instead of getting ready to celebrate the launch of Bydureon over the next couple of weeks like we should be had the drug been approved on October 22, 2010, Amylin Shareholders are now sitting in the dark waiting to find out how a TQT Study is going to further delay the drugs approval due to corruption or mismanagement.
Unbelievable that Dan Bradbury and/or Orville Kolterman are not being held accountable for the sad position Amylin Shareholder now find themselves in.
What a shame the FDA is an arbitrary, dysfunctional agency that makes incomprehensible (and possibly corrupt) decisions to delay the public access to life saving drugs. What a shame that the EMEA will approve Bydureon long before the FDA despite the regulatory process being initiated there far later. What a shame the FDA is effectively making the diabetes epidemic worse by further delaying the introduction of Bydureon. What a shame!
I agree the FDA may just be the problem, which is why I included corruption as one of the reasons. In fact the FDA's prior actions against Byetta having to do with their bogus claims about pancreatitis points the finger of blame and shame at the FDA. That being said, Amylin's Management has to take blame for a number of development, manufacturing and commercial initiatives which they have mismanaged over the years that continue to surpress shareholder value.