As good as Byetta and Victoza are, they still aren't as conenvient as taking an oral pill once a day. That's why Bydureon will be a whole different story. Once a Week dosing with comparable benefits and lower side effects will be unmatched in the Type II market and will make Bydureon a super blockbuster drug.
I think the deal applies also to India a huge market China and every where else.... that if applied will beat US revenues and we get a "royalty" which no one is clear about.
We know the GLP market is currently about 65K scripts in the US.Byetta had a big lead on competitors and lost it.If I seem hard on management,I am,because like you I see a incompetence.Eastborne called it years ago but had to bail.Eastbornes CEO was byetta user.
The EU didn't wait for the FDA when it came to approving Victoza. Whereby the FDA was caught up 0n thyroid cancer risk with Victoza, the EU went ahead and approved the drug on the expected due date. No dealy....
I agree kevin,Novo has successfully done what Amylin management has consistently failed to do... Novo walks into the FDA with a drug that causes tumors in rats at very low doses and gets an approval.Sure I hope for an approval but it was Lilly that picked the wrong dose to do the skewed Bydureon vs Victozia trial.
Also keep in mind as I have posted before, Europe's CHMP Division just completed reviews for Byetta las year for combination use with TZD's which was approved and for a Pediatric Investigation Plan which also approved. The PIP plan included a study do be done for Bydureon. Europe hasn't indicated at all over the years that have a problem with the Exenatide Compound and I hope that will continue with Bydureon.