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Companies -
Biotechnology Companies
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Written by Hugh McManus
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Tuesday, 04 May 2010 23:40 |
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I reviewed the advisory committee briefing document on H.P Acthar Gel(R) from the FDA and I think that there's good news in the near future for Questcor Pharmaceuticals. Questcor is an emerging pharmaceutical company located in Union City, CA—the Bay Area. The company submitted an NDA for an already prescribed medicine: the medication was used for an off-label application of a childhood ailment of Infantile Spasms. The API is already used for the treatment of indications associated with multiple sclerosis.
The FDA has prepared a briefing document for the advisory committee. An advisory committee is a group of experts in a particular field that is charged with providing the FDA with an objective opinion about a matter from a safety, efficacy, scientific or other technical perspective. Those called to such a committee are experts in a given ailment or have other qualifications of use to the agency in reaching a decision.
A committee has been assembled by the FDA to review the application for H. P. Acthar Gel. The FDA prepares a briefing document and makes a full, non-redacted version available to all interested parties on its website. The document supporting the submission received from Questcor was published today. It's thorough, detailed and well over a hundred pages long, but if you're a shareholder in Questcor, you should give it some attention. It should be noted that this product is already approved in different ways for over half a dozen other indications; already published results have been reanalyze for this most recent submission. Questcor is looking for specific approval or an extension to include Infantile Spasms.
The bottom line is that the FDA has stated that the advisory committee should look favorably on this drug. Given that the drug is already used, unregulated for the condition without major side effects, there aren't concerns about safety and efficacy. There are concerns about current dosage regimes: if Questcor sells the product, it will have a defined dose and can give guidance to physicians about usage of the drug.
The advisory committee meets tomorrow. If you're so inclined, you can purchase an audio webcast here:
secure.iian.ibeam.com/events/fdcr003/20100/index.jsp?autoLogin=
All in all things seem to be shaping up nicely for Questcor. The company issued a release on Monday indicating that it will hold a webcast on May 10 to discuss the results of the FDA meeting. Here's that link.
ir.questcor.com/releasedetail.cfm?ReleaseID=466002
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