Friday, June 08, 2018 6:35:49 AM
Just listened to it last night and I can see why the SP has moved up a buck or so after the CC. Not much that JT has said was new but he did reinforce everything we knew in in a positive manner mostly by reinforcing everything is going smoothly w pozi and Rolontis. He did mention that they have 30 sites up in the US and that his team was in the EU a couple of weeks ago to open pozi sites which we knew from the Merrill Lynch CC 3 weeks ago. My only concern with this is that I hope that in waiting for international patients to participate in the trial it won’t delay any timelines. He reiterated it’s ‘up to’ 87 patients per cohort but if you need international patients we still have to wait for them to participate. No? He discussed the BTD process timeline further and you get the feeling SPPI will have the required data soon (full 1 year data for the 1st 11 patients??). Also, on the pozi front he discussed the pan HER2 exon 20 mutation trial protocol is being reviewed by MDAs IRB. So, like the NSCLC study they will be taking the lead on pan HER2. Hopefully MDA will be leading a multi-site trial which I believe is a necessity (but don’t know for sure) for approval since it stands to reason that MDAs NSCLC trial would have fulfilled the requirement for approval but Spectrum went ahead and started a multi-site trial. The one Q I have on this is they only refer to HER2. What about EGFR? Is that part of what they are talking about? Is MDAs Dr. Robichaux still working on getting EGFR pre-clinical data? I guess we’ll find out soon enough.
Regarding Rolontis everything seems to be proceeding to current plan and JT reiterated his confidence that they’ll be competing strongly in that space with their marketing plan always expecting 2 biosims in the market. The one thing he said which I’ve said over and over through the years is that it won’t take much for Rolontis sales to impact Spectrum bottom line positively. Paraphrasing his (exact) words
Here's the CC link
http://wsw.com/webcast/jeff113/sppi/
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