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MI Dendream

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MI Dendream

Re: FeMike post# 428113

Monday, 12/20/2021 5:41:43 PM

Monday, December 20, 2021 5:41:43 PM

Post# of 817836
How certain are you of this statement?

Pump the brakes on this logic. This certification is in no way, shape, or form tied to DCVAX in that way.

They are allowed to produce DCVax under this cert. This is not a certification specifically to produce DCvax.



I will give you that it may not be limited to DCVax-L, but are you sure that it isn’t the process of manufacture that is certified in addition to the facility? That process is unique to DCVax. I would double check some of your logic and/or assumptions.

Seems to me we got Human Tissue Licensing Authority license to handle human tissue, we got Medicine and Healthcare Products Regulatory Authority certification to produce DCVax in Sawston, and we got MHRA certification to monitor, store, and supply chain manage the process for DCVax in the UK.

Any guess at what comes next across the pond?
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