First mention of other NNZ-2591 indications was made during the webinar in late February, I think. It was also mentioned in the Annual Report in April.
My feeling is that preclinical studies for any new indications are already completed.
However, Jon Pilcher has stated that, for competitive reasons, these new indications won’t be announced until the Company is almost ready to commence Phase 2 trials.
The first step, I think, is getting the outcome of the EOP2 FDA meeting this month, which will hopefully provide some clarity, not only on Phase 3 trial design, but also on trial design requirements for any further Phase 2 trials. There’s a good chance we will find this out in the coming week.
Back in May, the Company said that after the meeting with the FDA, it will consider whether to proceed with an optimised protocol and design for the Prader-Willi syndrome Phase 2 trial and will assess the best candidate(s) to move into Phase 2 development with an optimised protocol.
In the Roadshow Presentation released last month it was indicated that an upcoming milestone for 2024, after the EOP2 meeting with the FDA, is a decision on whether the Company will advance Prader-Willi syndrome and/or with undisclosed indications.
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