I can understand your concern, but since the draft guidelines were out before the pre-NDA meeting, it seems like the adequacy of our cardio study is certainly a topic that would have been discussed. After all, the FDA had no problem telling us to go do a bio-equivalency study prior to filing. If they thought we needed to do a bigger cardio study, why wouldn't they have said so at the meeting?
That is an excellent point. It serves to reduce my concern greatly. It seems the FDA can be a very political entitiy and will 99 out of 100 choose the path of least risk to themselves, even if it gives the appearance of flip-flopping on issues that can mean life and death for a company or the patients they seek to cure.