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Re: meirluc post# 741455

Wednesday, 01/01/2025 11:09:07 PM

Wednesday, January 01, 2025 11:09:07 PM

Post# of 828166
I know some people don't agree, but I don't believe the current manual production facility approve for use in the UK has sufficient capacity for the UK along, if that's true, until they have more capacity filing with other regulators isn't possible. The EDEN is the key unless someone's building lots of tiny cleanrooms somewhere. I don't believe that tiny cleanrooms are being built by anyone, I believe the company, and any contract manufacturers, are waiting for the EDEN.

I believe the company is working on what's needed to file with each of the regulators, but nothing can be done until a commercial production facility can be inspected as part of the process in considering approval. No approval can be granted if no production facility exists.

Gary
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