Avid Bioservices Inc (CDMO)

[DrRocker]

EB
I believe the path you have laid out here with a phase II/III trial design is both a plausible and likely scenario as it would give the FDA cover from all angles.
I think your quote below regarding explanations should this scenario come to pass is spot on as well.

However, in this case, the company had better to be ready for some explaining because there would be no need for such a design if the "clear evidence of dose switching" had not occurred. It would also prove that the FDA is not really sympathetic.