They were asked.....if multibillion dollars product is months from approval, why are they leaving? Giving up huge bonus, stock options, years of job stability.... Why? (The responses given don't make sense)
Amylin needs a competent, educated, experienced regulatory group for FDA interactions, the group meetsnon of these criteria
everything in the dark eventually come to light......the fu@k ups committed by regulatory will come to light
funny Regulatory YELLS about how important they and how they should be involved in all discussions, however R&D Leads the regulatory strategy Writes regulatory documents Even writes cover letters
R&D should get full credit and be held accountible for 2 CRL and the decision in January then. Why we took the lead when we don't have regulatory experience? Roll them dices.....