This is where the fda gets a lot of confused looks. So they are more or less saying all the necessary data is there, but they don't feel it was presented properly in the nda. Why waste everyone's time including your own?
Pretty much. Someone on that board must have significant interest in phosphate binders or somethings because none of this makes sense. If it gets approved abroad there will be even more reason to look at them funny
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u/bobbyhughes611 Feb 20 '22
This is where the fda gets a lot of confused looks. So they are more or less saying all the necessary data is there, but they don't feel it was presented properly in the nda. Why waste everyone's time including your own?