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14:27
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Originally posted by col69
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I will add that Mesoblast provided a lot more information than I expected them to today about the FDA/ CRL and the upcoming Type A meeting, which as noted is already booked in .....We believe that we can link the product that was made in the Phase 3 trial to the current commercially risk product through additional work using potency data. The FDA indicates that an additional trial would be needed to establish this link, if the Company is not able to do so via the additional potency assay work that is currently expected to be initiated. The Type A meeting with the FDA is scheduled to be held in mid-September, and we will be laying out these exact strategies. We proposed providing FDA with additional potency assay data to provide the link between Phase 3 product and the current commercial inventory. We also proposed providing FDA with new clinical trial data in adults, which could also support the pediatric indication .
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