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Re: RockoTaco post# 127657

Sunday, 05/30/2021 8:15:05 PM

Sunday, May 30, 2021 8:15:05 PM

Post# of 140474
More from fda about breakthrough designation:

Participants will benefit from being able to design efficient and flexible clinical trials and, when practical and scientifically appropriate, receive expedited review of manufacturing and quality systems compliance.

Again, Titan is way past this and has clear guidance and in constant communication w fda