Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

CASI's PR is making a lot more sense to me now in light of the CFDAs acceptance of Overseas clinical trials. When I first read the PR, I wasn't quite sure what Evomela getting priority review meant. In FDA parlance that meant that a NDA was submitted and the clock is ticking for the regulatory agency to approve or reject, within a 6 month time frame. I didn't think it meant the same thing for China since before this change in the regs, CASI would have needed to do a trial in China before getting approval. In light of this change in the regs, it looks like priority review is what it says it is and that is...a priority review. Note that the wording is different for Zevalin and Marqibo where CASI expects to initiate the confirmatory trials. Still, even with Zevalin and Marqibo, I'm wondering if they still would need to initiate confirmatory trials in light of the change in the regulations.