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Matt Lewis's avatar

Thanks for putting this out into the ecosystem, again.

I’m not sure the community would agree, however, that a digital mental health platform granted marketing clearance by this FDA, is any indication of potential real world effectiveness above and beyond that purported by options available OTC.

And, as you mentioned herein, the commercial success of firms like Click, Pear and Akili have all been lackluster, and I know their C-suites personally, but in digital mental health, unlike in neuropsychiatric drug commercialization, there is no correlation between clinical efficacy in a trial and real-world effectiveness in the actual world.

Perhaps instead of asking what additional evidence is needed, which rarely changes the clinical picture for the person with lived experience, we should ask instead how to tailor existing interventions to those in need and determine what needs those who are suffering continue to have that remain unaddressed.

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