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Zalicus AŞ Message Board

  • pattonjim95 pattonjim95 May 2, 2013 1:48 PM Flag

    Orpan drug status?

    Do any of you know if there is a specific trial level that must be attained before an application for ODS can submitted?
    Thanks Jim Long and calm

    Sentiment: Strong Buy

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    • Jim, that's a good question. In all that I've read, nothing has been specific as to what trial level a compound or drug has to attain before it reaches submittal qualification. I've only seen other criteria that it needs to satisfy, the life-threatening or debilitating nature of the condition; the medical plausibility of the proposed orphan indication; that the prevalence of the condition in US is less than 200,000; that it is unlikely that marketing the medicinal product in the US, without incentives, would generate sufficient return to justify the necessary investment; that no satisfactory method of diagnosis prevention or treatment exists, or if such a method exists, that the medicinal product will be of significant benefit to those affected by the condition, one would think that certain criteria would have to been met but I can't find anything