Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

What is the 'Till EOY #1 news event'? Excluding the Sept 24th live update, of course. Is it

a) BTD in EGFR metastatic ex20in
b) BTD in EGFR AND HER2 metastatic ex20in
c) BTD in EGFR 1st-line patients
d) pan EGFR/HER2 ex20in trial started by MD Anderson
e) Rolontis BLA submission
e) None of the above

My answer is e) None of the above although it would definitely be c) BTD in EGFR 1st-line patients if that were to occur but this is so highly unlikely, i.e. mostly musings on my part, and not getting my vote. It is in the realm of possibility, however. as I remember Dr Raj saying in early 2017, we can petition the FDA for BTD with data on 10 patients. Well, if 35% of the patients were in 1st and 2nd-line, that's 14 patients, there is a slim possibility it could happen. As I said just musings more than anything else. Regarding a) BTD in EGFR metastatic ex20in, well, it's significant but we kind of expect that, and regarding b) BTD in EGFR AND HER2 metastatic ex20in, the HER2 part of that would be a little bit of a shocker. Regarding d) pan EGFR/HER2 ex20in trial started by MD Anderson, well that's kind of expected. As for e) Rolontis BLA submission, well, Rolontis doesn't get much love compared to pozi and Spectrum has been saying for the last year or so, 'it will be submitted in the 14th Q of 2018 (note-In the spring of 2016 they were saying BLA submittal in 2017) So if the submitted it on Oct 1st, well, that gets an honorable mention plus plus.

So my answer to the #1 news event would be, for before the end of the year, if we heard it, is that they stopped recruiting for SPPIs EGFR cohort. Why? It's because that's what will start the clock ticking towards approval. Of course the data needs to mature but it starts the clock ticking. BTD will make it much smoother sailing but we need that data. Hopefully this year we hear about that.