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 :-)
Yes wrt "nobody knows". But the March news will be one of:
. Carry on till completion (EOY or such)
This was an XML cleanup only. The entry prior to the change had a maximum age field that was blank, the change removed the field.
Look at the previous text version (click on updated before xxx) and you will see at the bootom of the Recruitment Information section:
minimu age: 18 years
healthy volunteers: no
And the exact same information after the change. No maximum age was previous there.
And as somebody else posted, the requirment is for recruitment. Does no effect those in the trial.
I would assume there is no milestone for the P3 success. First, trial success can be a slippery metric. Second, they have not announed it.
A reasonable expectency would be EMA approval as the next milestone. Something close to $100M? H1 '17 I would hope.
. As stanly said, they are likely to have selumetinib and 818 on the market by then.
. They will possibly have filanisib and 797 in pivitol trials then.
. They have a significant number of candidates (clinical and preclinical) licensed out to BP
. That Loxo deal might be interesting
. Who knows, mayby that dog we licensed to ONTY could bring in some cash.
The 2 MCK inhibitors, binimetinib (today's news) and selumetinib are both in dozens of trials. Many P2s and a few P3s.
Both these drugs had an odd history, ARRY partnered them, but because of mergers the partners had to return them with cash. They recently re-partnered both in EU (modest cash, decent royalties).
LGX818 (a BRAF inhibitor) they obtained recently obtained from Norvartis. It was being studied in conjunction with binimetinib, and other trials. In at least one P3.
Filanisib was their wholly owned Myeloma drug that they were pushing hard, but when the 2 MCKs were returned they have switched focus to those. It is about P3 ready.
Several other candidates floating around in earlier stages, some partnered,
A) They have not yet released OS numbers, so you have no idea what that is.
B) The comparator (Darcabazine) is particularly nasty.
C) Learn the difference be median and mean. It matters.
If you mean the trial data, it should be ready any day now.
Enrollment closed mid July, they are gathering 3 months of data. So even allowing a little slop it has been a month since they could have started putting it together. And it takes no time at all to analyse top line numbers.
It would do exactly the oppoiste to shorts as it does to a long.
For a long, it gives them a few extra pennies, but weakens the stock as it spends needed cash. Overall not really a good thing as they might then need to turn around and raise cash.
For shorts, they would have to pay the dividend. But more might be interested in shorting the stock as the impair future prospects.
Get out of all this "short", "manipulation", "MMs", "hedge funds" nonsense.
SPPI is where it is for a very simple clear reason. They are basically a specialty pharma that has seval low value drugs. It is not a dev stage biotech. As such, it has to show that it can make a real profit, and that it has failed to do.
P.S.: I do agree that the pipeline has some potential value beyond this. But given their reord to date, and some iffy questions, it is not going to valued in by the market.
So, you think the way to win is via illegal stock manipulation?
I assume from that you do not see MNKD as a viable company?
Well, I made some nice money here (on the long side). Not that it really matters.
But hoping somebody chokes and dies because you can not invest well? You are sick. Get help.
One has to assume that SPPI failed to produce a sufficient package on what should have been a fairly straightforward NDA. Proven drug moa in the indicatoin, proven re-formulation technology.
Perhaps the FDA tightened up on some issue unexpectedly, but far more likely SPPI was deficient in a way that a competant organisation would have avoided.
Hopefully just a minor issue that can get a reasonable quick submission and 6(?) months action date. Hopefully not a 2 year animal cancer study or such.
They said it is not clinical (which means the FDA is not claiming the trial was insufficient).
But that still leaves manufacturing and pre-clinical.
Manufacturing (CMC) is likely a minor issue. 3-6 months.
Pre-clinical could imply more rat-cancer data which is not a huge issue, but does certainly take time..
BTW, SPPI could most certainly release details and they did not. I would not be a buyer right now.