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stock_peeker

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stock_peeker

Re: None

Thursday, 03/29/2012 3:38:28 PM

Thursday, March 29, 2012 3:38:28 PM

Post# of 10807
15:35 VVUS

Vivus: FDA Panel votes 17 for VS 6 against in vote regarding requirement of cardiovascular outcomes trials for drugs without a theoretical risk or signal for cardiovascular harm
The full question read: Do you believe that obesity drugs without a theoretic risk or signal for cardiovascular (CV) harm should be required to rule out a certain degree of excess CV risk with a cardiovascular outcomes trial (CVOT) or an appropriately sized meta-analysis of phase 2 and 3 MACE data?

This strong yes vote could be seen as a negative for weight loss drug companies, who now may have to run additional CVOTs to convince the FDA of a drug's safety. Companies impacted by this vote includes Vivus (VVUS), Orexigen Therapeutics (OREX), and Arena Pharmaceuticals (ARNA).

Kurt Vonnegut wrote some great books and had a great philosophy of life:


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