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PG

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Alias Born 03/27/2013

PG

Re: bme post# 92321

Wednesday, 08/21/2013 2:10:12 PM

Wednesday, August 21, 2013 2:10:12 PM

Post# of 158400
Thank you. No, not at all. Given that up to that point of the process, the FDA had not been exactly expediting their responses to the company, the company understands that IF there is further information required by the FDA (although, based on what they had been advised up to that point no further information should be required) that it could very well take several months to obtain the FDA's final decision. You must remember that because this science is relatively new, the regulations and requirements are still evolving.

Again, to the best of my knowledge based on my conversation with Dr. Ichim on 17 July as well as the follow-up PR released by the company, they have satisfied the FDA and a final determination should be forthcoming anytime.

BMSN

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