Monday, March 20, 2017 5:54:50 PM
I'm not disagreeing with you but any change (which might be happening) will take months upon months just to clear up the manufacturing situation.
Even when that is accomplished that doesn't guarantee will happen right away. I know that manufacturing inspection is normally one of the last items in the approval process but we didn't get stopped by manufacturing inspection, we got stopped on the manufacturing warning letter.
With that said, we don't have a clue of where we are in the approval process. And neither does Momenta.
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