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purplehp

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purplehp

Re: hockeypond post# 84340

Friday, 06/15/2018 9:19:04 AM

Friday, June 15, 2018 9:19:04 AM

Post# of 144812
Can you please provide the link? Last ASCO video here http://pharmacyte.com/news/media/ discusses the trial design in detail but I failed to hear out anything about how far they are with the IND.

I did check the FDA info just now, it would indeed seem we are pretty much there (I only scrolled through it, may have omitted something)

https://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM378678.pdf

https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/xenotransplantation/ucm092705.pdf

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312&showFR=1
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