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Bostick, Thomas [TBostick@intrexon.com] 8/23/2017 5:57:03 AM Beck, Nancy [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=168ecb5184ac44de95a913297f353745-Beck, Nancy] Bobo, Jack [JBobo@intrexon.com]; Matthews, Keith [KMatthews@wileyrein.com] Section 3
Hi Nancy, we appreciate all that you are doing to support our efforts to gain approval of a Section 3 as Administrator Pruitt and our CEO, RJ Kirk discussed. Keith gave us an update on your meeting yesterday. The Section 3 remains the number one priority for our company, and we're doing all that we can to provide the EPA with the necessary information requirements.
Just wanted to make one point clear regarding the EUP. This is not something we wish to pursue. It really makes no sense to us at this point. The FDA decision on a trial would have allowed us to proceed with work in Florida, but we made the decision not to go down that path, so that we could fully commit to the EPA and Section 3 approval. As we have discussed, we are confident that the existing data support a Section 3 registration. Moreover, we are generating the additional confirmatory data requested by BPPD.
So, we are 100% committed to submission of a Section 3 registration application as soon as reasonably possible after the transfer of jurisdiction. I just did not want to leave any room for doubt on our position regarding our sole focus on the Section 3.
Thank you and the EPA team for all that you are doing to assist us.
Best, Tom
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Sierra Club v. EPA 18cv3472 NDCA
Tier 12
ED 002061 00043018-00001