NorthWest Biotherapeutics Inc (NWBO): EUROPEAN COMMISSION Brussels, XXX […](2...

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Lykiri

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Sunday, 08/30/2020 5:58:39 AM

Sunday, August 30, 2020 5:58:39 AM

EUROPEAN COMMISSION
Brussels, XXX […](2019) XXX draft

GUIDELINES
on Good Clinical Practice for Advanced Therapy Medicinal Products

https://ec.europa.eu/health/sites/health/files/files/committee/pharm772_gcp_guidelines_annex_en.pdf

Placebo: The use of placebo should be scientifically and ethically justified. When invasive procedures are required to administer the ATMP or for the collection/extraction of the cells/tissues, control groups receiving placebo only should not be subjected to a procedure if it presents more than minimal risk and minimal burden. The risk posed by the procedure should be duly explained in the Protocol.

Dr. Linda Liau's presentation in October 2015:

“The issue is because we have the vaccine made for everybody and we are kinda doing a somewhat invasive procedure on these patients, the FDA actually required us to have a crossover arm when the patients progress."