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

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Anonymous said:
hey jesus- nice job- Why don't you take all your external hires and exit stage left -
karma is a bitch they say, so open wide and take a big slurp of the shit soup.

So I guess the company's future is now riding on the mighty Derm franchise that has been at NVS a whopping 6 months!! If it looks like shit and smells like shit, guess what? It's shit!
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Hey - don't forget Arcapta, Tyzeka and oh yeah...Pegasys 20 years ago....
 
























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!!!
 








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.
 




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








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