Conflict of Interest Evidence Thread - C. Hinrichs in ODAC Meeting, page-35

bedger,

I agree that we need to be circumspect here. We need to consider what harm vs good this action will take, and because we're not privy to what next steps the MSB executive are considering, or what exactly was behind the FDA decision (beyond what they publically announced), our consideration will be based somewhat on assumptions - not a strong position for decision making.

With so much money being involved, I don't think common sense always takes centre stage when it comes to FDA decisions. Results are important, but so are policy, decision making frameworks, advocacy, influence, political pressure and leverage (as we have been so harshly reminded). The fact that this same product has been, and continues to be used sucessfully in Japan, to me, says it all.

Say we do get to the point where this jounalist publishes a piece about Hinrichs' alleged conflict of interest and it's possible impact on the FDA decision; I'm pretty sure the FDA won't take kindly to the article. Whether that matters or not, I don't know. It's possible they may dig their heels in further. It's also possible that they won't even blink given that they hold most of the decision making levers. Even if they do blink, how long will it take for anything poositive to come out of the publication of the article? We also need to consider what impact such a publication may have on how Mesoblast's upcoming trial results are interpreted by the FDA.

There are no words for how I truly feel about Hinrichs and the recent FDA decision. As infuriating as Hinrichs' and the FDA's contributions are, my view is that we should hold off, at the very least, till we know for certain what the Mesoblast executive next steps are.

I do think Hinrichs' alleged conflict of interest should be investigated. I am just not certain that right now is the time to do it.