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Re: TheFollower post# 765649

Saturday, 05/03/2025 1:28:14 PM

Saturday, May 03, 2025 1:28:14 PM

Post# of 824190

I believe the testing has been done and validated by the regulators prior to the new Flaskworks patent just issued.


NWBO stated clearly in the 10K that delivery of the EDEN units that will be tested is on hold until the class C cleanroom is operational. Kind of hard to test something before one has it.

During 2024, the Company’s Flaskworks subsidiary and a specialized contractor developed a GMP-compatible prototype of the Flaskworks system for a “closed” manufacturing process for DCVax-L. Another prototype, with smaller dimensions, had been developed in 2023. The Company has determined that the smaller prototype will be preferable, to enable more units to fit in each manufacturing lab. Production of the GMP-grade units will be timed to coincide with the timing for buildout of Grade C labs in the Sawston facility. When the GMP-grade units are delivered, Advent BioServices will undertake qualification and validation of those units, conduct engineering runs and collect data, and apply to regulators for approval to use the system to produce DCVax-L for patients. As previously reported, the Company views the Flaskworks program and system as a centerpiece of efforts toward scale-up for potential commercial operations.



But I see biosec agreed with your BS pump. So I guess the 10-K was wrong.
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