I do not understand and hope someone can help, why is the trial being called Phase 2/3. I have watched the CEO mention this in presentations but do not understand how a Phase 2 & 3 trial are conducted concurrently, is there FDA approval to do this announced somewhere I have missed?
My second question relates to comments regarding the Phase 2/3 trial taking 24 weeks. I understand that ODD approval can halve the timeframes, but watching other companies for example MSB new phase 3 trial and DXB's interim phase 3 results, these trials go for 3 years? Do we have approval for a 1 year trial for a combined Phase 2/3 trial, which can then also be halved by ODD approval?
Thanks in advance,
Wanderdog
The Final Charge , Phase I/II MND Results & FDA ODD Approval Catalyst, page-875
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