RE:RE:RE:RE:New Press Release - Kane Biotech Makes First Commercial Sale of revyve(TM) Antimicrobial Wound Gel to ProgenaCare GlobalThey should change their name from Kane to Pfyzer, maybe that would fool the FDA to go faster ;-)
KevinOleary wrote: The timelines for dispersin trials are determined 100% by the FDA. kne just tried to estimate when the trials would start, but it's a mug's game. The FDA is a massive bureaucracy, and doesn't know much about biofilms. The pre-application meetings are widely spaced apart and you don't get to talk to people who will give you a nice blueprint of how to submit an application for something this complex. Instead, you are stuck dealing with people who try to help but have limited data and understanding.
When you say the company doesn't meet timelines, you mean dealing with the FDA is vague and time consuming. All a company can do is guess how much fiddling the FDA will do. Look at the Revyve approval that took so long. There isn't even a labelling claim for Revyve, yet it took 6 months after applying to get approved for a "hydrogel." That's all the claim is on the tube, "hydrogel." That doesn't include the many months of pre-application meetings.