Ryoncil: ODAC/FDA Meeting Discussion, page-1989

agree and I think that is what scared a lot of people when they first read the FDA briefing document... it really sounded like the FDA was disagreeing with everything ... but those who took the time (it took me a full day and night to properly to go through it all and form my own conclusion), were able to look at the bigger picture and put it all in context and draw their own conclusion.

after doing that I felt very comfortable and what looked like disagreement was actually the FDA just saying they don’t understand and that they need a lot more clinical data before they can be convinced... hence the fact another trial was inevitable... they really want more data too.

The FDA places little weight on data generated outside of a clinical trial.. which is probably why the Japan data never showed up... different geographical location and not a clinical trial ... they want more trials and MSB will deliver ... but only after they get the product approved!