The AML indications are key to a fast approval under 505(b)(2) pathway. An approval for use of Bisantrene for AML gives a bridge to use of Bisantrene off-label for Breast Cancer.
EM AML gives them a great chance at FDA fast-track or breakthrough therapy. Importantly they are planning for 50 patients for AML at sites in the US (see case study below). That size of patient population is about the number needed (expected) by the FDA for an approval in the US. The US wants data in US patients. The sites in Australia and Europe will just support a case for approval.
The POC trial for Breast Cancer is being run in 2021 as it gathers modern clinical data for use of Bisantrene in patients. This accelerates use off-label as oncologists will then have modern data to justify use of Bisantrene off label in Breast Cancer. The off-label use is important as it helps achieve doctor awareness of performance of the drug for both recruiting for clinical trials and scaling up a drive for market share.
MST valuation of RAC, page-10
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