SERELAXIN DEAD !!!!!!!!!!!!!!!!!!!!!

2 years in this industry iOS an eternity!!! It will never happen. Long delays are never good -just keep stock owners from bailing too quickly. Does anyone remember Galvus? Ilaris? Will the last one out please turn off the lights!!!

 

Spell check and big thumbs turned "is" in to "iOS" somehow .

 

Hey - don't forget Arcapta, Tyzeka and oh yeah...Pegasys 20 years ago....

 

Prexige & meds pulled or black boxed like zelnorm valturna elidil ....ad nauseum

 

I was referring to Jesus' successful 'specialty' launches.... Talk about getting extra mileage out of Pegasys...

 

Novartis is not about healing hearts. Novartis is about breaking hearts.

 

When is the FDA official announcement?

 

FDA voted 11 to 0 to not approve in acute heart failure! Back to the drawing board Novartis.

 

Seralaxin is not dead. They only had one trial and FDA asked for two. And the one trial had two efficacy variables a big no no since they measured the same thing dyspnea and one was positive and the other negative. The real issue is that Tim Wright forced the company to file in US and EU. He should have done two more trials with the correct efficacy variables and then submitted but due to his lack of experience thought he was smarter than everybody else. Bye Bye Tim. Anymore inexperienced clowns from NIBR come want to run global development? Third times a charm!!!

 

The meeting was open to the public. Word on the street is nvs looked bad. Shamed by the docs on the panel.
Nvs took a big hit to its already questionable reputation.

 

BWAHAHAHAHAHAHAHAHAHAHAHA !!!!!!!!!!!!!!!!!!!!!!!

FDA panel throws dirt on Novartis' would-be cardio blockbuster serelaxin
March 27, 2014 | By Damian Garde

After a daylong session heavy on scathing criticism, a panel of FDA advisers voted unanimously against approving Novartis' ($NVS) in-development heart drug serelaxin, casting serious doubts on the treatment's potential.

In an 11-0 vote, the agency's Cardiovascular and Renal Drugs Advisory Committee struck down Novartis' case for the heart failure treatment, taking the drugmaker to task over the design of its 1,161-patient pivotal trial, gaps in the provided data and serious questions over serelaxin's efficacy. Echoing a particularly harsh review from FDA staff, the panel said Novartis failed to confirm the drug's effect on shortness of breath and the rate of heart failure.

 

One trial where the effect of Serelaxin was comparable to placebo!

 

Sweet justice