Patrick Tuccio

Patrick Tuccio asked about the FDA's feedback on the accelerated approval strategy for NRx 100, the anticipated PDUFA decision timeline, and the impact of the Commissioner's National Priority Voucher (CNPV) on the PDUFA. He also questioned how the citizen petition to remove benzethonium chloride would reshape the IV ketamine market and ensure domestic supply, and how Hope Therapeutics plans to adopt and generate data for the 1D protocol, as well as integrate NRx 100 and NRx 101 post-approval.

Answer

Matthew Duffy, Chief Business Officer, stated that the NRx 100 NDA, under Fast-Track designation, has not been fully filed yet, pending CNPV decision expected this year, and will include over 60,000 patient real-world data points. He explained that preservative-free ketamine is packaged using blow-fill seal technology, enabling high-volume domestic supply. For Hope Therapeutics, he noted their partnership with AMPA Health makes them the first in Florida to deploy the 1D protocol, which is legal under medical device laws and uses AMPA's portable TMS device.

Patrick Tuccio asked for an update on the accelerated approval strategy for NRx 100, the anticipated PDUFA decision timeline, and the status of the Commissioner's National Priority Voucher (CNPV) grant. He also questioned the impact of the citizen petition to remove benzethonium chloride on the IV ketamine market and NRx's supply capabilities, and how Hope Therapeutics plans to integrate the 1D protocol and future NRx 100/101 approvals.

Answer

Matthew Duffy, Chief Business Officer, stated that the CNPV process is ongoing, with a decision expected this year, and the NRx 101 NDA is not yet fully filed but will be augmented by over 60,000 patients of real-world data. He confirmed NRx's ability to supply all required ketamine in the U.S. using blow-fill seal packaging. For Hope Therapeutics, he noted their partnership with AMPA as the first Florida site for the 1D protocol, highlighting its deployability and legal status under medical device laws.