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Comment: A commenter who opposed to the proposal stated that they objected to an ACO's termination from the Shared Savings Program for failure to meet quality performance standards in more than one performance year, as described under 425.316(c)(3)(ii), and suggested instead that a termination be decided on a case-by-case basis

For TB-500, the status is similar (Investigational New Drug in the US) with very limited human data

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If it arrives warm after shipping, move it into controlled cold storage promptly and document the arrival condition if the vial is part of a formal research workflow