| Questcor [NASDAQ:QCOR] gets thumbs up from panel |
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| Biotechnology Companies | |||
| Written by Hugh McManus | |||
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As I expected, the Peripheral and Central Nervous System Drugs Advisory Committee, an FDA advisory committee, recommended approval for Questcor's H. P. Acthar Gel on Thursday. The panel voted 22 - 1 in favor of the efficacy of the drug, a drug which was first approved in 1952. The same panel voted in favor of the safety of the drug by a margin of 20 - 1: there were two abstentions. Trading of Questcor [NASDAQ:QCOR] halted all day on Thursday in anticipation of the news. The drug is already used in an off label application for Infantile Spasms [IS]. Questcor's review and re-examination of available data developed a dosing regimen for the drug for IS. In a release on December 24, 2009, Questcor indicated that the PDUFA date for the drug will be June 11, 2010: there is no chance in this date. Given that there are some adverse events with this drug and that it is already in the market and prescribed for the target indication, the best that Questcor can hope for is marketing approval but with the requirement that more safety studies be carried out. If the drug progresses successful, I would expect the stock for QCOR to run up as high as $12 to $14 prior to the June 11 PDUFA date.
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