**Prefacing with prior information from 9 days ago:**
[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](https://www.reddit.com/r/pennystocks/comments/1vwogb4/the_important_rest_of_the_story_you_need_to_know/)
**Catalyst 1: ANDA approval**
* Since all that was needed was an "attestation" from the luer lock vial manufacturer (see above link), I think the maximum time to approval would be akin to a Class 1 CRL, which is 60 days from the GDUFA meeting that took place on July 29.
* Approval can happen any day now. With great likelihood, it will be prior to Sep 30.
* Per the CEO, NRx is ready to ship vials in very large quantities. It will bring in substantial revenue.
* The potential for NRx to take a huge ketamine market share in a relatively short amount of time is REAL, as it's the ONLY preservative-free ketamine that will be available, it has a 100% domestic supply chain, and the ability to currently manufacture 1M vials per month, with room to increase production with a goal of eliminating shortages of this U.S. strategic drug.
**Catalyst 2: NDA submission for NRX-100 (preservative-free IV ketamine formulation for psychiatric use)**
* If they are granted Priority Review, the PDUFA date will be 6 months from the FDA's acceptance of the NDA, which could mean around April/May 2027.
* If they are granted the Commissioners National Priority Voucher (CNPV), which they have applied for, then the PDUFA date would be 60 days or less from the date of the FDA's acceptance of the NDA.
* According to NRx, NRX-100 meets the criteria for the CNPV (which does not mean they will be granted it).
* NRX-100's NDA filing was originally projected for Dec 2025. The good news is the proposed indication was expanded earlier this year after a meeting with the FDA, likely causing much of the delay. The CEO recently alluded to the filing occurring very shortly (I believe it will be in Sep 2026). He confirmed NRx will be including the luer lock vial attestation from the manufacturer to avoid that snag for NRX-100.
* In the above link, there is a link to the Aug 10 NRx shareholder update call, where the CCO states the ketamine/esketamine market is projected to be **$3B in 2027**.
H.C. Wainwright, which tends to be on the high side of the price target range, reiterated their **$45 PT** a week ago. Last year, other analysts' PTs were between **$25** and **$34**.
The share price should act accordingly upon ANDA approval with a **very-near-term share price of $10 to $12 seemingly very reasonable** based upon the facts and conservative projections.