The real mystery is how much the pre-submission process will pre-empt the approval process. Ideally, the FDA reads it through, says "yes this is what we wanted" and rubber stamps it.
You would hope that, having gone through the process already, TLX will be on the front foot with this. On the other hand, this time they're the first to market, so that may increase the degree of difficulty somewhat.
CB is still on record as saying (a) submission this calendar year and (b) at market in 2024. So (b) fits in with a shorter approvals process.
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