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Moderna's vaccine has shown encouraging early results in younger adults, but over-55s and over-70s cohorts represent a bigger safety and efficacy hurdle.
Will FDA-cleared prescription digital therapeutics be able to follow wellness, chronic disease and sleep disorder apps onto the formularies of major payers? For digital therapeutics companies investing in randomized controlled clinical trials, GMP manufacturing and FDA submissions for products, the current absence of public health insurance coverage is frustrating.
A complete response letter from the FDA in June knocked Intercept’s stock price down to 2014 levels, but perhaps the regulator is sending wider messages about NASH.