The back and forth between rvv and the fda for the past 6+ months has been extremely odd.
They were supposedly engaging in mutual consultations re the type c meeting to come to an agreed submission but lo and behold the most recent submission was once again deemed lacking in certain areas so its back to the drawing board as is said.
The question is, whos to '''blame"", per say, for past failings, and this most recent shortcoming......is the process being deliberately slow walked for some unknown reason???
Is it that the rvv med team keeps misunderstanding/ignoring the fda's instructions because of ineptitude, or is it that the fda is being vague and as such keeps using this confusion as cover to continuously "raise the bar" re the ep change???
IMO, the fda could simply state exactly what they expect from the submission, which rvv could then incorporate and then present for review so the process could then move to the data review stage.
Again IMO, it simply makes no sense why such a basic step is being prolonged for this length of time, especially when one looks at how much more complex issues (involving BP) have previously been rubber stamped.
Finally per your question, only time will tell since answering that would require actual insight into interactions between both parties, which none of us have.
@white chocolate 250.................was denied a $1M loan by the bank....but was told go add some zeroes to my assets and come back for review. lololololssssss
"Denied" (Deny) is a Synonym of "Turned Down" so you basically did state that the fda Denied rvv.........FALSE!!!!
SYNONYM: a word or phrase that has the same or nearly the same meaning as another word or phrase.
English 101....................
