Thursday, July 13, 2023 1:33:18 PM
I wish I had your optimistic outlook. My feelings are that we are months away from submitting IDE. I guess it is a lack of patience on my part as I want a life changing financial swing sooner, rather than later...not to mention how many human lives will be lost in the years it will take to get FDA approval to use this for human cancers.
I hope the board realizes that I try to be fact based in all of my posts...and based on how long things have taken, I expect a longer timeline for IDE submission and approval than many on this board. Having said all of that, it APPEARS to me that the genotoxicity study might be the last requirement of the FDA and if that is true, my posts will become more positive as I see the light at the end of the tunnel. If the FDA asks for another study after the genotoxicity, I will sour.
This is just how I am. Make no mistake I realize the technology works and with Mayo Clinic on board I am still very hopeful for IDE approval, just want this to happen without the need for another round of share selling to raise cash. Time will tell
I hope the board realizes that I try to be fact based in all of my posts...and based on how long things have taken, I expect a longer timeline for IDE submission and approval than many on this board. Having said all of that, it APPEARS to me that the genotoxicity study might be the last requirement of the FDA and if that is true, my posts will become more positive as I see the light at the end of the tunnel. If the FDA asks for another study after the genotoxicity, I will sour.
This is just how I am. Make no mistake I realize the technology works and with Mayo Clinic on board I am still very hopeful for IDE approval, just want this to happen without the need for another round of share selling to raise cash. Time will tell
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