So in sourcing an answer for myself I sent this to Jon, and as is typical of Jon, received an answer very quickly....thanks Jon.
Hi Jon,
I’d like toshare the answer to these questions on Hot Copper so – if that’s a problem –then I understand, and won’t share.
In today’s4C it was noted that:
Neuren hopes to receive clearance from the FDA after 30-day reviews ofeach submission. All three programs are supervised by
the FDAOffice of Neuroscience, with Phelan-McDermid and Pitt Hopkins reviewed by theDivision of Neurology 1 and Angelman reviewed by the Division of Psychiatry.
- How is it determined that Phelan-McDermid and Pitt Hopkins sit with the Division of Neurology 1 and Angleman with the Division of Psychiatry given it is the same drug? (I recall the same happening with NNZ-2566 around Rett’s and Fragile X at Phase 2)
- Are there meaningful differences for Neuren in dealing with each Division around agreeing the protocol for the IND?
Thanks forany thoughts,
Kindregards,
Ann: Q4 2021 quarterly activity and cash flow report, page-17
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