Friday, November 10, 2017 12:21:49 PM
I get the impression you are not very familiar with the 351k process. It's not like 505j or 505b2 where a simple PK can act as a bridging study. Let me just say, it's much much more complicated.
I think part of the problem may be that SPPI themselves do not understand the complexity. The patent dance needed to allow biggy-backing existing GCSF data is a labyrinth and SPPI (especially their CMC group) has absolutely no bandwidth to support this. It's like little Timmy dreaming about going to the moon with his toy Saturn rocket..
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