Well, I could care less about IR, but they have several big events the near future.
. SELECT-1, P3 selumetnib in NSCLC any day now.
. COLUMBUS. P3 binimeinib+encorafenib BRAF melanoma likely this month
FDA acceptance of NDA in NRAS melanoma later this month
Perhaps regulatory path for 797 "sometime".
Perhaps some early stuff, but the bullet list are the PPS drivers.
On further review they have launched a 2nd line trial for any solid cancer that expresses TRK fusions (the target of the agent). N=151 and results expected Spring '18. Could well produce data that could generate some excitement.
Yes, that is a ways to go. But the FDA "Break Through Designation" is on the drug, not the trial. It is the enhanced version of Fast Track.
And correction to my original spelling. The drug is LOXO-101 and the company is Loxo Oncology.
I am not negative here at all, just never consider any such submission a "shoe in" and always look for flaws.
Interesting side point to your statement. The prior immuno subgroup would not be subject to the effect you mention. And those did show a good OS trend. Kind of backs you up.
I do not think the FDA would take any such argument as anything other than hypothesis forming. But they do not need OS for approval, and this type argument is enough for the FDA to accept that the OS data is not a flaw.
Hopefully we will see this story start playing out real well over the next year. Been a long time :-)
ARRY has double digit royalties 380. Here are the revised terms:
Development and Collaboration Agreement under which Oncothyreon and Array were jointly developing ARRY-380. As part of the License Agreement, Oncothyreon paid Array $20 million as an up-front fee. In addition, Oncothyreon will pay Array a significant portion of any payments received from sublicensing ARRY-380 rights. If Oncothyreon is acquired within three years of the effective date of the current agreement, Array will be eligible for up to $280 million in commercial milestone payments. Array is also entitled to receive up to a double-digit royalty based on net sales of ARRY-380.
Rare for FDA to restrict label based on subgroup analisys. The only time I have seen this is in the case of a targeted agent where the subgroup was very obviously likely to be real.
I think the subgroup data here is more just confirmation that Bini works in a post C/I world.
Am very positive here, but do hope that OS curve gets a little better liking with more data.
No. It means that the FDA first and formost looks at the PFS data which was statsig positive. This was what the trial was designed to prove, and is an approvable endpoint. That is good.
That said, the FDA will not ignore that the OS data was not good at all.
The HR of 1.0 for OS is a serious concern. Am long and like the prospects, but the FDA will raise this as an issue (unless it improves as the data matures)
One advantage of living in Denver is you can take the weekend for a hiking trip up in the Rockies to clear your head. And I would suggest such.
The trial halt was called because the patients with Neuvax were eventing faster than those on placebo. That is the entire story on the trial.
It does not matter at all what data they mine from the failure to try to sell stock to fools. The trial failed, and failed badly.
To protect the blind in case the sponsor decides to continue the trial.
The DMC is making a recommendation, the actual decision is up to the sponsor (though or course the FDA might want to get involved). But the sponsor can not make a rational decision w/o seeing unblinded data.
SO, the sponsor will pick a few individuals to go over the data and decide. If by some chance they were to decide to continue, then the blind would still be maintained (though the individuals would have to remain apart from the ongoing trial).
I am NOT saying that is likely here, just saying that is what the IDMC means.
It is very common. Fast track says nothing about odds of success. Off the top of my head:
PPHM's SUNRISE trial failed for futility a few months ago with Fast Track
CLDX's Rindopepimut failed for futility a few months ago with break through designation (an enhanced version of fast Track).
The designations mean that the drug, if it works, would be a significant improvement in a serious condition. They do not say anything at all about high likely it is the drugs will work.
Hopefully you have learned not to byte on the fast track (or orphan) hype.
. If you have sold the stock, it is a cap gain in the year you get the check.
. if you have not sold the stock, it adjusts the basis and will factor in when you sell.
The 5.5 vs 1.6 data is in the N=85 subgroup who had 1st line immo agents, not the ITT population. This is important because one would expect such to be almost all prior treatment in the future. This should certainly help uptake once approved.
Also, all the listed subgroups were solid on PFS.
ORR came in at 15% vs 7%.
The preliminary OS was trending at an HR of .81, kind of "meh", hopefully this number can improve a bit with age.
Submission next month. Hopefully a fast turn by the FDA might see an approval by about EOY (ok, I know one should never expect such).
The '8689 trial is single arm.
PFS can be used (in some indications) with a controlled trial because one can compare X months to Y months and see how much better the new drug is.
In a single arm trial, what does PFS mean? Is 8 months good? Bad? Who knows? Historical comps are meaningless, so there is no becnhmark.
An approval based on a SINGLE ARM trial with PFS would be total BS. And such in the US/EU/Japan would simply never happen.
Admittedly I do not follow the S Korean drug development scene, but this sounds like a bunch of nonsense.
. The trial closed enrollment a few months ago, and the primary endpoint is +12 months. So early next year for data, and that is what is posted.
. PFS for a single arm trial would not be considered for approval by any legit body. Basic issue is that one can not compare time based data to historical norms, and w/o such there is nothing to go on.
. Changing the N well into an open label trial is more than a minor problem.
Oh, the drug might well be approved over there. But this would say more for Hanmi's family ties than the strength of clinical evidence.