Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

351a is the normal BLA process whereas 351k is for biosimilars so the 351a process would be a good thing. What you might be upset about, at least I am, is thinking that Dr. Raj telling us that with the BLA only 1 pivotal study was needed whereas it looks like 2 are needed. I’m upset with this (~6 month?) delay but I don’t think we can pin it on Dr. Raj (I would call him just plain old Raj (not Dr) if I was upset with him). Somehow, they thought that by getting a SPA for the ADVANCE trial the RECOVER trial wasn’t needed and (I’m reading into what JT said at Jeffries 2017 Global HCC on June 6) and that the P2 trial would suffice in lieu of the RECOVER trial. I suspect whoever made this blunder doesn’t work for Spectrum anymore. I wonder if that was a reason that Lee Allen, CMO, left on Jan 5, 2016, the timeline kind of fits as per post 1931. Sometime between Dr Allen resigning and the 4th Q 2016 CC we 1st heard of Zane Yang - Senior Vice President, Clinical Development. Regardless of speculation on whether Lee Allen had anything to do with the blunder I think Zane Yang is the fix to this happening in the future.