FoB's are not yet ripe in my view - need to wait for the final FDA guidance before embarking on an expensive program.
I disagree with that assessment and strongly so.
Although not fully specified, the approval pathway for FoB’s is sufficiently elucidated to enable such companies as MNTA to proceed with development without incurring undue regulatory risk. Indeed, MNTA has already told investors that it intends to advance its FoB programs with expedition.
Holding off on FoB programs in order to obtain more regulatory “clarity” would be the height of folly, IMHO.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”