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Lykiri

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Lykiri

Re: longfellow95 post# 251966

Sunday, 11/17/2019 5:41:43 AM

Sunday, November 17, 2019 5:41:43 AM

Post# of 709751

I'm sure these are the issues that are preoccupying NWBO to a hugely greater extent than just the drafting of an SAP.

It's a complex area with new regulatory initiatives and guidelines coming along all the time. Along with imperfect harmonisation between the different international regulators.



I agree.

Longfellow95,

thank you for both articles. I read the last article a while ago. I admit, it is a key paper on CMC readiness for advanced therapies, and the regulatory framework.
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