MSB to dispute FDA finding in Type A meeting, page-429

Excellent points @bedger
Speaking generally, I'd like to add that MSB has consulted very closely with the FDA throughout the lengthy process of having this revolutionary MSC process, approved. (not being. a you know what....pharmaceutical drug where they had prior experience... ).

SI has had a consultant role with the FDA as they flushed out the rogue stem cell operators.
Also Teva (previous Cephalon employees) had been instrumental with MSB (as our then partner) in developing the first clinical trials protocols for stem cells, as MSB is the pioneer.

We've done all this and the delays involved have been considerable as the FDA slowly adjusted to this new paradigm.
It's been going on for freaking YEARS. It's been PAINFULLY slow.

Accelerated path? The FDA had that option from looking at what was done in Japan.

We already have fast tracking of a sort, in the sense that stage 1 is pretty much obsolete and we get to go straight to stage 2/3 with stem cells? Then they reduced the amount of patients needed for a clinical trial, because safety to the patient is not the big issue that it was thought to have been in other applications not just this one. All good.

MSB was taking the slow but steady approach and holding the hand of the FDA through the entire freaking thing, consulting away. You'd think it would count for something with unmet need but no!

I's bizarre that the FDA is bunging this on at this late stage. I do not think the fault lies with MSB strategy. That's putting it mildly.