Obviously it confirms the FDA's biased against Amylin, but what does it also tell us about Amylin's Managements inability to handle the FDA's regulatory process ?
It just says to me that some companies donate to the DNC, some not so much.
If you read the PR you see not only did the FDA ask for the heart analysis,they also asked for information about labeling, so the labeling part of the CRL was not sufficient for the FDAObesity ! ; - ) Good Luck to all longs
The co has said 20 months and that should be all timeline.If it is longer and IT MAY BE (remember SYMLINS! 2+ yr ! )then you will hope for $23 buyout and AMLN will be history, a story of a great R^D co destroyed by inept management.
I would agree with your conclusion of 'inept management'. But I see that inept management to be in the FDA. Perhaps what is going on is not criminal but it is, at the least, incompentence.