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Thats one reason we stayed largely under the radar during a decade of preclinical development, until we had something concrete to show our IND clearance, which itself required a very large, rigorously built regulatory package. If it translates successfully into the clinic, the implications would extend far beyond a new therapy

Epub 2022 Jun 9

The definition was revised in the 2016 Covered Outpatient Drugs final rule (81 FR 5181 through 5183) and the 2020 Establishing Minimum Standards in Medicaid State Drug Utilization Review and Supporting Value-Based Purchasing for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability Requirements final rule (85 FR 87022 through 87024)

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