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Thursday, May 17, 2012 9:59 PM | Ken Torbert Volg link

Hello all, the head of our national IRB spoke at our conference and explained the implications of the FDA warning to Dr. Mehta. He has been told he must stop enrolling patients and must seek FDA approval (so called investigative device exemption) (IDE) with no certainty that the FDA will accept his efforts at "corrective action".



So David has been talking with the IRB, Dake, Siskin, Ponec, and others to plan the right thing to do. David will seek an IDE from the FDA so that the multi center Registry can continue and even grow but needs to work out the details.



With regard to our testing facility, AFI, we planned on shutting it down for a while now. We have completed our fMRI research, our clinical outcomes data has been accepted for publication and our perfusion pilot study is completed, as well....



Although our wonderful patients had to pay way too much personally for the testing and treatment here this did not come close to covering our expenses and the Hubbard family, not the Hubbard Foundation, made up the difference.



The Hubbard Foundation will now focus on education and trying to raise funds to research the vascular aspect of MS and other neurovascular disorders.



Arlene Pellar Hubbard



http://www.HubbardFoundation.org