No one’s denying that 601 days is a long time. But that’s exactly why we’re here, because the risk–reward is enormous. We’ve seen ample evidence that they’ve been working hard this entire time: building a regulatory framework, collaborating with top academic centers, securing ironclad IP, and establishing a manufacturing process that’s first in class. They already have a GMP-certified facility up and running. They are literally prepared for touchdown.
It’s also important to remember that remaining silent during the MHRA review is standard practice. When you’re in the middle of a first-in-class, process-defined, tissue-agnostic approval, regulators are setting precedent. Any misstep, even an innocently worded update, can cause delays by breaching confidentiality, creating inconsistencies between submissions and public statements, or signaling outcomes prematurely. That’s why companies go quiet until the decision is final.
This wait hasn’t been idle. In the background, they’ve expanded their patent portfolio, scaled manufacturing capacity, validated their method in academic settings, and aligned their operations with frameworks like SI 87 so approvals can cascade internationally. Every one of those steps has been done with the endgame in mind.
The frustration is on our side, not theirs. That’s why I keep posting, to remind people how rare this company is. If we leave the conversation empty, it gets filled by people who want to see the company fail. I understand it’s hard to hold onto that perspective when the stock price keeps sliding, but price right now is about sentiment, not science or readiness. I completely tune out the day-to-day moves. The only number that matters to me is the one after approval. If it drops to 15 cents before then, I’ll just buy more. That’s the truth.
And with my birthday falling exactly on this year’s 10-Q filing deadline, I wouldn’t mind if the next chapter in this story lands as a candle on the cake.
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