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Re: MissedSTEMI post# 106196

Friday, 08/14/2020 11:06:20 PM

Friday, August 14, 2020 11:06:20 PM

Post# of 232880
Question, MissedSTEMI: If the FDA does not decide in our favor, is there any kind of emergency appeal process? Any other recourse?

For the life of me, I can't see how - compared to other current alternatives - how our safety/efficacy results don't make us a slam dunk for immediate approval.

And if there is no appeal process, there should be. No bureaucracy composed of people who can't be prosecuted or fired should have absolute power in life/death situations. Every system needs positive/negative repercussions or it ceases to be responsible and responsive.

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