GIven the 'clear & constructive guidance' from the FDA in June 2021 (see below), I wonder what could have gone wrong with the IND applications ?
"NEWS PROVIDED BY Neuren Pharmaceuticals Ltd Jun 01, 2021, 06:00 SHARE THIS ARTICLE : Highlights:
*Clear and constructive guidance received from pre-IND meetings with the FDA Office of Neuroscience for Phase 2 clinical trials of NNZ-2591 in Phelan-McDermid, Angelman and Pitt Hopkins syndromes
*Positive outcome is an important milestone that enables Neuren to proceed with IND applications for FDA clearance to start the trials"
Not professional advice : please do your own DD
What went wrong ?
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