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.
He is obviously talking about the CE-Melphalan aproval decision, not an NDA submission. The PDUFA data is this Friday.
Not a huge action, but certainly could be a tradable event if that was the reason for yek's question.
The FDA does not release the news (well, they will post an approval a couple days later).
The FDA will inform the company confidentially durring normal business hours, so very likely after the markets open. SPPI could release during the day (likely with a brief halt for new). Or they could wait till EOD.
A) Taxes. Neither pay any, but DL has to account foe them as losses because they have their credits on the books as assets (they reversed the writeoff 2 years ago). AA does not account for them as losses as their credits are still written off (they will likely revese this in a few Q). That was a difference of $860M in Q3
B) DL took a huge hit on fuel hedges in Q4/Q1 when the price dropped (the other airlines were not as heavily hedged). Right or wrong the market tends to discount these one time "oops".
clinicaltrials,gov says this month for the primary results to be in (that does not always mean released though).
CNAT says Q3
That would imply this week or early next week.
Note that unlike some trials where this is an estimate, CNAT knew exactly when the final data point would be available once the last patient enrolled. They updated these times a few months ago (after enrollment complete), so they should be accurate. At worst a fews days into Oct.
There is no news flow in the picture till late winter or so (P3 trial launch and CHF results). No partner or buyout (else they would not have sold shares).
Possibly somebody of note is buying shares. Possibly the quick financing left some "shorting into the deal" guys getting their deserved ass-kicking. Could also be mo-mo lemmings on the run (with or w/o some rag prodding them).
All just idle speculation.
Expect this board to start going into hibernation soon. Hopefully wake up to a really fine spring day next year :-)
TRVN's pain drug is (or hopes to be) a better opioid. It could well replace a good chunk of the morphine market, but is still more or less the same.
M Fool is 100% worthless on dev stage bios (maybe they have some value on companies that can be valued from financials alone, don't know). And they can be equally off base either pro or con.
There is no takeover in discussion. That is obvious, as they would have not diluted their own shares if that was the case.
The pop back is likely just a recover from the pre financing selloff. All kind of confusing with the timeline so compressed, but the trial news really was good.
I have serious doubts that the Fool can move a stock.
And why would that be?
That another HIF agent works should not be surprising to anybody. So far, it is unclear if they are just a "me too" that is a few years back on the development timeline.
It is simply impossible that ABKA can run the P3 trials (probably N 5000) w/o a partner, so we shall shortly see how BP sees this playing out.