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Ligand Pharmaceuticals Incorporated Message Board

tycobb1923 1 post  |  Last Activity: May 25, 2016 2:44 PM Member since: Feb 26, 2013
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    Question on fast track

    by donalddoc77 May 25, 2016 10:39 AM
    tycobb1923 tycobb1923 May 25, 2016 2:44 PM Flag

    I won't rehash points as Lobster is correct. However, I would point out that not every product gains this designation as many "me-too" products miss out. Also, discussion of some outcomes & prevalence/provenance data gets reviewed when making such a decision. In this age of biotechs, we are seeing a number of these designations reach fruition though as the treatments tend to be unique and potentially beneficial. So, imo, the way to look at a Fast-Track status provision is - the FDA considers the treatment potentially rendered by the product as potentially beneficial and unique. I have the exact wording somewhere

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