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A., et al
While no clinical trials have firmly established its efficacy or safety in humans, the volume of in-vitro and animal model data provides a compelling rationale for its continued investigation
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Thats why the FDAs own technical staff has recommended against expanded access, and the public health group Partnership for Safe Medicines calls them "popular, unproven, dangerous. As Peter Kolchinsky, managing partner of biotech investor RA Capital Management, puts it: Is the FDA going to stand on science or is it going to permit all kinds of snake oil to be readily available? The FDA meeting will last two days
Long-lasting effects One injection lasts 4-6 weeks, so patients only need injections every month or two for maintenance
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