Morning For clarity:Under the breakthrough device designation,...

Morning For clarity:

Under the breakthrough device designation, they receive a prioritised review and interactive communication with the FDA throughout the premarket review phase so I think you're right that they don't intend to "stop the clock". However, JC also mentions (around the 5-7min mark of the investor briefing) that they have 1-3 days to answer any FDA questions and "they only come off the real-time review if there's a material deficiency, and in both of these cases (soft tissue and vitiligo), we have had no such material deficiencies".

This is what I was referencing when I wrote "No material deficiency notices (FDA's clock hasn't stopped for soft tissue or vitiligo)"