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Improved Vascularization

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

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In contrast to the Prescriber-Pharmacy Methodology, the Beneficiary-Pharmacy Methodology would identify potentially 340B-eligible units (that would be treated as 340B units for purposes of effectuating the exclusion at 428.203(b)(2)) as units associated with PDE records that are: (1) dispensed by a pharmacy currently under contract with a covered entity, and (2) for beneficiaries who receive care from a covered entity affiliated with that pharmacy

The legal and quality arguments for waiting for the formal reclassification and transitioning to pharmacy-compounded products are strong