THIS IS NOT GOOD!!!!!!!!
When NeuroRx entered into the Relief Agreement (as defined below) with Relief Therapeutics, the expectation was that clinical success of aviptadil for treatment of COVID-19 Respiratory Failure could be demonstrated in a clinical trial of 144 patients over 28 days. In fact, the clinical trial required 196 patients and the FDA unexpectedly required a 60-day observation period to demonstrate success. The additional costs of the increased patient trial population and increased time frame from 28 days to 60 days has been borne by NeuroRx as Relief Therapeutics has, to date, not funded these additional costs. In addition, NeuroRx discovered that the formulation and stability data provided by Relief Therapeutics in its Investigational Medicinal Products Dossier (“IMPD”), which Relief Therapeutics submitted to European Regulators was non-reproducible. The IMPD data documented 18 months or longer shelf stability for aviptadil acetate in saline, a product that is designated as RLF-100 in the Relief Agreement. NeuroRx advised Relief Therapeutics in January 2021 that the formulation documented in the IMPD yielded only 60-day stability and began developing a longer stability product, ZYESAMI, aiming for a shelf life of at least one year. As of April 9, 2021, Relief Therapeutics has not funded the costs of re-formulation of aviptadil into a shelf stable product, which has required NeuroRx to deploy capital from alternative investors. These circumstances may lead to a dispute with Relief Therapeutics regarding what share of profits Relief Therapeutics should be entitled to receive based upon its reduced participation in the project.
