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Because TB-500 is often overexpressed in malignant cells and facilitates angiogenesis, there is a theoretical risk that it could accelerate the growth of dormant tumors or increase metastatic capacity in certain cancer phenotypes

Any payment between parties set forth in a CCA must not exceed fair market value and must be determined in accordance with a methodology that is solely based on the purposes identified at paragraphs (b)(2)(i) and (b)(2)(ii) of this section

Always add shipping and weigh the price against the lab data, because the FDA notes that suspiciously cheap drugs are often counterfeit

We refer readers to Table C-I3 for an example of how the cost scoring methodology could be implemented for a specific cost measure when the performance threshold is set to 75 points, which is the same example we provided in the CY 2025 PFS final rule (89 FR 98441 and 98442)