JM17

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Why do you think you're right?

More likely that there is no approval by the imminent cutoff date, given the nearly 1 year review timeline for new devices. No concrete evidence that any devices meeting the criteria were submitted by mid-2025.  

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Why might you be wrong?

a Device may have been submitted to the FDA without notifying the public. Most companies in the space are private, so this would not be shocking. FDA held an advisory committee related to Gen AI digigtal mental health devices in November, 2025. signalling that there may currently be such a device under review. given recent layoffs at the FDA, unlikely they would host an AdCom just for fun. 

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1. Historical trends indicate that July Seizures are typically up to ~flat from June seizures. (at face value, 2022 data is contrary, but 2022 seems to be impacted by an outlier year with very high seizure of Khat, which was not repeated in years since. 
2. 2025 YTD had a general positive trend, driven at least partially by Trump's prioritization of this issue. no reason for this to stop.

3. 

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