Agree with you for the most part.
I do think though that the info that the liver enzyme levels were declining after discontinuation is a very positive signal that it might not be as bad as feared.
Had they started up on trial and just gone up, that would be bad. Also the bilirubin levels did not rise until after discontinuation.
Not saying that these make the drug look clean, just that the converse would have been the end of the story on the drug. So the story has been somewhat de-risked.
FYI, clinicaltrials.gov is the "go to" site for finding this type information.
As to the broader question about how long drugs stay in P2, it varies in the extreme. Not only is it the time for executing trials, but often one needs to tweek the dose/indication to find what works. So one might see several P2s before a P3.
Kind of weird that you are doing so well with such a divirsified portfolio, but seam to be non stop whining about a loss in one stock.
You made a dumb decision to buy into SPPI when it was riding an artificial revenue bubble that everybody knew had to burst. You should have waited, and then would be well up.
But it should only have been a small portion of your portfolio, so what is the big deal? We all get smacked down on biotechs at time.
I would certainly hope a treatment for toe fungus is safe.
I think the real question will be if docs/patients decide that not having to go in every month for 1/2 year or so to have their nails cut out makes for a better commercial product than "that other drug" to get approved about the same time.
BTW, no moon shot here on this drug. Perhaps the psorisis drug can be a big winner, but that is out a ways.
Realistically, we are playing "small ball".
The primary endpoint was 24 week response rate, and was stat sig WORSE at 4.6% for Allovectin vs 12.3% for DTIC.. That is a HUGE miss.
This number was know for a long time and never revealed to investors.
The CEO and certain buddies should be wearing orange.
Nope, the impairment charge reflects the loss in value due to the port collapse, not a sell for a lower amount.
When the sale occurs they will record the amount over the now lower book vale ($36M) as earnings.
If one simply sells an asset at less than book, this is simply a loss. There is no need for an impairment charge as the sell accounts for the fair asset value.
The fact that they took an impairment charge on an asset means that they have NOT sold the asset as of that Q.
This is (AFAIAC) a completely insignificant transaction. But the earnings (or loss) get recorded when the deal closes. And that DID NOT happen in the financials you quote.
What you posted makes little sense, so I also would like to know what you are talking about.
Drugs that are under patent are already protected against generic infringement by the patent. And "exact" same ingredients is clearly not possible. No 2 pills by the same manufacturer are exactly the same.
Perhaps this is a garbled of restatement of the Senate vote to restrict "pay for delay"?
IMGN/Roche's T-DM1 is a certain blockbuster. SGEN's 35 (Adcetris) is a very good drug, albeit in a smaller indication.
More will come.
It comes and goes. The run over this year has been so big you knew this was coming.
Just do not get depressed and take that job supplying feed-stock to bio-reactors :-)
Seams more like biotechs just being very "twichy" right now, and anything can set off selling. The volume is too low to be any real leaked news.
Perhaps some were speculating on an Oct CHMP. Perhaps some fund is liquidating biotechs in mass. Who knows.
I just doubled up on this drop (after getting back in on the drop last week). So sure hope it is just random selling.
Only one P3, but one of the P2s is pivitol (which is effectively the same as a P3 for us). And one more P3 early next year.
Also, the other MCK inhibitor (162) is in 3 P3s, 2 run by NVS and one by ARRY (though on NVS's dime). And NVS has a bunch of other P2 trials on that one.
Many, many shots on goal here.
FYI, Ratcliff has not been selling his shares.
He is the principal owner of a biotech fund. This fund invested other peoples money in ARRY (and I assume that is how he got his seat on the board). It is that fund that is selling.
There is a huge difference between a fund reducing their position (which could have many reasons) and an individual director selling on this scale.
FYI, gains from short sell profits are always short term, never long term cap gains.
This trial/indication/NDA should be fairly low hanging fruit (easy to get approved), Melphalan is the standard agent in this, and the captisol formulations are not new.
The real question on this product will be on the marketing side. Will it carry much of a premium price (relative to melphalan), and if so, what market share?
I assume we will have data in early spring, but it should be near meaningless (at least the part we see).
And to those making points about DOWN 20% 30% 40% 50% - show me a screen shot of your ACTUAL personal loses.
It means squat to say SPPI is down 20% 30% 40% 50% unless YOU lost 20% 30% 40% 50%
So if you can't PROVE that YOU incurred those losses, don't even cry - your comments are WORTHLESS
Winners don't appreciate FALSEHOOD posts when we are UP 300% 400% 500% 600%
Seriously though, this gets boorish.
Maybe. But also the ASH abstaracts are public in 2 weeks (had missed that earlier).
Just bought my Nov $18 calls back, even made lunch money on them :-)
They were looking at the PK/PD data to see this. Seams reasonable, but a VERY minor tweek that is not worth time discussing. Call me a skeptic on this being other than a distraction.
But on the good side, was it known Sanofi had this much to present at ASH (Dec) on our drugs?
I will not sell Dec calls.
Sold those against my entire position, so hope nothing big happens for a few weeks.
I think the options price the volatility way to high. I have been selling both calls and puts for several months now. Doing well.