You're ignoring why Radiogel is being held to higher standard than other brachytherapies. Biggest obvious reason is Radiogel is targeting early solid tumors, so the risk/reward equation is much different vs. a late stage cancer treatment where patient has nothing to lose. That's just common sense.
You're also ignoring the migration concerns have arisen with brachytherapy in general, which RDGL has to address for a Radiogel application.
Likewise, you're ignoring the baseless and bogus comparative safety and efficacy claims MK has made repeatedly to FDA and publicly, without a shred of data to substantiate those claims. All that puts everything he says and submits under a higher magnification exam than would otherwise be the case had he just stuck to the facts in hand.
Then there's his repeatedly insulting FDA reviewers.
All the above is why RDGL is now on slow track with FDA.
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