Update from the Hubbard Foundation regarding their meeting with the FDA. Onward!

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Hubbard Foundation
David met with the FDA in Silver Spring Maryland at 10 AM Fri April 26th accomanied by the research coordinator, Heidi Sauder PhD. The meeting lasted exactly an hour and was attended by 5 PhD's and MD's plus one on a video link. Overall, they were friendly and supportive. They explained that the reason they requested a "significant risk" investigational device exemption (IDE) was because balloons and stents are,themselves, are significant risk devices and not because of anything to do with CCSVI or MS. Based on the discussion David is submitting an amendment to his proposal and remains optimistic we will get the approval.