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Monday, April 19, 2021 11:58:30 PM
https://www.pharmasalmanac.com/articles/how-an-agile-company-addressed-the-pandemic-moving-from-psychiatric-medicines-to-a-covid-19-therapeutic
Seems Ives Sagot knew what entity was best equipped to move known molecules through the FDA.
https://www.pharmaceutical-technology.com/features/neurorx-covid-19-respiratory-failure/
AGAIN, WHAT ENTITY KNOWS HOW TO MOVE A KNOWN MOLECULE THROUGH THE FDA???
Relief noted in today's press release that it was well aware of the stability issues related to aviptadil when the collaboration agreement was signed and committed to paying the costs of remediating those issues. When the merger agreement was signed with BRPA and the S-4 was filed, NeuroRx noted that the stability data provided by Relief had not yet been validated or replicated and identified this as a potential risk factor for investors. Solving stability challenges is a common feature of late-stage drug development programs, particularly with peptides such as aviptadil. NeuroRx's formulation, manufacturing, and GMP quality team is led by veteran executives who have piloted similar projects at leading pharmaceutical companies. Relief's nonpayment of those remedial formulation and manufacturing costs has not impeded NeuroRx's progress to delivering a lifesaving drug to patients in any way. Indeed, NeuroRx is actively collaborating with NIH to provide remediated formulation and stability data to European and South American Regulatory Authorities so that NIH can extend its recently-announced TESICO trial to Europe.
https://www.prnewswire.com/news-releases/neurorx-responds-to-issues-raised-by-relief-therapeutics-regarding-zyesami-development-301271869.html
AS I3ryant puts it, “Ram (chair of RLFTF), pay the 4 million expense and let’s move on”...let’s move that known molecule through the FDA!!!
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