- agree no predicates on the market for ASD diagnosis    
    -cognoa: company received breakthru device(2018), expected to be de novo
    - device for ASD
    - if they get cleared, they could be predicate
        - first point is intended use, diagnosis of autism would fit this, second is technological characteristics
            -510(k) can show that there's no danger
    - demonstrate your device is eligible to provide more effective to diagnose
- well done mapping the needs insight
- problem is solving the 6 month delay
    - what's the cause? 
    - how does your solution fit in?
- as an investor, it's not clear about how you can influence the wait time
- you created a clear value proposition, but now you have to show evidence of this
- careful with claims slide, need to be clear what will actually be done