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.
Those who continually mouth inane comments about hedge fund manipulation and naked shorting should probably stick to investing in large diversified funds.
My understanding is that a settlement/award would be treated as a reduction in basis. If you have already sold the stock, it would be a long term cap gain (well, actually the term would be from purchase to receipt of cash, but these things aways take years).
As far as the Fusilev shortage issue, you have to be joking. Fusilov sales spiked when the generic racemic mix had supply shortages. Did anybody really believe Raj when he said they would not return to normal upon resolution of the supply issues? Never short SPPI, but I did sell out that fall for exactly this reason.
What the OP has correctly noted is that E-Trade is misreporting the basis. For lots that are originally PCL they are reporting the new share count but the original price as the basis.
The effect is that ETrade is showing a substantial phantom loss. If this is also what they report to the IRS, makes things kind of fun.
The present share count and valuation is correct.
Can you point me to the sorce of that quote? I can not find it.
It might well be that the stability issue is the real driver, but I do know that reformulating to remove PG and its side effects is not uncommon.
Same here. I would hope they fix it before I sell (which might be years, I like the stock for income) and they would send it to the IRS.
The good news is that if something goes wrong and the tax basis never gets fixed, it is in our favor :-)