Agree, juvenile IMHO should have been passed from the outset, I mean part of the FDA approval came from the fact that the compassionate use results etc were added in and although there were not as many juveniles in the original targeted study/abstract it is safe to say if the government is letting it be used for free, why not be able to sell it?
Politics IMHO came into play there, had too some how some way or just normal government operating procedure, do just the bare minimum and keep something in the sack/pantry so you can eat later.
Government is the root of so much waste.
I too am looking for that japan thing somewhere in between it is extremely hard to search Asian languages on the net to see articles etc with other companies have had a very hard time with Chinese in particular, to be able to search to see what articles/government agencies are saying.
They applied for the speedy approval so it could happen anytime literally at this point and as long as their isn't a no, it is still a go. I cannot see any country turning it down, US has the most stringent approval process in the world so I don't see any hang ups there.
As well I still believe that it will be manufactured in Japan by out partners for Japan and Asia they applied and got for medical manufacturing license a just before submitting for JPMDA, makes total sense no import duties, no time wasted, etc etc.
Peace out
Off Topic:
BTW yeas MNLO thing threw me too, I understand it though in a way, they had $$ and a lot of it, FOMX had the already approved deal and another on the way so the money helped till the $$ from sales would roll in fully? That is all I can come up with at this point. MNLO is a funny one it is one medicine and has passed for some treatments but not for others, so the "endpoint not met" doesn't hurt as much as it is being tested for so many different things some will some won't but a fail isn't a fail in the usual sense.
