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Lykiri

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Lykiri

Re: flipper44 post# 220307

Thursday, 03/28/2019 8:38:41 PM

Thursday, March 28, 2019 8:38:41 PM

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Consistency and reliability is what NWBO stated they needed to accomplish to meet the fourth criteria of the second stage in the EAMS process.



http://yahoo.brand.edgar-online.com/displayfilinginfo.aspx?FilingID=10209821-4542-14028&type=sect&TabIndex=2&companyid=89350&ppu=%252fdefault.aspx%253fcompanyid%253d89350

September 16, 2014

The second step under the EAMS is MHRA’s determination of a Scientific Opinion about the product candidate’s benefits and risks, based on available clinical data. A positive or negative Scientific Opinion will be judged by the same three criteria as for the PIM designation, as well as a fourth criterion: the Company’s ability to manufacture the product to rigorous “GMP” (clinical grade) standards.
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