27% increase in heart failure with Onglyza

With this information added to package insert, it is over for Onglyza

 

I know this is so bad that our stock is up 3 percent or $2.10 cents for the reps that can't add. The FDA doesn't know what to think. These people had very serious heart related issues already! They voted 13-1 that the cardiovascular side is safe. The FDA wants to put it in the label but if it's in ours chances are it could be add the the other DPP4's. They other companies didn't do a study in this group and trust me they won't.

 

AstraZeneca (NYSE: AZN) is continuing to session highs Tuesday after it was reported that the company's diabetes drug received a positive FDA panel vote.

The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13 - 1 that Onglyza has an acceptable heart failure risk. The panel also said the drug's label should be changed to add information reflecting the risk.

Committee members were only mildly concerned about an increased risk of death from all causes.

Shares of AstraZeneca are up 3.4 percent.

 

Inquiring minds want to know how/why AZ stock was way up even in the pre-market trading? How could that be? Were people on the FDA committee leaking their decision BEFORE the actual meeting?