Can we be confident that the quality and reliability of the...

Can we be confident that the quality and reliability of the information and undertakings that PR gives to the FDA really are a on a different level to that he has given shareholders over the last few years? That is in his relationship with the FDA, PR does everything he undertakes to do, is efficient and never misses a deadline, is always transparent about the reliability of all information and promptly communicates anything that might vary from expectations.

If he informs the FDA to the same standards as shareholders then I'd expect the FDA to trust nothing and triple-cross-check everything. This will take a long time and the Fast Track designation will mean very little.