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e the stocks of rival developers of obesity drugs that have been rejected by the FDA, Vivus Inc. (VVUS) and Arena Pharmaceuticals Inc. (ARNA). Orexigen, which has no products on the market and loses money, appears to have enough cash and investment securities--roughly $77 million as of March 31--to last through 2012 as it figures out its next steps, said Leerink Swann analyst Joshua Schimmer in a research note. The FDA said Friday it believes a cardiovascular outcomes trial is necessary to ensure that Contrave's benefits outweigh its risks when used in overweight and obese patients. FDA spokeswoman Erica Jefferson noted that Contrave increases blood pressure relative to placebo in studies. A similar blood-pressure risk, together with increased risk of heart attack and stroke, was the basis for the agency's decision last year to ask Abbott Laboratories (ABT) to withdraw the diet drug Meridia from the market. Abbott pulled the drug. The FDA earlier this year rejected Orexigen's application for approval of Contrave, citing the blood-pressure risk and asking Orexigen to run another clinical trial to assess the risk of heart attacks and other cardiovascular outcomes associated with the drug. In response, Orexigen had asked the FDA to consider approving the drug in the near term for a narrowed population consisting of people with lower cardiovascular risk. The approved use could then be expanded after Orexigen completed the cardiovascular outcome trial, if the trial data warranted the expansion, Orexigen proposed. Orexigen said Friday it proposed a trial of 12,000 to 15,000 patients, with a planned interim analysis in early 2013 that could potentially support approval. The full trial would wrap up about three to four years after starting. But the FDA said Orexigen's proposed cardiovascular outcomes trial wouldn't be sufficient to assess cardiovascular risk, and instead laid out requirements that Orexigen said would translate into a trial enrolling 60,000 to 100,000 patients. "We certainly don't believe that this is necessary or feasible," Preston Klassen, Orexigen's head of global development, said on a conference call Friday. FDA spokeswoman Jefferson, however, said the agency doesn't believe it would take a trial of that size, and that FDA didn't come up with those numbers. She declined to say how big the FDA wants such a trial to be. Also, the FDA said it wouldn't consider approving C
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