Yes, Jonjones, I totally agree on your interpretation that the answer related to the FDA. As to the EMA, I am not sure he could get all the OLE data reviewed and packaged for them by the Q3 MAA submission date the company targeted for them (which by logical deduction is no later than 7 months after the Feb. 7th submission date for the rapporteur process [which Missling confirmed they were part of in early March] - in other words, Sept. 7th at the latest). Right now they have a one month window in which to amend that projected submission date for the MAA, and I presume they have already discussed the OLE inclusion (e.g., full or partial) with the rapporteurs.
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