All delays on RDGL. MK took over a year to respond to 1st draft comments. Now, several months later, MK hasn't even started testing omission (that should have been done years ago) FDA flagged on 2nd draft. The clown needs to be fired.
Y90 kills via beta emission. Free y90 particles in gel matrix vs. encapsulation likely makes a big difference on kill zone and impact on health tissue at margins.
dstep, the difference is that radiogel has the best-in-class margins. there is potential to damage healthy tissue with the precision that the gel provides. others use a seed that cannot prcisely treat tumor margins. we are superior and just have to prove it
No you are not the only one. This is complete B.S. Yi-90 is Y-90 independent of the delivery mechanism. They are definitely jerking us around and this extra testing truly sucks. It feels like the same situation we were in last May. This should have been brought up then. They have to hear the protocol, get a month to ponder it, respond with tweaks then Vivos has to spend a couple of months setting up/preparing for tests. Then if test take 6 months (like the last set of tests) we are right back here next summer.
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