From todays InVivo press release it is now clear that the FDA approval to proceed with trial is expected after turn of year.
From Frank's letter it wasn't clear to me whether he was referring to the approval late this year and then trial start early next year.
"Dr. Alex Aimetti of InVivo Therapeutics to Speak at Working 2 Walk Spinal Cord Injury Symposium
CAMBRIDGE, Mass. (October 31, 2012) - InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today announced the Company’s sponsorship of the 7th annual Working 2 Walk Science & Advocacy Symposium that will take place November 1-3, 2012 in Irvine, CA.
Working 2 Walk is an annual event held by Unite 2 Fight Paralysis to bring together spinal cord injury research scientists, practitioners, investors and consumers for a lively discussion of current research and strategies that will accelerate progress toward cures for paralysis. Unite 2 Fight Paralysis is a not-for-profit organization dedicated to the realization of curative therapies.
Alex Aimetti, PhD, InVivo’s Research & Development Manager, Biomaterials, will speak on behalf of the Company at the symposium. Dr. Aimetti will present on InVivo’s scaffold and hydrogel as well as designing synthetic biomaterials for various drug delivery and tissue engineering applications. InVivo Therapeutics has developed a new treatment that uses a biocompatible polymer-based scaffold to provide structural support to a damaged spinal cord in order to spare tissue from scarring while improving recovery and prognosis after a traumatic spinal cord injury. The Company expects FDA approval in early 2013 to begin a clinical trial for the treatment in acute SCI.""
Hey bob, im thinking we are expecting it anytime between now and first quarter of 2013. I think the holdup has been showing the fda final product design made in new facillity. So however long that takes plus paperwork and things should progress. I can't wait to see how well this works in humans and hopefully all 5 patients get done in a timely manner so they nor we have to wait much longer. I just hope we get far enough to see if it works cause i think Langer wouldn't have gotten it this far if he wasn't sure it would work. Steve
As much as I hope you are right NVIV has usually been overly optimistic on their projected milestone time schedules and the FDA always seems to be more slow moving than can be understood by us investors so I would really be surprised to see a go ahead before February. Lets hope for the best.