RE:"The Call" canadapiet wrote: "The Call", maybe something for a movie.........:-)
In short:
1) timeframe FDA :
they are awaiting the answer from FDA ( request is allready submitted). So that can be tomorrow, but next month is also a possibility......Normally, the FDA will have some questions and it depends on that how fast it can go. (face-to-face, or via mail or by conf call....) . They are very confident they have a strong credible case, and will/can answer those questions very fast. But then it's again in the hands of the FDA and we all know how things go there (but things happen faster lately, so lets hope (again)).
Did you get an idea of
when it was submitted to the FDA (i.e. when did the clock start)?
-LT