Unless im mistaken it was the FDA that threw the dosing spanner in the works, asking if we could prove 1.5mg was as efficacious as 2mg or not. All PK safety and phase 1/2 trials all used 2mg/kg as far as i know. Biotechs take many twists and turns and the FDA can definately push out timelines.
As a recent example Botanix was set back 6 months and issued a complete response letter because of instructions for packaging ( even though all these items were discussed with FDA prior in their lead up meeting)
research reports and media, page-4273
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