Conflict of Interest Evidence Thread - C. Hinrichs in ODAC Meeting, page-30

I also don't necessarily agree with the AFR article which claims the one dissenting vote swayed the FDA. However, for an industry 'expert' to put this on the public record, I have re-considered this possibility. Everyone on ODAC had their area of specialty and the FDA and other panel members would look to that person for guidance in their area. Hinrichs was extremely negative and almost mocking of MSB's improved manufacturing process even though MSB demonstrated clear potency differences and outcomes between the old and new processes (even within the RCT).

The FDA may have hung their hat on his vote as he clearly called for another RCT and even stated he found the previous two RCTs overwhelmingly negative. This assertion was not supported by the data which demonstrated a clear separation in the Kaplan-meier curves between the old and new product within the two RCTs.

FDA were keen to not approve the Ryoncil based on the ODAC notes. Hinrichs vote and commentary was the only justification they could possible use for voting against expert panel and to even dare to bring up efficacy again in the CRL given that is exact the question they voted on.

Not sure backing FDA into a corner publicly would be wise re Hinrichs as it will only force them to justify their position on the technicalities (which they have the grounds to do). However, I soft word spoken by MSB lawyers to the next level up in chain of command may be just the tonic to push through an Accelerated Approval. So given MSB ppl have now been made aware of this, I do not recommend any further public/twitter/journo involvement until after the Type A meeting.