Tuesday, October 21, 2025 11:48:34 AM
It will be about a year until pricing is agreed upon with the first EU countries, assuming approval comes next month. Revenues in the EU could be (probably will be) very very low in 2026. There probably will be no real revenue until the 2nd half of 2027. IMO, a pop from basically nothing to $8b (or whatever people are positing) over 2 years (getting to the 4 year range in Jesse's numbers) seems extremely unlikely. Maybe could reach $2b annually but even then that seems like a stretch.
If somehow the FDA were to allow a submission with the stipulation that they are comfortable with the lack of confirmatory trial, then that would be a game changer and were it approved in 2027 then 2028 would probably see well over $2b in annual US revenue. That would justify the $30b+ some people think is possible.
If somehow the FDA were to allow a submission with the stipulation that they are comfortable with the lack of confirmatory trial, then that would be a game changer and were it approved in 2027 then 2028 would probably see well over $2b in annual US revenue. That would justify the $30b+ some people think is possible.
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