Thursday, February 16, 2017 9:03:44 AM
I was musing about whether they would go there this year. They routinely present at this conference every year but was wondering what will they boast about and have they healed from the apaziquone NDA denial by the FDA? They really can’t get into specifics about whether they have good revenue #s for the 4th Q (which I think will be above analyst estimates) since they will PR/CC that in 3 weeks at the quarterly. I guess they could show confidence that Evomela sales are as good as hoped for or better than expectations. Or perhaps some news about the drug development front such as they expect to finish enrolling patients in the Rolontis or Poziotinib trial soon? One thing good is that I’m certain that they’ll address/ be asked Qs (hopefully we get to hear them as we did last year) on apaziquone. Better to get it out of the way than get slammed by it at the quarterly.
[Aside on apaz – there is always something in the back of my mind that w the Cures Act and new FDA head that they address some of the stubbornness of the FDA on making companies run expensive new studies when they can evaluate from existing large randomized double blind placebo controlled studies that failed, sub groups where the drug shows efficacy which Spectrum was able to show w Apaz. They did right by stopping the new P3 if they can’t market the drug now on conditional approval].
At last year’s conference Raj caused excitement by talking up the Korean P2 Poziotinib metastatic BC study as “Impressive” and even musing about Regulatory approval (in Korea). The open label study stopped recruiting on Feb 29, 2016 and the primary and secondary endpoints mature 1 year later which is about now. It would be exciting news if they mentioned that they could expect to PR topline data in the next month or 2 from Hamni / Spectrum and more details at ASCO in the beginning of June. In their last Presentation, the Korean study wasn’t referenced so I’m wondering about whether that’s a sign of anything. We’ll see but if nothing is heard by June then I don’t think the results were impressive.
Last year, the way the conference was structured was pretty good with Qs coming after the presentation, hopefully, they’ll continue w that format. All in all, I see Spectrum being at this conference as a nice positive since it seems like SPPI is healing form their almost mortal would that came about from the apaz NDA denial.
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