Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Exon 20 Mutation trial changes doesn't change anything! That is regarding timelines. When I first read about doubling # of pts in the trial to include HER2, I pondered (briefly) if it would delay readout. Of course it will delay the official close of the trial since you have to recruit new pts but as far as timelines not so much. Since it's an open label trial, they have a good idea of whether they have a winner or not. Say by end of year, they will have mostly mature data on the 25 - 30 EGFR patients and perhaps 10 -15 HER2 pts. They could still present that data at 2017 SABCS in Dec (and Dr. Raj did mention the possibility of presenting data on the 1st 10 pts when available). But more importantly, they'll have enough data on determining go/no go on a pivotal trial and to commence discussions with the FDA/ other regulatory authorities on a protocol for it. So I don't think they'll miss a beat. I also see that they'll have enough info to discuss with big pharma on a licencing deal for the EU. AstraZeneca's Tagrissa (post 1639) or Pfizer’s EGFR dacomitinib (post 1675) compete in the NSCLC mutation space but not for Exon 20 Insertion mutations. Except for Poziotinib, nobody seems to be touching that and I could see those pharmas adding poziotinib to their arsenal since they wouldn't need to add any more additional sales peeps than they already have.