The genotoxicity testing needs to be done on real humans.. you can’t do this before IDE.. what FDA suggested is that they need to FOCUS on genotoxicity and by doing the scoping studies they are just doing that.. after this is completed together with their comprehensive risk management report, which concludes that RadioGel is intrinsically safe the fda should give the green light for clinical trials imo.
MK has gone dark??? C'mon, man... MK is diligently working on the next installment of the VIVOS/RDGL version of "Helpful Hints from Heloise". It will be beyond huge and published sometime prior to the 12th of never.... Patience..