RE: $5m on grant of IND by the FDA20 Nov 2023 14:42
I suppose my point, which is more of a question is when will Evgen be in a position to apply for an FDA IND ?
Could the 'Final Report from Phase 1b PK/PD study' RNS'd in August have been the catalyst for application ?
Final Clinical Study Report from Phase 1b PK/PD study of new SFX-01 tablet formulation approved
New formulation of SFX-01 performs as designed, delivers meaningful levels of drug and metabolites, is safe and well tolerated
Results to be shared with Evgen Partner, Stalicla in support of regulatory submissions for Phase 2 studies in Autism Spectrum Disorder.