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Re: Echo20 post# 64283

Thursday, 12/13/2012 4:57:51 PM

Thursday, December 13, 2012 4:57:51 PM

Post# of 146240
I received the following from Dr. Seymour today.

"I can tell you the following since it's already public information.

For the FDA to accept GMP designation, it's all about the paperwork. Many countries are satisfied with operations under GMP conditions which is what we'll have. We'll finish the paperwork and get the inspection while we're in human trials offshore.

Australia has nothing to do with the USFDA.

Toxicology can be done with research materials, not GMP materials so they can start as soon as the material is ready for testing.

Sincerely, Eugene Seymour, MD, MPH
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