He's not wrong. You don't know how long this will take. As I understand it the sponsor requests a Type C meeting, and the turnaround is less than 75 days. So possibly Neuren requested this in the last couple of weeks or so.
Remembering Neuren said the additional information would be conveyed to the FDA by email, surely that would've gone through already but there's still an issue hence the Type C meeting request.
If there's still a disagreement, it could start later. But I think Neuren will bite the bullet because they can't afford to wait any longer, time is pressing on and the risk to Neuren in terms of low ball takeover offers etc increases. So they may settle for a less than optimal trial design, which may not translate well to the other trials. Still, regardless of the design I'm confident 2591 will prevail. Here's hoping for mid year start at the latest anyway...
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- Ann: Type C Meeting granted by FDA for Phelan-McDermid syndrome
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Ann: Type C Meeting granted by FDA for Phelan-McDermid syndrome, page-13
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