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CRIS BCC trial wasn't phase 3 trial. It was single arm phase 2 trial.
I think it is a really stupid analysis, honestly.
Regardless of this persons personal financial situation, he should, at the very least, have a basic understanding of biology and the fact that both drugs are entirely different. And, well, actually pronounce the drug names correctly.
it sucks this type of crap is allowed on Seeking Alpha.
For a seriously hearty laugh, please watch this
Yes, I took profits in ARIA. A little lower, between 15.60 and 14.55. I would be a buyer on strength again, as I still think the stock has a lot of upside (or, contrarily, on big macro weakness). '113 really is the key to another 10 point leg up; and, a hostile bid is always on the table - its really one of only a couple companies out there that have huge potential. I basically took profits because I want to wait and see what happens....and It was a great trade from the August lows. Still have a little though.
As far as CRIS. I truly believe the stock should be at least valued at 8-10 alone on their first drug, GDC-0449 (Erivedge). The BCC indication alone is actually a lot bigger than they are getting credit for right now. They got a broad FDA label on the drug which actually gives Doctors to possibly prescribe it in Gorlins patients and some operable cases as well. Theres a potential of 20k patients a year here... $7,500/month x 10 mos. IF they show any success in pacreatic, gastroesophogeal, or SCLC, or sarcoma, tack on another 500 million to $1 billion potential. GDC-0449 has the potential to be a $2 billion drug. The market is essentially giving no value to CUDC-101, or their three other compounds....its kind of a joke. CUDC-101 has the potential to begin a registration Phase 2 trial early next year....and it is given no value even though it has shown some really good early responses in refractory head and neck, and also refractory liver tumors. They also have a PI3K compound, and an HSP90 drug partnered with Debio which has shown some activity in NSCLC. All for a market cap of $350 million.
The only reason FMR, Wellington, etc., Baker, Sectoral, are not big in the name (IMO) is because its a lot easier to pick up a large chunk of stock in a financing, than it is to go to the open market. Look at their institutional ownership - for a company with a large revenue source in royalties going forward, and three other drugs, Sectoral, Baker Bros, FMR, Wellington, BB Biotech, Orbimed, BVF....none of these guys are in the name yet. No onwership at all. You want to be in before the start to pile in....IMO.
OMG! Bear raid!
lol
Amazing the almost exact correlation between the IBB and ARIA going back into the August time-frame.
AACR--you're not a fan of xenografts, petri-dish, and mouse models?
BMO research report..CURIS
http://research-us.bmocapitalmarkets.com/documents/AB3D40F5-3FED-4213-8D09-395A2649875D.PDF
It's actually called "Jenzyl" in Europe!
(Ridaforolimus aka Taltorvic)
Dew, do you like the name "Jenzyl" better? Looks like that is the Euro name given to the drug (see last page)
http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/03/WC500123528.pdf
They have some trials going on with MK-2206 (Akt) that will probably do well. Akt is somewhere along the PI3K
http://clinicaltrials.gov/ct2/show/NCT01295632
I think going forward these will probably bear some fruit - but - not before Ariad probably has a lot more data on '113 so all this will be relatively meaningless in the scope of things.
I never really liked ridaforolimus. The combo trials will be were it shows its true efficacy.
The most likely to see results in will be the BC study (DALO+RIDA).
I'm also assuming that ARIAD will also incur somewhat higher sales/marketing expenses as Merck would have compensated Ariad for up to 20 percent of its US sales efforts under the co-promotion agreement.
L-M-F-A-O !!!!!!!
Sureeeeee it is.
BTW, if this ever did go to that level, I would sell every single other one of my holdings and buy ARIA.
I would love to buy ARIA at $12. I would be psyched--unless the macro picture gets bad or we have some general US b.s. shakeup on some stupid macro event, I don't see the U.S. market as having a bad year. In fact, equities are really the only asset class to own at this point--after underperforming for 10 freaking years (at least now).
As far as CRIS, read the Seeking Alpha article. Company has a mega-Donkey for a CEO. So, hopefully the data will speak for itself and make this Donkey CEO irrelevant--I would love to see Roche just buy them (wishful thinking).
The ONLY reason I can see this selling off is because analysts will likely have to take down their YE cash models etc., because they had built in approval monies and royalties etc. for the sarcoma indication.
