RE:RE:RE:RE:RE:Technical analysisThere is no way to be conservative and somewhat accurate when you're dealing with the FDA because you have zero idea how long they will dither. For example, the Revyve product approval has no labelling claims other than it is a hydrogel. They didn't claim it works well, or even that the hydrogel deals with biofilms etc. It is my understanding that there is nothing on the label except this is a hydrogel. How long did that take to get approval, 6 months? It should have been approved in a week.
The dispersin trials will be much more complicated because kne will put the label claims that they are trying to prove in the application, and they need guidance from the FDA about what has to be proven to the FDA, in order to get the FDA to allow those claims. If you wanted a conservative estimate of when the FDA would stop delaying this process of asking questions from hell which any biofilm scientist already knows the answers to, so trial would begin, then KNE would have said "within 10 years."