AMLN - Amylin Pharmaceuticals - Page 10
"FDA requested a thorough QT (tQT) study with exposures of exenatide higher than typical therapeutic levels of BYDUREON. The tQT protocol will be agreed to by the FDA prior to study initiation. Additionally, the FDA has now requested the results of the DURATION-5 study to evaluate the efficacy, and the labeling of the safety and effectiveness, of the commercial formulation of BYDUREON. This letter did not cite any manufacturing processes referenced in the FDA's March 15 complete response letter."
Based on the requirements for additional data, this will likely be considered a Class 2 resubmission requiring a six-month review.
Could be dead money for quite some time. Maybe play the FDA meeting or holding for resubmission PRs.
"On Wednesday, Amylin and Alkermes said they hope to resubmit Bydureon’s application by the end of 2011. "
funny how this was rejected ( 3 times ?) in the past, and all of a sudden, bingo it's okay now...must have figured out the correct bribery procedures this time around.
Guys this could be huge.
Currently, there are 7 prospective buyers for this company.
Analysts are predicting a potential bidding war concluding in a low-mid $30 range buyout.
Speculation of this news today lead to a 7% increase.
There have already been 2 rejected buyouts in the past month, both leading to big gains in PPS.