We already know per MK the India docs are not following the "exact protocol" but rather are improvising on the fly with the ten phase 1 patients treated so far. Not saying that's bad, but let's not pretend any FDA and/or Mayo input several months back has any relevance now or that the original plan is being still being followed, when we know per MK that is not the case.
Hard to see them getting out of phase 1 without using local Y90, as Y90 products have no shelf life, and even if they do, will FDA accept data for a different aged Y90 product than they intend to market in USA? Seems very unlikely FDA would fall for bait and switch data vs. the product RDGL seeks to market in USA.
FDA's job is to look for reasons to say no. MK needs to stop giving them reasons to say no. For years now, MK has given FDA reasons by the boatload to say no.
Gotta wonder how badly he f-ed up the repeat rabbit studies FDA suggested in 2021, given he still hasn't submitted those results to FDA? Withdrawn IDE applications don't count. And what other data has he gathered since his aborted 2024 IDE application, ten phase 1 patients out of India with an aged, watered down product? Is that gonna make a difference with FDA?
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