Just a quick comment. There's a lot of good in the FDA as it exists. No Thalidimide babys for 60 years.
But the fact is that NVIV seems ready to hit the ground running, and this extended dialogue to work out minutia is not beneficial to medical progress at all. Think of all the SCI patients at the mercy of this red tape laden bureaucracy. InVivo is working on a hydrogel class of products to treat a host of indications, they are working with rodents for chronic SCI and future renditions of the scaffold, and yet they have to deal with clearance on the initial product which should already be helping the acutes. The FDA needs streamlining or the rest of the world will pass us by with new innovations.
I realize that In Vivo hold the patents for the scaffolds/hydrogel treatment etc---but for how long? what would stop scientists in China/India etc.who probably are not under the same strict guidelines rules to go ahead and use a similar polymer that they have developed and get on with this study/treatment? (not unlike stem cell treatments going on in those countries)