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Treatment not a drug.
Paradigm shift toward cultural change within FDA that indicates recognition of the science supporting an entire new constellation of treatment products and revolutions in SOCs for multiple indications.
Recent announcement confirms direction and momentum of that cultural change in medical science posture of FDA.
It's the signal LTSHs understand.
The immunomodulatory/inflammatory mechanisms have been traditionally centre stage but the blockbuster sleeper over next 15 years is the regenerative actions in evidence with the RPD designation for HLHS and the potential treatments that will come, and even moreso the RPD designation opening up the FDA recognition of such life saving MOAs.