AI
Thursday, April 22, 2010 2:40:55 AM
POZN ($10.78)…VIMOVO Status Report is key to know for the chances of approval on April 30th.
-Primary endpoint achieved in both pivotal trials
-Superior GI safety profile compared to active NSAID comparator
-Celebrex Comparator trials completed
-SPA approved trial with the FDA
What more does the FDA want. Well we know that if they had questions then they would have notified them as they did regarding the clinical trial endpts in 2009. They did that because of the SPA. Vimovo is on a straight path from here!
-Primary endpoint achieved in both pivotal trials
-Superior GI safety profile compared to active NSAID comparator
-Celebrex Comparator trials completed
-SPA approved trial with the FDA
What more does the FDA want. Well we know that if they had questions then they would have notified them as they did regarding the clinical trial endpts in 2009. They did that because of the SPA. Vimovo is on a straight path from here!
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