Awesome development - I see it as a higher TAM, and a smaller trial to run which will aid FDA conversations (Phase III with 240 patients with primary endpoint of ICP, and a smaller Phase III with 40 patients for primary endpoint of vision/headache)
I do wonder, given that it's an orphan indication, and that each Phase III having US trial centres, where the FDA would possibly accept it for their adult population post those trials occurring.
I'm very happy with this news.
Ann: Invex Receives Approval for Paediatric Plan from the EMA, page-3
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