You are right but let us expand. The FDA doesn't make it difficult to get an ind approved. The agency truly wants to get novel medications and procedures into clinics so they can be truly be tested to see if they work. The fact that this still has not been approved nor denied makes one wonder just how incomplete regen's submission was to have this still pending. It's been since March of 2013 that REGEN gave the FDA the hemaxellerate paperwork. One has to ask how they screwed this up so badly. I know only Koos and a few others know and that we will never know but it truly tells you all you need to know about management.