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King23

08/04/22 10:08 PM

#148823 RE: LonghornSean #148822

Thanks for the update

mc73

08/04/22 10:08 PM

#148824 RE: LonghornSean #148822

Thank you for sharing. Looking forward to our first monthly update....hopefully we get one this month.

Cameron12221

08/04/22 10:09 PM

#148825 RE: LonghornSean #148822

Anything to do with gov is a slow painful process and anyone that has dealt with them before would say this too.

In all fairness to the FDA they also are dealing with a new style of treatment and has to cover their butts on everything. Yes y90 is a common isotope used, but the gel aspect is a fairly new thing so it's not like a metal/glass bead being approved when that's already been approved many times.

I'm sticking to my "this is a long term play" and we just have to learn surf the wave no matter how big or small or how fast or slow it is.

At the end of the day Johns Hopkins and Mayo Clinic as well as many state universities are backing this company up. Now private clinics! We're debt free and have a solid share structure from a horrible past from prior management. The FDA is taking us serious and are working with them to make this work. If the FDA didn't want this they would have said no awhile ago.

Obv the sooner the better, but this could take a few years and I'm fine with it. This has way too much legit potential to look the other way. This isn't a idea or a test on paper, we have a working product with serious people making it happen.

den4

08/05/22 5:47 AM

#148829 RE: LonghornSean #148822

Thx for sharing Sean

anderson800

08/05/22 7:51 AM

#148831 RE: LonghornSean #148822

This goes directly to one of my previous comments that they did not have to schedule a meeting in order to get things reviewed by the FDA. This is the same way many SS&D reviews go without having meetings and reviewing and commenting until all issues are addressed.

konshe

08/05/22 11:03 AM

#148838 RE: LonghornSean #148822

Sean,thank you for your good post, Looks monthly update for July should be out soon. PPS should be move up also.


"Moving forward we've made it a priority that CEO Mike Korenko will be making monthly updates on the IDE process."

dekeferrell

08/05/22 11:18 AM

#148839 RE: LonghornSean #148822

Great post, thank you.