For this latest submission they were definitely communicating re the type c meeting but prior to that there may have been but imo it would have been limited.
As I previously mentioned, either the rvv med team is simply inept at comprehending what the fda requires, or the fda is constantly moving the goal posts re what they require for approval of the ep submission.
I can think of no reasons why rvv would deliberately want to continuously delay the process by providing substandard submissions.
There is no present need for additional trial data, nor do I believe that any data from dr fahy's research at ucsf will have little impact on the ep change request so a desire for delays is simply not there.
I am tending to believe that the fda (among others) is at the root of this obvious farce and that the link below possibly indicates the reason why................
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