Ann: Proposal to Negotiate Non-Binding Letter of Intent - Merger, page-141

Do your own research is one piece of advice. I did mine.
my post is factual, well at least the one that said Thumbs up etc etc.

On a serious note, the fda is stacked with options for getting this device through asap. You mentioned it yourself but still need someone elses facts and research. Must be the kind that asks questions he knows the answehttps://www.fda.gov/medical-devices/investigational-device-exemption-ide/expanded-access-medical-devices

r to. Also known as someone who loves the sound of his own voice.

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/early-feasibility-studies-efs-program

https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program

go do some reading chronic obstructive airways disease, learn something of use and take a chill pill dude. Addio. Sprecco di tempo ( you can learn this one odessy )