We're all anxiously(especially Eli LIlly, Amylin and Alkermes) waiting word from the FDA tommorrow on fate of Byetta LAR the new once a week form of Byetta for the treatment of diabetes. Maureen Martino, Fierce Biotech, describes 4 possible outcomes ranging from approval with a standard warning through the most dire "complete response" letter which would result in a lengthy delay in the drug's approval. Should the worst case scenario occur, be prepared for both Amylin and Alkermes stock to take a plunge. Should the news be good - the companies could be looking at as much as $3 B in sales by 2015.
Bets are the agency will require a minor data submission that will still allow for ultimate approval of the therapy in 2010. So, will it be Hello or Bye-Bye to the new approval?
Posted by Bruce Lehr March 11, 2010