RE:ProMetic has exactly what the FDA is looking for in an NDAI hope you are right, but as I see it, they are still Eggs, and not Chickens, so don't count them yet.
And even if they do all hatch, they may not grow up the way you envision. ;-)
Good Luck to Us !!
Gone til after the first FDA Decision !!
Biofinder wrote: This is for you, all you FUD posters:
I've read all I can find about ProMetic, and the FDA is pretty transparent about what they are expecting from a NDA:
1) Ryplazim has a 100% patient success rate in an unmet medical indication (i.e. there are no available drug treatments on the market today), exactly what the FDA is looking for,
2) pbi-4050 works well in a fibrosis indication (Alstrom Syndrome) where there is an unmet medical need, exactly what the FDA is looking for.
... again, do your own due diligence, and do what you want, I don't care, I got mine.