better off if they hadn't been so precise about when they'd file as credibility was lost when they didn't. Saying you intend to file in a given quarter isn't bad if you believe you'll file early in the quarter, but if it's late in the quarter, better to say the next quarter, and be early. Sure, people really don't like weasel-wording, but it's better than being more precise and failing to meet your commitment.
Gary
