Still trying to understand why we have been forced to a low dose trial when the safety and tolerability has already been proven at a higher dose in the P2 MS trial? Why are we constrained by the FDA for a trial in Australia anyway? Shouldn't the TGA be having input into what happens here? and why are the EMA allowing a higher dose trial? I have seen this before with other Aust Bio's, I feel like the FDA are always batting for the home team and restricting Bio's in other countries from advancing.
Still trying to understand why we have been forced to a low dose...
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