"Plus MK has already stated genotoxicity with radiogel is a non issue."
Gotta keep it real.
MK's opinion here is not only wrong, it's irrelevant. The only opinions that matter here are those of FDA reviewers. Moreover, it's another example of MK spouting off a product attribute without a shred of data to back up his statement. The fact is to kill a solid tumor, some healthy marginal tissue must also be killed. And beyond the kill zone, some surviving cells may be mutated. Those mutations may cause different cancers down road. So given Radiogel is primarily targeting early cancer, genotoxicity to those surviving cells if a very reasonable concern. What's the point of killing an early cancer tumor, just to cause different cancers down the road? Hence why the FDA wants this addressed.
This is same MK that said multiple times he had plenty of cash to get through IDE approval. Yet each time was following by an offering. And cash situation is as uncertain as ever, because until there's a clear path and timetable, nobody, including MK, has a clue as to the cash needed.
This is the same MK that said this would all be wrapped up no later than Sept 21, 2021. Yet here we are two years later still waiting.
Fact is if Sept. 29 meeting isn't cancelled this week, it means there are unresolved issues that have to be discussed. Maybe those issues get resolved at meeting, but that is unlikely. After all, this is the Fifth pre-sub meeting regarding Radiogel.
Again, gotta keep it real.
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