On the surface, the ODD for MANF seems like it will get approved, and then you look around and start to wonder.
Net, I do think it will get approved and get studied, somehow, but there are MANY compounds ahead of MANF. Following the links on that link will show you that is the case.
Again, this submission is good for a trade, after which the pps will go back to a baseline, albeit probably a higher baseline. ( keeping in mind the baseline at the moment is .067.