NRX Pharmaceuticals Inc (NRXP)

[redwolf94]

NRx Announces Recommendation to Continue Enrollment NRX-101

https://ir.nrxpharma.com/2023-03-27-NRx-Pharmaceuticals-Announces-Positive-Recommendation-to-Continue-Enrollment-in-the-Ongoing-Trial-of-NRX-101-in-Patients-with-Suicidal-Treatment-Resistant-Bipolar-Depression

· No safety or futility signals were reported in the first 50 patients

· This patient population could represent up to 1 million bipolar depression patients in the US and represents a portion of the indication expansion recommended in recent correspondence with the FDA

· Trial has been upgraded to a Phase 2b/3 study that may be used for a registrational filing

We expect top-line data from this trial in the fourth quarter of 2023. The Company plans to discuss the path to approval in this population of people with Suicidal Treatment Resistant Bipolar Depression in the planned Comprehensive Breakthrough Therapy Meeting with FDA that is planned for the second quarter of 2023. Additionally, we are opening an Expanded Access Program as required for all Breakthrough Therapy Medicines to make this investigational medicine more broadly available and to accrue the safety database previously requested by the FDA.

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I'm still in this one because I've got a bunch of options expiring in January 2024 lol. Not sure on that $25, oof.
But no matter what, best wishes on the drug helping people in the end.