Looks like Goldman Sacs Representative was spot on with his question about line extension strategy. I went back and checked and the FDA in their 74-day notice to Amylin did ask for safey data across the entire Exenatide program including Byetta and EQW. I think Amylin put on blinders and relied too heavily on line extension strategy. They should have been more direct with the agency after all the controversy started with Avandia and asked the question if the line extension strategy they were rely on was still the right one.
Here is Goldman Sachs questiona and Dan's answer:
Davis Bu - Goldman Sachs
First question, I was wondering if you could help me understand the implications of the line extension strategy that you're pursuing because I guess on the one hand I hear that you've submitted an integrated safety database for instance and that you have this long safety history with BYETTA but on the other hand I hear you saying that the REMS that was required for the monotherapy label was strictly for BYETTA and has no implications on EQW. So can you help me understand like, how the FDA views BYETTA versus EQW in the context of a line extension strategy?
A couple of things, I guess. First and foremost, I would never be presumptive enough to speak on behalf of the FDA. So let me be really clear here. However, with regards to the line extension strategy, the molecule that is in exenatide once weekly is the same molecule that is in BYETTA. So by definition from a regulatory standpoint, any application of any form of that molecule is considered to be a line extension. As a result, it is important for us to ensure that the agency has full knowledge of all aspects of the study of exenatide in the review. Indeed as part of the 74 day letter that the agency sent us, it was clear that the NDA was accepted as a line extension and important that they also asked us for integrated analysis across the entire exenatide database with regards to safety. So with regards to the REMS, the REMS were specific to the approval associated with the use of BYETTA as first line therapy for the treatment of Type II Diabetes.
And so as a result, it's not actually considered to be part of the review. It's not data that was asked for as part of the submission for exenatide once weekly in our pre-NDA meeting. It's not part of the data that was requested as part of the 74 day letter that we received from the agency during the review. So as such, it's a separate submission that the agency knows that it will be receiving going forward, but it is not considered to be part of the application for exenatide once weekly. Just as there are ongoing clinical studies by the way for exenatide once weekly that the agency is fully aware of and knows that those studies will complete in the future, but they are not considered and they are also studies that have completed subsequent to the submission. They are also not considered to be part of the submission.
I agree with the incompetence thread of quite a few long time Amylin shareholders.I have long called for the replacement of Amylins regulatory team- they have been a disaster. btw? When does an opposing slate have to be entered - I thought it was Dec 31st but?? anyone remember when Icahn came along last time? I would find it hard to believe management will be still the same after May.I still expect a sale jmho GLTAL