gathering momentum , page-14

Re "conference call with the FDA before the AGM" - having worked at TGA and having worked with FDA I can say both organisations are conservative. Although there may be discussions and clarifications during the phone call, FDA would never ever give a final position in a conference call, only in writing and only after internal discussions.

At the most it will be FDA voicing concerns and then it will ask VCR to put its response in writing.
IMO
DYOR etc

Re "teething problems" - this has now been over 7 years!