I was hoping to get an announcement stating that the endpoints had been agreed to. I am however happy that there is a clear timeframe and they are still expecting to start the trial in the middle of the year. Overall, there may be a few months delay but I suspect much of this out of completely outside of the company's control. The FDA moves slowly when things are "business as usual" and we certainly know that isn't the case for things in the US at the moment. Things are far from that.
Ann: Type C Meeting granted by FDA for Phelan-McDermid syndrome, page-19
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