The FDA's green light would establish Akili as the leading DTx firm in the youth ADHD space:
The talks have been ongoing since mid-2018, and it's unclear when the agency will make a decision — highlighting the complex path DTx firms must navigate when seeing a new medical treatment through to market.
Should Akili's prescription video game receive the FDA go-ahead, the startup could be looking at an opportunity to transform a massive market. And Akili would be leading the charge as far as digitally delivered therapies for the condition. Akili could benefit from a lack of competitors in the video game treatment space by branching out into other treatment areas — a strategy the DTx firm has already through its work in the AKL-T03 treatment program, which was designed for people living with major depressive disorder.
Despite the fact that it isn't developing medications in the traditional sense, Akili still has to contend with the notoriously process of gaining FDA clearance. Digital therapeutics must be "reviewed and cleared or approved by regulatory bodies ... to support product claims regarding risk, efficacy, and intended use," per the Digital Therapeutics Alliance.
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