Mark your calendar, 1/28/2012, and for physicians, 1/30/2012 to be deluged by reps

Interesting news for the FDA watcher crowd today when AZ and BMS announced that the FDA had extended the action date for their SGLT-2 by three months to January 28, 2011.

So will another review / data cut of the phase III’s diffuse the cancer issue so prominently discussed at the advisory panel meeting this summer?

Or is this the agency saying, “knock yourself out, try to prove there is less cancer by torturing your data, but it doesn’t matter as we have already made up our minds”

It will be an interesting week in late January, as the Bydureon PDUFA is at the same time.  It would be a huge step forward, and likely unprecedented to have two diabetes treatment approvals in the same week.

So if you are a physician, I would be both excited to have new tools, at the same time bracing for your favorite reps to be bounding through the office “Good News! we are approved!, but due to managed care, patients won’t have access for months, particularly in Part D, which might take a really long time. oh what’s that doctor, 2/3rds of your patients are covered by Part D?  Oh well, sorry about that.  Can you sign for these samples of this old drug that is pouring out of your sample closet already?  Doctor, Doctor, come back here, please!!!!!”




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