This would be a disaster if they didnt have Ponatinib and '113---instead, its likely to be a non-event and a reason for people to step up buying before Ponatinib data in June.
LOL! Harvey is THE MAN.
He pawned this POS mTOR off on Merck for, what... $150 million?
I'm sorta disappointed it's only down 30 cents on this panel vote. I was really hoping to pick some up around the 200 DMA.
Oh well.
P.S. Dont forget all the other Rida trials---even though those are years off. At least they will likely show real efficacy--they're in combo with other drugs--just the way science says the drug will work best.
CRIS
6 pancreatic cancer studies with NCI/RHHBY/ and independent sponsors
http://seekingalpha.com/article/445871-curis-potential-blockbuster-application-in-pancreatic-cancer?source=yahoo
LOL, but you left out the letter “r” preceding the “v”, which is essential for identifying the drug as a member of the mTOR class :- )
Where are you looking for a re-entry?
I think Taltovic would have been a "sick" monster that Godzilla could have fought on Creature Double Feature.
I think its your imagination.
He's a terrible CEO, and B. Riley is just getting around to figuring this out.
Anthera Halts VISTA-16 Clinical Study Due to Lack of Efficacy Following Recommendation by the Independent Data Safety Monitoring Board
* Halts Vista-16 clinical study due to lack of efficacy following
recommendation by the independent data safety monitoring board
* Dsmb's recommendation based on review of totality of safety and efficacy data
available for the Vista-16 clinical study
* Closed enrollment in phase 3 Vista-16 clinical study & informed investigators
to remove patients from therapy
Short Interest
Interesting that the short interest DECREASE 14% from 2-15 to 2-29
12.6m vs 14.6m prior period
Another piece of Ariad that analyst community is giving zero value to (do they even know it exists??????)
I wonder if she will upgrade px tgt to $28 when ARIA is trading at $26.
Nice find
Great report, thanks.
As I have said before, there is practically zero market cap value being ascribed to '113 right now. You can tack on, very conservatively, another $1.5 billion if '113 has a showing like '534 did, early on.
Rachel says;
An estimated 30% of Xalkori failures with have non-ALK related mechanisms of
resistance, including EGFR, Kras, Kit, and Her2 related according to experts.
Therefore second generation ALK inhibitors are not expected to demonstrate in this segment.
---does she understand 113 hits EGFR?
Would you rather give "X"% away in a partnership, or keep 100% of the rights, and increase outstanding shares?
Either one leads to increase in price of the equity (generally), but keeping 100% of the rights leads to big long term value (assuming the results are good). Case in point: I was a little irritated that Ariad's Berger kept financing instead of partnering Ponatinib, but, right now, it's looking like a really good move (assuming he can pull off commercialization of the drug). I don't think Ariad would be valued as high as $2.2 BILLION right now if they only had 50% of the rights to Ponatinib - but, I could be wrong!
I think that Celldex' capital structure can allow it to issue more equity at reasonable levels, for at least a while.
The company isnt a bloated pig like a lot of biotechs. They have around 50 million shares outstanding. They have room. I dont think they really NEED to partner 011 - they could always do financings at higher prices assuming the results will do the heavy lifting for them.
If Stimuvax was "inert" (HR=1) would the DSMB have definitely halted for futility at this 2IA?
What HR level would generally be an average for an efficacy halt at 3/4 event? ....basically, making it impossible for any type of final positive result?
thanks
Completely agree with this.
The halt really screwed about things here, IMO. Dropouts, adds, etc., etc, make it impossible to figure out anything, and, what you have here now, is a crapshoot IMO.
How will you ever even find the answer?
Kirkman is an idiot, and Merck doesn't say boo.
I did catch that. IMO, the halt for the death really screwed up the events and timing of this trial, making all assumptions in stat analysis entirely irrelevant (if stat analysis wasnt already).
Too many variables to map out anything, too many unknowns.
I still think this has a very good shot at showing statistical significance in the final analysis, albeit, along the lines of what Dew said -----not, a knock the cover off the ball type of showing.
As I asked someone else, is it possible that you could have had a 6 month OS advantage at the 2IA, and still not have reach an SPA endpoint because the p - and HR was too high of a hurdle?
Yes, they're moving px-866 into the HCV nuke space
(lol)