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purplehp

06/15/18 8:45 PM

#84377 RE: Wolfy3 #84376

I understand that. But is it enough or does it require studies in vivo to prove the "improved version" meets the FDA requirements?

Do you have experience with INDs? I can just interpret the FDA requirements and match them to the PRs. I think pmcb has already met all requirements with the info they have included in the PRs, except perhaps the in vivo studies (and ofc the results of the encapsulation+tests). What is your opinion regarding that? Thanks ;)