I think you are over stating what Doc said. I understood it to mean that the obligation is on MSB to approach the FDA iron out any specific concerns about the trial protocol, and not the other way around. MSB has in fact on more than one occasion approached the FDA and been granted approval to make changes to the protocols or end points. So they know the process. If they do so without consulting the FDA then that isn't illegal but they run the risk of problems later.
Ann: 36-Month Results of Phase 3 Trial in Chronic Low Back Pain, page-133
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