Circling back to this, it has been clarified that as it will be a hospital treatment it will automatically be covered by Medicare/Medicaid and private health insurance.
Goes without saying that if the product is approved by the FDA next year, penetration into the US market will be achieved much sooner than I initially thought...
Temcell appears to have assumed the mantle of standard of care in Japan, having penetrated approx half of the Japanese market already.
Pretty impresssive considering MSB or MSCs has literally no foot print to start off with in Japan.
Compare that to the US where phase 3 trials have been run and the expanded access program over the past few years... relationships with major paediatric clinics have already been built...
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