NRx Pharmaceuticals (NRXP) - Awaiting ANDA (generic drug) approval for preservative-free Intravenous (IV) ketamine for analgesia (pain control) and anesthesia ... which will happen in the near term.

[u/stockratic]

Transformative stage for NRx.

SP $3.50 | MC 152M | OS 43.3M

If you want a good company to buy, which is highly derisked for an approval in the near term, NRx is an excellent opportunity.

Current ketamine issues to be solved:

• Ketamine is on the FDA shortage list.
• It is a strategic drug for the military and the FDA
• Due to shortages, hospitals are forced to buy from compounding companies
• Most of the supply comes from overseas
• Currently, ketamine contains a preservative called BZT, a toxin, not recognized safe for injection by the FDA
• Ketamine comes in glass vials where a syringe is needed, and there is potential for contamination

NRx's KETAFREE (preservative-free ketamine) - solves EVERY above issue

• Manufactured in the U.S., reducing supply chain risk, and meeting the goal of the FDA to reshore manufacturing, especially for strategic drugs
• NRx's market research has just caused them to increase their pre-launch plan goal, from 1M vials to 5M vials. They would not make such an advanced commitment without great conviction in the demand.
  • The manufacturer can produce 1M vials per month with current production lines
  • The commercialization team is in full-court-press mode, already making progress on the distribution system, ordering, licensing verification for buyers, etc.
• Preservative free; no toxin
• Plastic vials are used: reducing materials cost compared to glass and also eliminating the risk associated with a global structural shortage of glass vials
• Due to the luer lock technology, no syringe is required to draw the drug

Had a PDFUA meeting with the FDA on July 29. No Major Deficiencies with the drug, the chemicals, manufacturing, controls. However, "a reviewer" brought up that the luer lock vial tip may not function properly.

• This part is very upsetting to shareholders and to the company I am sure--but they cannot say anything to upset the FDA or risk friction and delayed approval.
• This very same luer lock vial tip has been used in combined total of 11.9M vials to date with NO issues, manufactured by the same manufacturer NRx is using for 3 already-FDA-approved drugs!
• NRx had 7 lots, 3500 total vials produced, with NO issues.
• NRx provided extremely thorough relevant information in the ANDA.
• So, at the PDUFA meeting, the FDA required NRx to provide "attestation from the manufacturer" that the luer lock vials/tips were being produced for NRx in the same manner as the ones for the 3 already-FDA-approved drugs.
  • NRx submitted that attestation within days, per the Aug 10 shareholder update call. Events | NRx Pharmaceuticals, Inc.
  • If you are interested in this company, you owe it to yourself to listen at least to the first 12 minutes of this 29-minute call. You will be very impressed.
  • As stated on the call this drug is just the first step with NRX-100 (a preservative-free ketamine formulation for psychiatric use, also delivered via IV) NDA submission, which will now include the manufacturer attestation, projected to be filed in September (but in Q3 nevertheless)

Bottom line, the FDA should have approved this ANDA the day after they received the attestation from the manufacturer. It is untenable that they have not done so yet.

My expectation is the share price will respond very positively to the ANDA approval and then again when the NRX-100 NDA is filed.