the waaaaaaaaaaaaaay best thing I have heard is that CMC meeting is still in October
This means, by absolute definition, that CEO will give a CMC update on November 4 Q3 conference call
as previously stated, I think market is starved for an FDA wink of any kind
info on CMC meeting is such a potential FDA wink
The best thing I've heard so far is that all of Congress and the President might get kicked out of Washington.
Get rid of them ALL. Democrats, Republicans, Tea Party, and Independents. They ALL MUST GO.
I seriously doubt the FDA will show any cards before the availability of the drug is assured. The best we can hope for from the CMC meeting is clarity on flexible stability times. Same goes for AA decision won't happen before drug availability. The good news is it will be approved when the drug is available, they can see it works and is safe and time is of the essence for the kids, Janet Woodcock has stated to the advocates it will be processed as FAST as possible and that means available.
yes they want to make sure that the sufficient drug, i.e. made with final manufacturing process, specs & methods, is available to begin the required prospectively designed FDA blessed phase III trial and passes for NDA approval
READ MY LIPS: No Accelerated approval. GSK set the precedence....
we need that company pr confirming the Q3 call date
various financial sites say 11/4, but we need to see a company announcement to confirm it
our risk of CMC being delayed is now gone
and we also now have the PPMO issue
I continue to think the Q3 call could be quite important across all fronts