Spectrum Pharmaceutecals Inc (SPPI)

[stugwins]

Oder? are you German?

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..