RE:RE:RE:RE:RE:Regarding the 2 questions of the FDAQuite an elaborate explanation.
Plain and simple :my understading is that the back and forth ''questions and anwers'' is complete and at on point the FDA has a final delay to state on the product for a ''go-no go'' approval .They have up to 60 days for the decision but when did the ''clock''begun to run ?
Most probably ML has the date of the final submission and it should be interesting to know that date and we could make our own guessing !