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  • granicus007 granicus007 Apr 10, 2013 4:35 PM Flag

    Acthar competition-just how hard is it to get alt drugs approved?

    I came across this on S/A by Healthcare Specialist
    An excellent article regarding the FDA Clinical Approval Process can be found here.

    To summarize this process:

    Drug development can generally be divided into phases.

    The first is the preclinical phase, in which the compound is developed towards a purpose, and tested in animals. This usually takes 3 to 4 years to complete.

    If successful, this phase is followed by an application to the FDA as an investigational new drug (IND).

    After an IND is approved, the next steps are clinical phases.

    Phase 1 focus on the safety and pharmacology of a compound

    Phase 2 examine the effectiveness of a compound

    In Phase 3 researchers try to confirm previous findings in a larger population, and these studies are used to demonstrate further safety and effectiveness and to determine the best dosage.

    These phases require approximately 1, 2, and 3 years, respectively, for completion

    The manufacturer then files a new drug application (NDA) with the FDA for approval.

    After receiving an NDA, the FDA completes an independent review and makes its recommendations.

    Once the review is complete This application can either be approved or rejected, or the FDA might request further study before making a decision.

    Following acceptance, the FDA can also request that the manufacturer conduct additional postmarketing studies.

    Overall, this entire process, on average, takes between 8 to 12 years, although it has been somewhat shortened by The Prescription Drug User Fee Act of 1992 (PDUFA) which was designed to help shorten the review time.

    (click to enlarge)


    To reiterate; Investing in biopharmaceuticals is an extremely risky and speculative venture, and nothing demonstrates this risk more than the simple approval statistics. From conception to market, out of every 5,000 to 10,000 compounds that enter preclinical testing, only one is approved for marketing.

    Sentiment: Strong Buy

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