The Clock Starts Ticking Again
The Bydureon three musketeers – Amylin (NASDAQ:AMLN), Lilly (NYSE:LLY) and Alkermes (NASDAQ:ALKS) – received word today from the FDA that the PUDFA date is set for January 28, 2012. According to a company issued press release; “. The FDA has categorized it as a Class 2 resubmission requiring up to six months for review and assigned a new Prescription Drug User Fee Act (PDUFA) action date of January 28, 2012. BYDUREON is an investigational medication for type 2 diabetes.”
Now before everyone starts jumping for joy and dancing in the streets there are a few things to keep in mind. Most notably, this is not the first time Bydureon has had a PUDFA. Next, while Diabetic Investor is pleased to this was classified as a Class 2 resubmission; this is still after the FDA where anything can and usually does happen. Third, while Diabetic Investor expects the FDA to do what they should have done the last time Bydureon had a PUDFA, a clean approval does not solve the legal issues between Amylin and their so-called partner Lilly.
Still this is good news for Amylin, Lilly, Alkermes and millions of patients who would see a vast improvement in their diabetes management with Bydureon. Let’s just hope the FDA has seen the light, has all the data they need and actually follows the scientific evidence.