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Re: djpope post# 15945

Tuesday, 09/12/2017 1:44:48 PM

Tuesday, September 12, 2017 1:44:48 PM

Post# of 18421
Read this carefully no big deal here .

On September 8, 2017, we received a letter from the FDA informing us that our combination product and proposed “indication for use” meets the EAP criteria and that our Hemopurifier has been granted EAP designation. Under the EAP program, we will work collaboratively with FDA to design a data development plan and regulatory pathway intended to achieve FDA-approval of the device, and through this process, we believe the regulatory advancement of our device with the FDA will be accelerated
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