If the upcoming human scaffold studies are successful (as I strongly suspect they will be)-will this be "fast tracked" by the FDA? At In Vivo's shareholders meeting in May Mr. Reynolds seemed to plan for FDA approval/start of marketing near the end of Q4 2014--however I can't imagine an acute SCI patient not "demanding" this technology be made available at least on a "compassionate" basis long before then
Never under estimate the FDA's willingness to slow walk even the most obviously beneficial and needed therapy.
Their first priority is not making even a well justified decision to speed up getting it to the public that later results in a negative reaction that affects their career.
However in this case if the results are unequivical and excellent there will be an explosion of publicity that will make a slow walk politically hard to do. The family of any SCI patient will immediately contact their congressman and beg and threaten them to pull the political levers to get access. Especially effective if a large political campaign donor.
"Never under estimate the FDA's willingness to slow walk even the most obviously beneficial and needed therapy."
Could not agree more, rx7171. Even what appear to be no brainers from the outside, the FDA can find reasons to delay or not approve. Nothing that agency does or doesn't do should come as a surprise to anyone. Nevertheless, let's hope for the best here.