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05/01/25 1:48 PM

#188119 RE: WALLnut #188052

You're making my point in your confusion. RDGL isn't using locally sourced Y90 (as they should, but MK is an incompetent moron). RDGL is shipping a one pack product from USA to India, which because Y90 has no shelf life, means he's running India trial with a different and weaker product vs. what's he's peddling to FDA. RDGL can't even do a competent phase 1 trial with this aged watered down product. And this is the only additional data he has since his 2024 IDE application abortion.

Because RDGL lacks operations in India, the most expeditious way to properly trial Radiogel would be to go back to the two pack formulation before MK's "improvements" and have the Y90 part toll manufactured in India. But the moron isn't smart enough to do that.

Regarding the rabbit studies, in addition to the flawed 2021 rabbit study (Dr Fisher made bogus containment conclusions, but failed to do any Y90 PET scans during the critical 10 days where Y90 is hot enough to be a concern), all appearances are MK f-ed up the repeated rabbit studies in 2023-24. He first lied the testing was favorably completed when it wasn't. Then he took a year to write-up and submit results to FDA after saying it would take 6 weeks. Was this a fool's attempt to put lipstick on a pig? Then he withdrew the 2024 IDE application to FDA with that data, So to date, FDA has not formally reviewed the repeated rabbit study as they only formally review test results in application submissions, not in pre-sub program. So gotta wonder how badly MK f-ed that up the repeat Rabbit work?

Since then the only addition data he's gathered is for ten phase 1 patients who received a different aged product than he's peddling to FDA. They don't take fools lightly at FDA. Will MK ever stop giving FDA reasons to say no? Is he too incompetent to know these FDA reviewers aren't fools?