Everything you need to know in these FDA Guidelines.
Been following the same issues for some time with Australian company Neuren (ASX NEU) which are conducting trials with an neurotrophic peptide (IGF-1 analogue) for the treatment of Rhett Syndrome and Fragile-X Syndrome which is unequivocally a therapeutic treatment for an unmet need. Also granted Orphan Drug status in USA and Europe as there are clearly no other FDA approved effective treatments for these indications. About to conduct pivotal Phase 3 trial after the end of Phase 2 Trial meeting with FDA to decide on trial design etc.
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