Re: Investor082 — Did the Matrix reload
Genuinely curious. Did you read my post, or did your script just glitch and reboot back to default?
You are repeating the same Kite reference word for word, even though I already broke down exactly why Yescarta’s limited early volume didn’t prevent approval. It proved the point. The FDA approved it because the process was validated, not because the shelves were full. You keep saying volume doesn’t matter as if you are revealing something. No one said volume was the issue. We said process validation is the issue, and in autologous therapy, the process is the product
That’s not a slogan. That’s regulatory science. Backed by FDA guidance, MHRA precedent, and real world examples you keep citing without reading
Flaskworks doesn’t delay approval. It enables scale out after approval. The MAA is built on Advent’s already licensed GMP production, which you acknowledged. So what are you arguing now. That something not required for approval is somehow blocking approval
This isn’t a disagreement. It’s a recursion loop
You are not debating. You are rebooting
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