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<p>[QUOTE="Anonymous, post: 5246255"]If you view the FDA briefing documents or read the NEJM manuscript the facts are that the incidence of adverse events are similar to etanercept. Both have a higher incidence of AEs than placebo. But the numbers you are quoting are absolute values and you need to consider that even placebo treatment (standard of care) results in AEs. </p><p><br /></p><p>The advisory committee today voted unanimously that the efficacy benefits outweighed the safety risk. </p><p><br /></p><p>I am not a Novartis homer defending the company but you should be familiar with facts and have dome perspective before you try to discredit what is clearly a very impressive outcome from an FDA advisory meeting. While the serelaxin FDA meeting was clearly an epic failure, today's result is a resounding victory.[/QUOTE]</p><p><br /></p>
[QUOTE="Anonymous, post: 5246255"]If you view the FDA briefing documents or read the NEJM manuscript the facts are that the incidence of adverse events are similar to etanercept. Both have a higher incidence of AEs than placebo. But the numbers you are quoting are absolute values and you need to consider that even placebo treatment (standard of care) results in AEs. The advisory committee today voted unanimously that the efficacy benefits outweighed the safety risk. I am not a Novartis homer defending the company but you should be familiar with facts and have dome perspective before you try to discredit what is clearly a very impressive outcome from an FDA advisory meeting. While the serelaxin FDA meeting was clearly an epic failure, today's result is a resounding victory.[/QUOTE]
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Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Pharma/Biotech Companies
>
Novartis
>
Cosentyx
>
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Pharma/Biotech Companies
>
Novartis
>
Cosentyx
>