Monday, November 13, 2017 12:02:20 PM
Please do some research on 351a and 351k. If they pursue 351a and wish to bridge to the Korean data then the major issue is not that much the bridging but the quality of the Korean data.
i.e. How far did Hanmi go with clinical trials? (my understanding is not far past phase 1). Were the clinical trials of acceptable quality to meet FDA standards? (i.e. even if they bridge, will the FDA accept the data?). How about CMC? (i.e. analytical methods, process, scale-up etc?. I assume you know that in Biologics this is much much more important than in small molecules).
The old "magician" my be good at confusing the less sophisticated but reality will catch up with him...Unless serendipity helps again the way it did with Levoleucovorin a few years ago...
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