Didn't change my story. Was clear from content what I meant, Animal tests haven't started. Never suggested they should have started before 3rd meeting. Fact remains, tests have yet to start.
Again, point is RDGL hasn't requested FDA consider Radiogel human trials. That is a fact. Ball remains with RDGL to do so.
EFS is a pre-submission discussion program only. Been very clear from get-go, RDGL still has to submit an IDE application if they wish Radiogel to be considered for human trials. The discussion program concludes when FDA says so, not before.
RDGL has no such containment data of any kind on current version of Radiogel. Yes, they have data on prior version with rabbits (not dogs or cats per publications from RDGL), but Radiogel is now made under different process and with different polymer than prior version.
FDA has been suggesting this containment testing from get-go. Obviously, whatever data MK presented at first and second meetings was deemed insufficient. Don't have to be at any meeting to know that. That's all one needs to know about why FDA suggested more tests. FDA been very clear: no PET scan containment data = weak unlikely to be approved IDE application. Is what it is. Only question is why couldn't MK not resist FDA, suck it up and get job done? Test would have been done long ago had he not resisted. Now with the delays, we're looking at massive dilution early in 2023.
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