The only way to prove that the 2x2 dose was the
optimum or not was to trial 2x2 alongside 1.5x2
or any other dosing regime in question. Are you
sure FDA requested that 2x2 not be included in
the dosing trial? That would seem very strange,
considering such large numbers of patients
(circa 600?) were treated in the dosing trial.
Additionally, around half of 002 patients will
not receive the proposed optimum dose. What a
waste. If the FDA did specifically prohibit the use
of 2x2 in the early part of the trial, then we have
nothing to worry about.
Ann: Paradigm Receives $7.36m R&D Tax Incentive Refund, page-45
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