You're working overtime to cast every step forward as a failure, but your narrative is starting to crack under its own weight.
1. India Protocol Flexibility = Adaptive Oncology, Not Chaos
MK did say India’s protocol had local adjustments—but that’s not “improvisation.” That’s standard practice in real-world oncology trials, especially in Phase 1. FDA knows international studies often require regional tweaks. What's relevant is data integrity, not procedural micromanagement.
2. Y90 Shelf Life Argument Is a Red Herring
Every Y90-based product has a half-life challenge—RDGL’s gel is designed to solve that with in-clinic preparation and rapid deployment. Using locally sourced Y90 in India doesn’t invalidate the trial—it reflects logistical optimization. If the delivery method and gel behavior match the U.S. product’s key specs, FDA evaluates the data accordingly.
3. The FDA Doesn't “Fall” for Anything—They Judge on Data
Your implication that RDGL is trying to “bait and switch” the FDA is weak. What actually matters to FDA reviewers: safety, targeting accuracy, stability, and reproducibility. If RDGL delivers on those fronts with documented results, that’s what moves the needle—not your cynical hypotheticals.
4. Rabbit Study Myth
You keep bringing up the 2021 rabbit study like it's a smoking gun, but MK never “botched” it. The FDA asked for additional clarity, not a condemnation. It’s likely the results have been reworked and are now part of the updated IDE materials. You want instant transparency, but regulatory pathways don’t operate on Twitter timelines.
5. Ten Indian Patients = More Than Zero
Here’s what you keep dodging: RDGL has actual human data now. And more is coming. That alone puts them ahead of nearly every microcap with a pipe dream and no clinical track record. This isn’t watered down—it’s foundational.
6. FDA’s Job Is to Say No? That’s Just Lazy Cynicism
No, the FDA’s job is to approve safe and effective therapies. If your view is “they just look for reasons to say no,” then you’ve never dealt with clinical submissions. They ask tough questions because they should. RDGL is finally giving them the right answers.
You’ve made a career out of doubting MK. Fine. But the fact is, the IDE is back on track, global trials are underway, and RDGL has momentum. You can either keep mining 2021 for drama—or start watching what’s happening right now
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