Are you realy that dumb?
Apparently so
The first is the request for more data from the FDA. No mention that they need new data. 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. The FDA do not agree with you. They have apparently been dumped down according to your standards.
The second announcement I circled a paragraph. The final decision of the FDA to CRL 2 . Not important apparently ,catch up. SI then goes on and quoted the regulation .
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.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-932
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