Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Realist vs Optimist?

We'll see.

Regarding your timeline

Best case we get cohort 1, 2L+ EGFRexon20 approved in the US some time in 2021

If you use a Rolontis clinical trial to BLA ‘waiting for Godot’ timeline lens on pozi, your timeline is accurate. It was no fun hearing since 2017 that they were getting EU sites for pozi up in running and finally getting them in ~Dec 2018 (probably the last patients dosed). But all pts in the cohort were dosed by the beginning of the year and they should have 6m DoR by early Aug and ~ 4 scans / ORRs in the bag so I couldn’t see why they don’t get an NDA submitted by the end of the year. Hopefully, having a CMO on board will keep timelines accountable. Heck, I’m hoping we hear that they got BTD using the previously treated EGFRexon20in cohort. I previously guesstimated that they recruited around half their pts by June 2018 (post 2504); that’s 44 patients. I’m hoping that they can use that data to reapply for BTD. The Z20 data should be more robust using ITT patients and not the evaluable patients LTFU in the MDACC trial. Not expected, we are talking Spectrum here, but very doable and would be a nice surprise. That would also set the wheels on a much earlier approval. If you look at brigatinib approval

They planned their pre NDA meeting 2.6 months after the last patient was enrolled and planned their NDA submission 5 months after the last patient enrolled. – post 2331

So the optimist in me says they can’t continue to screw up attainable timelines but the realist in you says “show me”. I get that.