Twinter11, yes , you are right , For this , prot
Post# of 158785
For this , protocol need to be amended as you posted , and so far what we know Dr Jay didn't try to amend it.. We will need application to FDA ,and new IRB . Not very difficult here IMO..
He said in the incoming meeting with FDA he will talk about it.
Well , it is little late , but lets hope !!.