Subsequent Events	6 Months Ended
Jun. 30, 2022
Subsequent Events [Abstract]
Subsequent Events	Note 7 — Subsequent Events: On August 8, 2022, the Company announced receipt of a second CRL from the FDA regarding its DefenCath NDA. The FDA stated that the DefenCath NDA cannot be approved until deficiencies conveyed to the CMO and the heparin API supplier are resolved to the satisfaction of the FDA. There were no other requirements identified by the FDA for the Company prior to resubmission of the NDA. As part of the NDA review process, the FDA has also notified the Company that although the tradename DefenCath was conditionally approved, the FDA now has identified potential confusion with another pending product name that is also under review. The ultimate acceptability of the Company’s proposed tradename is dependent upon which application is approved first. As a precaution, the Company has already submitted an alternative proprietary name to the FDA which will undergo review. The Company also announced that it has finalized an agreement with Alcami Corporation, or Alcami, a U.S. based contract manufacturer with proven capabilities for manufacturing commercial sterile parenteral drug products. Alcami will function as a manufacturing site for DefenCath for the U.S. market, and the Company expects to be able to submit a supplement to its NDA application around the end of the first quarter of 2023 to request approval from FDA for DefenCath manufacturing. As part of the technology transfer and validation of the manufacturing process at Alcami, the Company also expects to qualify an alternate source of heparin API sourced from a major U.S. supplier. Alcami, as well as the alternate supplier of heparin, have a robust history of U.S. FDA GMP inspections and approvals. On August 1, 2022, 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.

Subsequent Events

6 Months Ended

Jun. 30, 2022

Note 7 — Subsequent Events:

On August 8, 2022, the Company announced receipt of a second CRL from the FDA regarding its DefenCath NDA. The FDA stated that the DefenCath NDA cannot be approved until deficiencies conveyed to the CMO and the heparin API supplier are resolved to the satisfaction of the FDA. There were no other requirements identified by the FDA for the Company prior to resubmission of the NDA. As part of the NDA review process, the FDA has also notified the Company that although the tradename DefenCath was conditionally approved, the FDA now has identified potential confusion with another pending product name that is also under review. The ultimate acceptability of the Company’s proposed tradename is dependent upon which application is approved first. As a precaution, the Company has already submitted an alternative proprietary name to the FDA which will undergo review.

The Company also announced that it has finalized an agreement with Alcami Corporation, or Alcami, a U.S. based contract manufacturer with proven capabilities for manufacturing commercial sterile parenteral drug products. Alcami will function as a manufacturing site for DefenCath for the U.S. market, and the Company expects to be able to submit a supplement to its NDA application around the end of the first quarter of 2023 to request approval from FDA for DefenCath manufacturing. As part of the technology transfer and validation of the manufacturing process at Alcami, the Company also expects to qualify an alternate source of heparin API sourced from a major U.S. supplier. Alcami, as well as the alternate supplier of heparin, have a robust history of U.S. FDA GMP inspections and approvals.

On August 1, 2022, 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.