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Re: Doc logic post# 236868

Thursday, 07/18/2019 11:12:15 PM

Thursday, July 18, 2019 11:12:15 PM

Post# of 700522
Doc,
You have repeated that phrase “art” so many times that you must believe that it is, or will become fact if you repeat it enough. Whether these process changes are considered an “improvement” or “art” is still open for interpretation by the regulatory authorities, particularly a change that allows the inclusion criteria to include patients with a lower white cell count. The regulatory authorities may still require additional equivalency studies to determine if the products are essentially the same. Do you know if these studies have been completed? Do you know that these changes were in fact pursued by regulators? Or are you just suggesting that?
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