The two clock stops are after the MAA has been filed and validated.
Before filing sponsor can seek advice on the MAA completion and if that delays the intention to file date, then they must skip to a new scheduled filing slot where rapporteurs are available.
Perhaps that is what you meant? I can well imagine that Anavex could find complying with the criteria for a valid MAA filing a challenge.
I have previously looked into this I don't think this is correct. The minimum 7 months thing refers to there must be a minimum of 7 months from letter of intent to submit to submission so that has already passed. In regards to rappateurs the rule is they are only appointed when the applicant is expected to submit the application within 6-7 months. So this is actually a maximum time guideline rather than minimum. Basically they don't want rappateurs appointed and then have delays. This is why Sept was the original guideline based on rappeteurs however it would appear things will slip a couple of months. Therefore in terms of EMA I don't there is any minimum time anymore it's just how quickly they can do it. Also I haven't seen clock stops mentioned in the pre-submission stage, it only seems to happen after submission as part of their main consideration of the application.
Market Data 
Markets 
AI
