NRx Pharma Updates On Interactions With FDA Regarding Path To NDA Submission For NRX-101

(RTTNews) - NRx Pharmaceuticals Inc. (NRXP), in an update on interactions with the U.S. Food and Drug Administration regarding path to NDA Submission for NRX-101, said that it has reached alignment with the FDA regarding its proposed registration manufacturing plan.

In Thursday pre-market trade, NRXP was trading at $1.37 up $0.12 or 9.60%.

The company noted that it welcomed the FDA's ongoing guidance and support under the Breakthrough Therapy Designation associated with NRX-101 as well the previously issued Special Protocol Agreement for the treatment of Bipolar Depression in Patients with Acute Suicidal Ideation and Behavior.

NRx said it had a meeting and a written response from the FDA last week regarding its lead compound, NRX-101.

In response to a request for Type C guidance on the chemistry, manufacturing and controls (CMC) aspects of the NRX-101 program, FDA provided Written Responses on January 10th.

With FDA's written response, it appears that NRx Pharmaceuticals has reached alignment with the FDA regarding its proposed registration manufacturing plan.

A Type B meeting with the FDA was held on January 11, 2023.

Minutes of the meeting are expected to be available in about 30 days.

For More Such Health News, visit rttnews.com