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Saturday, August 10, 2013 2:17 AM | CCSVI in Multiple Sclerosis Volg link
The Hubbard Foundation refuses to quit. They are preparing their FOURTH submission to the FDA for approval of treatment for CCSVI. Thanks to the Hubbards for their commitment to those with MS. This has not been an easy process for their family.
"After our son had venoplasty in San Diego performed by Donald Ponec MD, we obtained IRB approval to collect quality of life and adverse event data on patients receiving this treatment. In 2012 we published in Journal of Vascular and Interventional Radiology the results of our first 200 patients. We had collected data on an additional 405 patients when in May 2012 the FDA issued a prohibition on all CCSVI research without their approval. We submitted our application in Nov 2012 and have responded to multiple requests for revisions.
The FDA has recently responded to our application for an Investigational Device Exemption (IDE) requesting additional revisions to the protocol. It has been over a year since our initial submission. This will be our 4th submission. This time they are wanting the scientific rationale for rescue stenting if balloon venoplasty fails,does not successfully dilate the stenosis and they want records from the patient's neurologist documenting the diagnosis of MS. We will be responding to these requests in the next week or two."


Update on MS: CCSVI and Nutrition
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