NRx Pharmaceuticals (NRXP) - Awaiting ANDA (generic drug) approval for no-preservative Intravenous (IV) ketamine for analgesia (pain control) and anesthesia ... which will happen in the near term.
**Transformative stage for NRx.**
**Note:** In creating this post a msg appeared saying "you may not have 'free' cannot be in the title," so I used "no-preservative," when the common terminology is "preservative-free."
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
* **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 **GDFUA 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.
* NRx provided extremely thorough relevant information in the ANDA.
**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.**