Ryoncil: ODAC/FDA Meeting Discussion, page-524

Okay, it's the end of the 1st quarter...what's everyone thinking?

I think the questions from the panel were actually quite shallow, and that they don't really seem to have as in-depth of knowledge of these issues as one would expect for it to be really helpful to MSB in designing or considering additional tests for CQA improvement.

They were asking questions that, frankly, many of us here could have answered.

My main worry, about the FDA pouring water on MSB's testing of CD105 and CD106 for CQA purposes, was totally defanged by (1) the FDA guy admitting the FDA doesn't even dictate any tests to be used, even if they think that MSB's use of that testing was not effective; and (b) SI making the point, HARD, that they think it's effective, regardless, as demonstrated by consistency in effectiveness in patients, the improvement in outcomes due to modifications based on their tests, and due to the scope of work they have done in far more than just the patients in the three studies, with correlational studies showing that consistency across a much broader range of patients.

All in all, I am feeling really good at this point.