I'm with Birdseye on this. ODS designation and outright FDA approval appear to be two different beasts. Besides, we should all hope it hasn't been approved to such little fanfare as to not even warrant an announcement. The granting of ODS approval, whilst generally considered a given, is a significant milestone for Prima and l doubt very much we'd be reading about it since 9 am this morning without as much as a whimper or a word from Prima.
fda ods approved, page-18
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