And finally a summary of the Presentation by "Prop Think"
Just Google "prop think InVivo biotech"
and select the link that starts with: Meeting with Management
and scroll down to InVivo,
Here is the summary by "Prop Think"
"InVivo Therapeutics (NVIV) - Meeting with Frank Reynolds (CEO) and Sean Moran (Director of Finance). I always enjoy meeting with the team at InVivo. No one is more passionate about what they do than Frank Reynolds at InVivo, and rightfully so. Frank spent five years of his life in a wheelchair. The key takeaway from my meeting with the team at InVivo is that management is confident human studies will begin in the next few months for their biopolymer scaffolding product. In an October 2012 letter to shareholders, Frank Reynolds noted that the FDA has confirmed the regulation of the scaffold product as a device. In December 2012, InVivo filed a request with the U.S. FDA for a Humanitarian Use Device (HUD) designation for its biopolymer scaffolding product for the treatment of acute spinal cord injury. The request comes after an April 2012 meeting in which InVivo and the FDA discussed the requirements for the HUD designation and the potential for the device to be regulated and distributed under a Humanitarian Device Exemption (HDE). A HUD designation and a subsequent approved HDE would enable InVivo to commercialize the device in the U.S. faster than the Pre-Market (PMA) approval process. InVivo is guiding to start the 5-person human study in the next few months, with data rolling out two months later. If the trial works, I think InVivo will request HDE approval by the end of the year. That could send InVivo shares soaring. This is certainly a stock to watch in 2013."
Humanitarian Use Device (HUD) will pave the way for InVivo's spinal scaffolding device to be regulated and distributed under a Humanitarian Device Exemption (HDE), which would shorten approval time logarithmically.