@madamswer
The announcement advised that there are approx. 30,000 bone marrow transplants globally per year with approx 20% (6,000) pediatric.
Approx. 50% of bone marrow transplant patients develop aGVHD, which means globally 3,000 cases of pediatric aGVHD.
At US$200k per patient (what MSB is being reimbursed in Japan), that is a global market of US$600m.
US/EU market is approx 65% of the global market (from recent AGM), so the US/EU market would equate to approx US$360m annual revenue to MSB (assuming it is used in all cases as front line treatment).
After FDA approval, EU approval would logically follow.
In terms of timing, BLA should be filed later part of 2018 and approval mid 2019 (assuming 6 months to approve under fast-track).
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- Ann: GVHD Day 28 Results Presentation
Ann: GVHD Day 28 Results Presentation, page-46
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