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Verastem, Inc. (VSTM) Message Board

  • fastmoneypete fastmoneypete Jul 19, 2013 11:39 AM Flag

    11:02: FDA grants VS6063 Orphan Drug Designation status

    Just posted on FDA site
    Go to "Orphan Drug Designation and Approvals" search page
    Copy and paste in the Product Name search box: N-methyl-4-({4-[({3-methyl(methylsulfonyl)amino]pyrazin-2-yl}methyl)amino]-5-(trifluoromethyl)pyrimidin-2-yl}amino)benzamide hydrochloride
    This is great news for VSTM!

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    • Did anyone doubt that mesothelioma would get orphan status???

    • Nice catch, Pete.
      The FDA page shows:
      Date Designated: 07-18-2013
      Orphan Designation: Treatment of mesothelioma
      Orphan Designation Status: Designated
      FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
      Sponsor: Verastem, Inc.

      I did some searching and then left a couple of questions by voice mail for an FDA rep.

      • Does "Designated" status mean that the company will receive incentives (for instance a period of exclusivity, tax breaks, etc.)?
      • Does "Not FDA Approved for Orphan indication" mean the drug that is in clinical trials hasn't been approved for marketing.

      That seems kinda self-evident but I didn't find any source that defined the terms.

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