Monday, March 4, 2013

FDA Update

Here's a brief summary of where we stand with the FDA to date: 
May10,2012 FDA stops all CCSVI research
May17,2012  Hubbard Foundation requests an exemption from the FDA
Sept 15,2012 FDA responds with a list of recommendations
Jan 7,2013 Hubbard Foundation submits a formal IDE application
Feb 8,2013 FDA responds with additional recommendations.
 It does appear the FDA will approve our Registry to continue studying CCSVI in MS.

For those of you who are interested in having the procedure please see our map of IR sites who are ready to begin once we get FDA approval.

Let's go with the flow!

No comments:

Post a Comment