Day 74 letter due next week. This would be the first real feed back from the FDA. Could well be were they bring up the very strong MAP data and how those markers could be included in the indication.
In my opinoin the FDA would prefer to use MAP markers instead of age . This would mean that they could give accellerated approval and include both adults and chidren in the indication.
Day 74 letter due next week. This would be the first real feed...
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