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Re: exwannabe post# 362706

Tuesday, 03/16/2021 4:54:44 PM

Tuesday, March 16, 2021 4:54:44 PM

Post# of 730111

The GMP certificate (which still likely a year away) says nothing about the product they are manufacturing.



The manufacturing licence is actually granted by the HTA (Human Tissues Authority), I believe. Then there is a separate 'Specials' licence.

https://www.hta.gov.uk/faqs/licensing

Your estimate of a year is way over the top. My estimate is 3 months from now.
(We can check back later on who was closest..)

But yes, getting a manufacturer's licence is not necessarily any indication of concurrent progress towards a marketing authorisation.
Though it could be.

But you can't have the latter without the former.

When the NICE appraisal goes active again, then that will be a better indicator.
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