The road to FDA approval isn't Gardening artalways an easy one and is often fraught with road blocks like advisory committee meetings. These meetings are held when the FDA has a few questions about a New Drug ApplicationWorld~~~Crime that a company has submitted, giving a panel of experts in the given field a chance to grill the company about the drug candidate. The FDA doesn't have to follow the decision of these committees, but don't be fooled, the agency often doesn't stray from the panel's choice.ModernMusclecars Not only do these meetings have a major effect on whether or not a drug will eventually be approved, but they also have the ability to tank a stock or make it soar in a matter of hours. Keeping tabs on when the advisory committees will be reviewing the stocks in Unbelieveble Muslims your portfolio is key to knowing when to up your ante or when to cut your losses.QuestCor is now seeking the approval of the drug for infantile spasms, a seizure House building disorder seen in children. The drug is already widely prescribed for the off-label use in the treatment of infantile spasms, but QuestCor currently doesn't have the right to promote the drug for that indication. The FDA already denied approval of Acthar for the treatment of IS in May 2007. Expect a more positive outcome this time around, but don't expect the company to make that much more money off of this indication. Final word on approval of the drug will likely be given by the FDA by June 11.
May 12: The joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Committee will meet at 8 a.m. EST on this date to access the viability of NicOx's (COX) osteoarthritis drug naproxcinod. The company expects to hear a final decision from the FDA by July 24.A few short weeks after the company announced that the FDA required an advisory committee meeting, NicOx released the results of a phase III study showing that naproxcinod performed better than a placebo. The study also showed that naproxcinod didn't adversely affect the blood pressure of patients like naproxen has been known to do. Naproxen is a widely prescribed nonsteroidal anti-inflammatory.
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