Conflict of Interest Evidence Thread - C. Hinrichs in ODAC Meeting, page-40

I'm not much into the conspiracy theory of a master plan of Hinrichs to make his fortune from his patent.

The main issue was he showed a fair level of lacking in scientific and data driven rigor by ignoring the Kaplan-meier curves from the second RCT which showed a clear difference in outcomes between old and new products which MSB further demonstrated potency measurements to back up these outcomes as well as backing up their proposed MOA. Instead of observing and commenting on this data he outright refused accept it and in a very unprofessional manner mocked MSB's change in manufacturing processes which would have taken years of development by stating "So do we think that these tweaks to the manufacturing have only made it highly effective..". There were other comments in that tone as well throughout the meeting by Hinrichs.

He was a lone voice on the panel in the end when it came to decision on efficacy demonstrated by the data, most likely because he clearly refused to review some of the data presented to him, based on his comments in the meeting. Unfortunately, FDA themselves were not keen to approve based on their pre-meeting notes. They definitely expected a negative vote and were probably extremely surprised they got a 9-1 vote. With Hinrich backing their additional RCT, I truly believe that one vote may have provided the small wiggle room they had left to not be left in an untenable position of a 10-0 vote and thus ignoring the committee altogether. The one dissenting vote may not sound like much but it only takes jury member in a court case to block a decision (well, at least that used to be the case).

Even with the 9-1 vote, it is a historic decision by the FDA. Never have they voted against a 90%+ positive vote. This will go down as a case study, no doubt, in many regulatory and legal courses. There was some antagonistic behavior between FDA and some members of ODAC. Not sure how these panels will go from here if FDA doesn't value these experts opinions, especially in cases of overwhelmingly clear cut responses to FDA questions.