Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

OK, it's official in my book, 2 trials are needed to file the BLA. In addition to JT stating at the 3rd Q CC

RECOVER study is an international study that will enroll around 218 patients from Europe, the U.S. and other selected countries. This study is enrolling well and should yield results next year in time for us to file a BLA for ROLONTIS in the fourth quarter of 2018.

He discussed it more elaborately at the Jeffries 2017 Global HCC on June 6 where he also talked about the P2 trial and mentions that because it wasn't randomized and pre-considered they couldn't use it. Sounds like someone screwed up to me in not submitting the BLA 6 months earlier (i.e. 2 Qtr 2018)

Regarding the PK studies, the Korean study is in healthy pts while the current PK trial is cancer pts receiving chemo. I'm sure it's definitely needed but not the cause of any delay.