Mesoblast Company Update - Webcast and Forward Thoughts, page-213

https://www.fda.gov/media/87421/download

The FDA's own slide show about ODAC conflicts of interests, at Slide 6, gives this example:

– Example: The sponsor of a new drug application that is being presented to an advisory committee and sponsors of drugs that closely compete with the subject drug would all be "potentially affected organizations" for which the financial interest of the SGE in the organization would need to be considered for potential conflicts of interest.

This no doubt involves Hinrich and I remember looking through the listed conflicts before the start of the meeting and didn't see any declaration from him. Judging from SI and Grossman's tone of voice after the ODAC vote, when trying to identify who the opposing vote was, the inflexion in their voice when saying "Hinrich" indicated contempt, and that they might know about his conflict.

The question is, what can be done about bringing this conflict to FDA's attention and will it do any good? The slide show doesn't state any remedy that I can see but if, as all are thinking, the FDA is sensitive to political pressure, then a formal mechanism isn't necessary. Public embarrassment before the Type A meeting might be sufficient.