Will Parsabiv be turned down again in a week on Feb 9th?

[anonymous]

Parsabiv, which gained EU approval in Nov 2016, got a complete response letter from the FDA in Aug 2016 for the treatment of secondary hyperparathyroidism (sHPT) in adults with chronic kidney disease (CKD) on hemodialysis. Amgen's resubmitted regulatory application is under review with a decision from the FDA expected on Feb 9. According to information provided by Amgen, sHPT, a chronic and serious condition, affects many of the approximately 2 million people across the world who are receiving dialysis, including 468,000 people in the U.S.

It's funny how Amgen didn't mention this as a catalyst at last weeks analyst meeting. They seemed to forget about this product....hmmmm seems like they aren't expecting much. If there were they would have the sales force trained and ready to go on Feb 9th.

 

[anonymous]

get off the thread you tool. Sales force can be trained all they want and it won't matter....see there is a little thing called a billing code and CMS most likely will not assign one until later this summer per their normal policy. No code no sales. Better get back to your sample dropping...this buy and bill is blowing your mind.