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TOPIC: Expedited Review Process

Expedited Review Process 27 Jan 2017 15:12 #8669

  • b767cpt
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Recent notification from Maxim that an expedited review process has been approved for regenerative therapy under the 21st Centuries Cures Act.
When I spoke with Mr Hedrick at last summers conference in Vegas, he estimated that FDA approval could take around a year after third phase data for Scleroderma comes out. Under this new review process, I'm assuming it could be sooner?

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Expedited Review Process 27 Jan 2017 17:33 #8672

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The answer to that question is really unknown at this point. Learn more here: seekingalpha.com/article/4030399-president-obama-signs-21st-century-cures-act-implications-stem-cell-sector
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