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12:19
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Originally posted by Martin37:
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My take: in vitro potency assay to in vivo clinical outcomes (Point 2 above) MSB believes this will suffice in demonstrating Rem-L consistency in their Phase III study (i.e. standardised to identity, strength, quality, purity, and dosage form). in vitro immunomodulatory activity) then this can be linked to in vivo Phase III clinical outcomes demonstrated, therefore addressing the need for another trial (i.e. no need for another trial). From memory our trials were based on different products so to say. Initial Rem-L and then improved Rem-L after manufacturing improvements - resulting in product being more effective. Therefore not all our data compares apples to apples so to say (may make the FDA uncomfortable). It seems SI has addressed this by comparing patient outcomes on the two different batches and found the improved Rem-L had better patient results (and now has potency data to support this finding). From memory phase III primarily used improved Rem-L after manufacturing improvements (and a smaller amount of the older product pre-manufacturing improvements). in other words if above points can be established then SI believes there is no need for another trial.
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correct IMHO!
(20min delay)