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Re: seekinganswers post# 776361

Wednesday, 07/16/2025 8:57:29 PM

Wednesday, July 16, 2025 8:57:29 PM

Post# of 823599
You just answered your own question without realizing it.

DCVax is a customized, patient-specific therapy. That is why it has always required a manual process. Flaskworks does not convert it into mass manufacturing. It automates specific steps of the existing workflow to improve scale, consistency, and cost efficiency. That is literally what the patent covers.

What you are mocking as a “magic machine” is actually a closed, automated system built to reproduce a validated process under GMP conditions. It is not designed for cows and frogs. It is designed to make autologous cell therapy scalable without losing precision.

And no, the MHRA is not waiting on coupons. They validated the MAA. They issued RFIs. They never shut down the file. NICE confirmed on July 15 they cannot proceed with their review until MHRA approval is granted. That means the application is still active.

The only thing that does not exist here is your grasp of the facts.
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