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antihama

04/25/18 4:01 PM

#2156 RE: Ville #2154

Yeah, I agree.

I think ASCO would have made a great venue to give greater details on top line results. They did say they applied for a presentation at ASCO during the RBC CC back in February so I don’t know why it would not be accepted. This drug seems to be jinxed. I've posted numerous times how I am pissed about the delay in submitting the BLA by nearly a year (so far) to the point I sounded like a broken record and said I was going to stop doing that. Back in 2016, at the CCs (RBC 2.24.16, Merrill Lynch 5.10.16, Jefferies 6.10.16…ok, I’ll stop there) they were saying Rolontis would be in the market by late 2018 or early 2019 and now they are saying late 2019 (and giving them the benefit of the doubt that it will be by then). Errr. This delay is one of the possible reasons I come up with why Raj is not CEO. Before Analysts Day back in March 2015 they used to talk of needing 2 - 500 pt studies, then they said they only needed one, and now it’s back to two trials; someone screwed up.

OK, I am not going to end this post on a bad note, I am going to imagine (more of a fantasy really) that JT doesn’t want to give a way his secrets as he mentioned at RBC Capital mkts CC on marketing Rolontis and by providing detailed data on the ADVANCE trial, Amgen et al will find out that Rolontis met statistical significance on the superiority test which would be a surprise since it only met SS for the 1st cycle in the P2 trial but since there are 5 times as many patients in the P3 trial it was able to meet SS in cycles 2 through 4 also. Now that would be extremely positive. It’s good to dream but that is a fantasy by any stretch of the imagination.
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antihama

05/03/18 4:13 PM

#2170 RE: Ville #2154

Ville, good news on Rolontis abstract at ASCO! From the 1st Q Financial Results PR

ROLONTIS® (eflapegrastim)Phase 3 data abstract to be released by American Society of Clinical Oncology (ASCO) followed by an oral presentation at Multinational Association of Supportive Care in Cancer (MASCC) in June 2018.