The people who are dealing with the FDA are the same ones that have failed over and over againfor a decade.
If the same reg team are still the ones negotiating with the FDA now as e post,the company has shown they are incapable of change in the face of failure and should be removed.
Eastbourne and Icahn did a good job changing at the top 2 years ago to reign in ridiculous spending but management was not changed in regulatory.This will certainly lead to a proxy fight or take over of the company.Bydureon should have been selling 2 years ago.
No surprise there. The Amylin norm has been to hire young individuals and give them an inordinate amount of responsibility.
A good number of their current employees are second and third-tier -- relatively junior individuals with not much depth of experience. Worse yet, some are the "cast offs" of other failed biotechs who don't know the right way to do things. Give 'em a bump in salary and title and set 'em to work learning it as-they-go. A top-heavy, overconfident and in many cases, INCAPABLE organization. EXECUTION has always been; and will always be their "Achilles Heel".
To work there is a completely UNDERWHELMING experience. Highest proportion of 30-something undistinguished Director-level employees I've ever seen.