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The FDA has designated BPC-157 as a Category 2 bulk substance, explicitly placing it on the Red Light list due to significant safety concerns and a lack of clinical validation data

19, 126, 152, 154, 190, and 190 10 6 platelets/mL, respectively)

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We note that, in accordance with section 16002 of the 21st Century Cures Act, we apply a budget neutrality factor calculated as if the cancer hospital adjustment target payment-to-cost ratio was 0.88, not the 0.87 target payment-to-cost ratio we discuss in section II.F