The important "rest of the story" you need to know regarding NRx Pharmaceuticals (NRXP) and the anticipated upcoming ANDA approval for no-preservative IV ketamine

"No-preservative" means "preservative-free" (this sub's rules don't allow "free" in the Title)

A glitch within Reddit omitted/deleted an important subsection of a prior post re NRXP's ANDA. Below is an important piece of information as to why the ANDA could be approved any day now.

The one remaining item identified by an FDA reviewer, which prevented an approval at the July 29 GDUFA meeting was the alleged potential for the luer lock vial tip to malfunction.

* NRx's manufacturer of the luer lock vial, has already manufactured **11.9M** vials with no incidents of failure.
* Those vials were produced for 3 already approved FDA drugs.
* NRx had 7 preproduction runs of luer lock vials, for a total of 3500 vials, with no issues.
* NRx already included substantial relevant documentation about this subject in their ANDA.
* The result of the FDA GDUFA meeting was a requirement for NRx to submit an attestation from the manufacturer that the luer lock vials which will be produced for NRx will be made in the same manner (and if I recall correctly, from the same production lines) as the 11.9M vials stated above.
* That attestation was submitted by NRx within days of the GDUFA meeting according to the Aug 10 shareholder update call.
* **If you can make time, listen to at least the first 12 minutes of this call.** You will be highly impressed (CEO and Chief Commercial Officer speak).
* 2nd Event listed on this webpage: [Events | NRx Pharmaceuticals, Inc.](https://ir.nrxpharma.com/events)

The FDA acknowledged that due to not having any other Major Deficiency and the ongoing ketamine shortage, they would address the attestation submission with priority.

**Now that it's been about 3 weeks since the manufacturer attestation was submitted by NRx, I believe it likely that approval is coming "any day now" (time will tell if that will be this coming week or two weeks from now, or longer).**