My understanding is there is no process for continual communication between EMA and TIS/BSI. Our responses were submitted and EMA then takes 2 months assessing those responses and deciding whether there are any outstanding issues. If there are then they list the issues and put them before the CHMP meeting for ratification before sending them to TIS/BSI. If there are no issues they give a positive opinion for a CE Mark.
In my opinion the fact that we haven't heard about any communication between TIS/BSI and EMA since responses were submitted to the questions means nothing and I would be very careful about hanging your hat on that fact.
DYOR and good luck to long term holders. If I manage to pick up any news (good or bad) before an announcement to the market I will post it on HC.
Rev
Wednesday 24, page-2
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