Will the FDA refuse approval in the face of the favourable ODAC 9 versus 1 vote?, page-29

Chopper - one thing which strikes me about the approval is - this is the first stem cell treatment for the US - and the FDA already stated via ODAC, the bar that MSB meets is the bar that every other company to follow, is going to have to high jump over.

So, I'm thinking:

1) They are going to want to get an FDA approved product out there, given the FDA unapproved stemcell clinics already in existence throughout the US, to maintain their actual control over this new area of medicine - particularly when you're dealing with them being under a hot (and I think pretty deserved, from what I've read) spotlight re their level of benefit as an agency, to the American public. But regardless - they're going to want a product out there and approved, so they can say to everyone else "we have done it, we've not blocking, we're just saying this is the rigorous path you must follow for approval"
2) They will take their time with the MSB approval (which I think they will, apart from benefit questions, for the establish a pathway reason above) - ie: may be to end of the month - simply because it is precendent-setting. Everyone else will then have to walk that path behind MSB, so they want to make its clear, solidly built, well signposted, with all risks addressed and requirements for progression and monitoring in place.

So for the reason of Legitmacy (as well as Benefit) - I think it will be approved. But for the reason of Standard-Setting - I think they'll probably take until the end of the month to do it.

Hopefully, I'm wrong.