I am hinting at the fact that a biotech will always want to present their results best possible, which may or may not be they way e.g. CHMP would view analysis and results. This is why to me seeing the EMA clock ticking again is a good indication that Anavex were able to reply to the LoQ. The fact that there is an LoQ to reply to means that the CHMP team have questions - what those questions are and how and to what extend Anavex can answer them is where the rubber meets the road.
Nothing new here - many get though to approval and some don't. Many reviews are more straightforward than others, say a diagnostics and equipment review versus enormous permutations of data analysis on all sorts of aspects of diverse data.
I hope to see clock start ticking soon - that would a good indications that the questions could be answered. Still no full guarantee, but well on the way...
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