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12:53
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Originally posted by JB1975:
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The second announcement I circled a paragraph. The first is the request for more data from the FDA. No mention that they need new data. requires because it seems you thinks needs and requires are different?and requires more data to support marketing approval"The reason that I tagged you is that from what I understand is that you believe that the only possible way to provide data is to create new data from the then proposed trial in adults. Oooookay.. That is near enough.The FDA do not agree with you. They have apparently been dumped down according to your standards. now , aren't you? The second announcement I circled a paragraph. "FDA noted that the lack of of a suitable potency assay for the RYONCIL product used during the Phase 3 trial MSB-GVHD001 for the pediatric acute GVHD indication has prevented the trial from being considered an adequate study for the purpose of demonstrating substantial evidence of effectiveness required for a marketing approval. " The final decision of the FDA to CRL 2 . Yes. SI then goes on and quoted the regulation . "Mesoblast intends to generate in the coming months new potency assay data for RYONCIL showing that the product used during the pediatric Phase 3 trial MSB-GVHD001 was standardized as to its identity, strength, quality, purity and dosage form to give significance to the results of the investigation as described in the Code of Federal Regulations for adequate and well controlled studies (21 CFR 314.126), and that the commercial batches made for the pediatric indication will meet the same standard" As you think that you are all over our patents could I suggest that you re-examine that chart with the 11 points on it. You have missed the bleating obvious . Hint it is not what you can see, its what you cannot.
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Requiring NEW is just your assumption.
(20min delay)