The time frame depends on how quickly Amarantus submits the IND paperwork to the FDA. Sometimes the FDA will immediately grant Orphan status along with the ok to start P1 trials and sometimes it takes longer.

I believe the company would like to get at least the first MANF submission by EOY, if I am not mistaken.

And while it's great that it keeps identifying uses for MANF, it won't do much until AMBS actually submits the IND paperwork.