- Judgement-call was to go for a grade 3 glioma label and time the approval of DCVax-L to roughly coincide with the approval and validation of the of Flaskworks' Eden automation system.
You guys keep doing this. Month over month, year after year. The constant speculation has to STOP. The MHRA could quite simply have submitted more RFI's than we expected. DCVax-L is innovative and new to the field. It is not outside the realm of common sense that the MHRA is crossing their T's and dotting their I's with something this groundbreaking. My goodness y'all are relentless.
The recent 10-K comments that grade C labs have not yet been constructed for Flaskworks refer to commercialization. It does not preclude a Flaskworks validation has been happening in parallel.
???????
DOES ANYONE READ THE FILINGS AT ALL? Directly from the 10K:
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.
The GMP units won't even be in production until NWBO starts the build out for the Grade C labs. ONLY THEN will qualification and validation occur, AND ONLY THEN will they submit to the regulators.
Again, from the 10K regarding the Grade C Labs:
Simplified Grade C Lab in the Sawston Facility. The Sawston facility current has two Grade B labs. Such labs are required to be used for any manufacturing process that involves any open steps (i.e., open to the air). Grade C labs are much less expensive to operate, and allow multiple patients’ products to be manufactured at the same time in the same lab, but may only be used with closed systems. The Flaskworks system is closed and suitable for Grade C labs. The design and engineering works were previously completed for two Grade C labs, but the buildout will require substantial capital. Since the Company believes it will have adequate capacity for initial possible commercialization with the two Grade B labs, the Company has held off on raising and using the capital required to build the two Grade C labs. Meanwhile, Advent has devised plans for a simplified initial Grade C lab adjacent to one of the Grade B labs, making use of existing shell space and drawing upon some of the infrastructure associated with the Grade B lab. The simplified Grade C lab can be completed for a fraction of the cost and less than half the time for the regular Grade C labs. The Company anticipates potentially proceeding with this in the coming months when appropriate.
Y'all give Fe-Mike so much crap, but after seeing this over and over I don't blame him.
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