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The NIH just dropped a regulatory bombshell: Notice NOT-OD-26-032. Effectively immediately, Basic Experimental Studies in Humans (BESH) are no longer classified as "Clinical Trials" for reporting purposes. Is this a victory for common sense, or an administrative "fudge" to hide years of academic non-compliance? In this episode, Darshan Kulkarni breaks down why this "Great Reset" changes the mathematics of due diligence, tech transfer, and company valuations. If you are licensing university tech, your "human clinical data" might have just been downgraded to "well-funded experiment."
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