v3.22.2
Subsequent Events (Details)
Aug. 01, 2022
Subsequent Event [Member]  
Subsequent Events (Details) [Line Items]  
Subsequent event, description the Center for Medicare & Medicaid Services, or CMS, published in the Federal Register the conditional New Technology Add on Payment, or NTAP, reimbursement for DefenCath of $4,387.50 per average hospital stay, which assumes 3 vials of DefenCath utilized for catheter locks following 3 dialysis sessions. The NTAP is conditioned upon DefenCath obtaining final FDA approval of the NDA prior to July 1, 2023, and would take effect in the first calendar quarter following the FDA approval of the NDA. NTAP reimbursement would be specific to hospital inpatient utilization of DefenCath, and the $1,462.50 per vial reimbursement is derived from an expected wholesale acquisition cost, or WAC, price of $1,950.00 per vial. The WAC price of a pharmaceutical is essentially the gross list price for a drug product, and not necessarily representative of the ultimate net price charged to a hospital, institution or clinic. The Company intends to submit a duplicate NTAP application to CMS this October, in order to preserve its ability to obtain a new NTAP, should final FDA approval not be obtained prior to July 1, 2023.