NEU neuren pharmaceuticals limited

Ann: Type C Meeting granted by FDA for Phelan-McDermid syndrome, page-37

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    JP alluded to the need for another meeting in his presentation at the JP Morgan conference last month. It was clear from what he said then that there was still no agreement on a primary efficacy endpoint.

    "they they didn't um agree with what we proposed at the end of phase 2 meeting but we had a lot of discussion about um options and we have to go back to another loop to go back to them and um propose what we think is is an outcome that will be give them what they need but give us what we need as well so we're right in the middle of that process at the moment um and uh hoping that we're going to get alignment with this with this iteration uh and in the meantime we're making sure that the uh everything moves on in parallel so we're preparing for the pH three trial there's many preparations you have to do uh service providers sites drug you know manufacturing all of that's proceeding to be able to start mid year uh subject to getting that FDA."
 
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