FDA meeting timelineThought people might want to get a handle on possible news flow timeline from the FDA meeting. I'll start with what I came up with, it may be wrong, anybody know with more certainty how this works?
This seems to be the relevant FDA guidance document. I think we are a type B meeting.
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf What it suggests is the process should have already started in that IMV have already submitted their package to the FDA (30days prior to meeting - Fred said meeting scheduled for Dec).
Through a dialogue prior to the meeting issues can be essentially resolved if IMV and FDA agree. These preliminary responses seem to not necessarily constitute the final FDA response though.
Once the meeting happens the minutes of the meeting become the official record of the event, these are produced by the FDA within 30 calendar of the meeting.
It seems possible that if there is general agreement between FDA and IMV then we might get an update very soon after the meeting. My expectation is it'll come when IMV receive the minutes as these constitute the official record. So we should get an update before the end of January. Anybody think it might come immediately following the meeting?