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BioMimetic Therapeutics Inc. Message Board

  • sophia.leghorn sophia.leghorn Dec 16, 2011 11:48 AM Flag

    Why FDA will approve

    The FDA will approve because the risk reward is too easy. Look at the risk: Numero uno, ALREADY APPROVED IN THE US (GEMS);;; Approved in Canada/Australia for ankle/fusion indication;;; Single application drug, no long term issues. Now look at the reward: Eliminates need for autologous bone transplant, a source of infection and healing issues and COST. Let me say that again.....REDUCES COST!!! That is one of the current FDA mantras. The FDA presented its worst case before the panel AND LOST!!! My bet is with the panel.

    Now on to address the letter....

    I find it odd that the letter has not been issued. Yet, assuming 1) the FDA is requiring more preclinical trial; 2) the FDA was specific in the July meeting (and in subsequent communications which I suspect there have been a few), I find it equally odd that there is no new augment clinical study.

    The FDA has been blunt. "Preclinical" means before approval. These are quite specific.

    "With regard to Discussion Question 3, the Panel was in general agreement that the statistical analysis was generally insufficient. The Panel has concerns about power, intent to treat analyses, and general design flaws."

    "With regard to Discussion Question 6, the Panel generally believed that there is a need for additional preclinical and clinical testing for this product with regard to toxicology and teratogenic potential. The Panel felt that particular attention should be paid to pharmacokinetic analysis, antibody production, longevity and dose-response curves."

    Yet the panel voted anyway in favor. And there are no new trials.

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