DMX 200 has Orphan Drug designation and DXB can apply for FDA Accelerated Approval at 35 weeks (provided good results).
https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program
Ph3 Part 1 analysis confirmed the results seen in the small Ph2 trail also clinically and statistically demonstrated in the much larger Ph3 study I see no reason why the Ph3 Part 2 result with 144 participants will be different from the full trial - same drug treating same disease.
Ann: Dimerix presentation at Bioshares Biotech Summit, page-28
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