I’m sharing information that I researched - you guys can review it and make of it whatever you want. No one has perfect information but the more we know, the better for us. Here’s the final piece from my research:
Based on European Medicines Agency (EMA) regulatory procedures, the drug that did not trigger a clock stop 2 but had a list of questions in meeting highlights is Onureg (azacitidine). This happened during its 2020 review for a marketing authorization application (MAA).
Here's a breakdown of the specific scenario:
* Context: The EMA uses clock stops to pause the 210-day review timeline for a drug's MAA.
* Clock Stop 1 (Day 120): At Day 120, the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a List of Questions (LoQ) for Onureg, which triggered the first clock stop.
* No Clock Stop 2 (Day 180): After the company submitted its response, the CHMP issued a List of Outstanding Issues (LoOI) at Day 180. However, this did not trigger a second clock stop because the company's response strategy to the LoOI was discussed during a Clarification Meeting. This approach allowed the review to continue without pausing the clock a second time.
* Meeting Highlights: This specific case was later highlighted by the EMA as an example of how discussions during a Clarification Meeting can address outstanding issues without the need for a second clock stop, thereby potentially shortening the overall review time.
I’m aware this drug is in the minority. The likelihood of this happening with AVXL is small but I bet their lawyers are aware of this case and flagged it. I would have if I were their lawyer.
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