I recall Donna mentioning something about going to regulatory agencies, possibly the FDA, with data at the 6 month readout to inquire about the requirements for DMOAD. This will also be a great time to get the FDA to agree on an appropriate surrogate endpoint and possible pathway for accelerated approval.
The results for pain and function also present an interesting dilemma for the dose selection component for PARA 002 stage 1, since the two weekly dosage of 2mg/kg is not offered, so we need to hope that 2 x 1.5 mg/kg achieves the same response.
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I recall Donna mentioning something about going to regulatory...
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