My professional experience (not biotech) with authority bodies/quasi-govt organisations is that discussions commence long before the formal lodgement of any application, request etc. is made, as typically these groups are mandated with a response period (30 days). The "review process" on their end should be as streamlined as possible to accommodate bureaucracy in all it's glory (i.e. it should have been reviewed with no outstanding queries because even just rubber stamping something in a month seems to be bloody difficult for these people).
At/around the time it is formally lodged, we should receive a barrage of updates relating to trial design/strategy/locations/key personnel/patent submission(s) etc.
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