don't think there is a possibility of 2 month review?
there wasn't any mention of their previously discussed intention to plan a meeting regarding hlhs. must be too much on their plate or a lower prioirity indication from a strategic perspective. i guess that can be an add on to other chf discussions.
eap in adults was up to 51 patients but included adolescents. i wonder what percentage of that 51 is between the age of 12 and 18 and if that might have any implications in terms of the adequacy of evidence to extend into adult ages . if that's the case and it poses an issue to the extension strategy, i guess it wont take too long gather more evidence
2024 Here we go again., page-570
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