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Nathan Michaud is now on Twitter as @InvestorsLive
FWIW
I truly do not understand how you can have a management team this stupid to develop a molecule highly targeted to a specific site, yet, no pre-stratify the trial(s).
This is either just complete incompetence, or the drug isn't truly doing what they claim it is supposed to do.
But they didn't pre-stratify this trial?
These guys are really bad at trial development.
Does anyone know if they spoke about c-MET high patients in this trial, on the conference call?
re SI Charity Contest.
Right now I'm bummed out about this. I actually had TGTX in there 10% weight...but then realized i left out ONTY and replaced it with ONTY.
$TGTX Anyone want to discuss their ublituximab CD20? I believe this is derived from goats (spun-out from former Genzyme company):
Since then, GTC has worked on an undisclosed new use for ATryn. It licensed a compound called ublituximab to TG Therapeutics Inc. as a possible treatment for cancer and autoimmune diseases.
It is very rare for Pazdur to make comments on drugs with such praise as he did for ponatinib. The academics know this is a very special drug, so do most doctors in the clinic (ones that a patient would want to be involved with, that is). IMO, this boxed warning is nothing more than semantics and the FDA covering their ass on all angles.
The odd thing about this company is Mark Schoenbaum of ISI is on the Board.
I have a very tiny speculative long position simply because of the hot PI3K-delta drug; yes, not data, all hype ---- which is why it's a tiny position. But Mike Weiss certainly fleeced many with Sulonex pumping that one with Keryx.
Sadly, Stimuvax will probably show very good benefits in these "prespecified subsets" (as they called them) for which they should have designed a better Phase 3 initially, and not figured this stuff out now.
But, assume the subsets are great. They cant go to the FDA with those...I assume they would get NOWHERE. so, they run another Phase 3 in that selected population, and the readout is.....what, 2017? By then, PD-1 and its derivatives will probably have made NSCLC something managable like HIV/AIDS. ....rendering Stimuvax, worthless.
-95%
Can you recall such a blowup? Hell, I thought -75% was bad prior to this one.
INFI was the result of a reverse merger.
I dont really care too much for Martin but I am interested in what the company does; lots of orphan stuff.
By the looks of the trading, its going to be nearly impossible to trade the stock unless they do some sort of financing to add liquidity. Basically, the thing is so thin, and market cap small right now, that if they ever hit in one of their indications, as the capital is structured now, the stock would go through the roof.
No, this is a "short attack" fueled by the "MM's" that are being paid by Merck's CEO who keeps shorting ARIA stock in an "effort to drive it lower" so he can "buy it on the cheap" but don't use stop limits because they're not "getting my shares for anything less than $65/ share or the poison pill."
There is plenty of ARIA stock to short legally. Please. This wasn't a case of naked shorting. ARIA sold off because people panicked when they read "black box". That and the fact that institutional ownership is over 80% and almost everyone has a cost basis of below 15; people can lock in low tax rate, and buy back. Look at whats going on in AAPL.
Ponatinib is best in class.
Somewhere, sometime, when people digest this "news" and stop being so reactionary about this label (for a drug that is best in class) there is going to be a great buying opportunity; heck, it might have even been yesterday. I'm gonna wait to see how it plays out.
But, I am not surprised about the selloff---almost every FDA approval has resulted in a "sell the news"; the black box label only accellerated it (ppl sold, without asking.....no one wants to be the last one out the door especially when institutional ownership is at 80%). Further, these same people have probably WANTED a reason to lock in their low long-term cap gains rates.....those same people can literally sell, lock in rate, and buy back immeidately (there is no wash sale rule on gains)...if they think its going up in the long term.
FWIW
Iclusig is being approved with a Boxed Warning alerting patients and health care professionals that the drug can cause blood clots and liver toxicity. The most common side effects reported during clinical trials include high blood pressure, rash, abdominal pain, fatigue, headache, dry skin, constipation, fever, joint pain, and nausea.
Ponatinib just got approved
Brand name: Iclusig
FYI
Yeah, it does seem "cheap" compared to much more expensive peers.
Their timelines are just so far off ; and thats unfortunate.
But if,by what Pucci seems to be saying, the CRC data is even good, and they have to run another Phase 2, what are we looking at? Another approved CRC drug in 2018? Or another poorly designed Phase 3 study like the NSCLC?
2-3 years is a long ways off; why bother getting "in" in a quick manner?
Their CEO is terrible (sidenote)
Hysterical.
I couldnt have said it any better myself.
Thanks.
I recall you being a valuable contributor re ONTY last year (i think on YMB or I Village).
Do you think the fact it passed two futilities as more favorable for the conclusion?
Also, its set up to have a 6 MONTH OS. Would this trial have a positive outcome if they showed, say, 4 months, with a good HR?
Gonna be a white knuckler for sure.
Looks like a couple other PD-1s have entered the clinic recently (besides Merck and BMS).
GSK, and I believe, Genentech have early stage trials going on in PD-1 now.
Too bad there are no small caps with a PD-1 :)
LOL no kidding.
Best not to put timelines on it like many other clown CEOs who two years after stating stuff about term sheets etc still havent delivered.
I spoke with the CFO last week; my vibe is they are nowhere near a partner. Got the old, "they want to see more mature data and/or see how the FDA meetings go"
If they can do a small single arm pivotal study for 011, I would prefer they go it without a partner because all a partner would bring to the table is money, and would most likely delay the trial for 6 months or more. If they need to do a large scale 800 person trial, they will NEED to partner because these guys would screw it up on their own. Either way, theyre gonna be raising more capital in 2013 I can guarantee you that.
BTW, did CEO say if they have dose any patients in 1135 yet?
CLDX
I'd rather buy EXEL at 1 bill MC than ARRY at 0.4 bill MC
Yes, I assume the site in Iowa.
Only info on 1135 and DDD was from your link as well as this:
http://www.healthcare.uiowa.edu/kidneeds/kidneeds%20fundrasing.htm
My guess is most kids will be going to Iowa. It is a small trial? 5 kids (or adults) if i can remember correctly? I suppose we could have another SRPT situation on our hands if some of these kids go public ;)
If they can't give accurate guidance that further into future, then don't give guidance. It IS credibility issue.
Has thiis CDX1135 study begun yet? I know it was supposed to begin this quarter but I see no mention of it on clinical trials . gov
ARRY
RE: the "CR" in 520. Is this a "complete response" or is this a "confirmed response" ( because this is a hemotology , as opposed to solid tumor).
Exactly. I can look at an image of a tumor and see that it has clearly regressed. You cant do this with CYTK so there is no "buzz" and, I dont know, and I dont think 99% of the investing public know, if the numbers that CYTK reports are even meaningful in the real world----
In real-life, are these results meaningful at all?
I think this is a big problem when trying to look at CYTK data (for non-PhDs or scientists); the average investor really has no clue if their data is good/bad/neutral. Myself, I really have no idea when I review their data for the most part - it's not very "real world" relevant when you look at their PRs and read these numbers - its not like an average investor, or even a money manager who's a generalist, can get excited about CYTK saying their results are positive.
Just saw this, thanks.
Doesn't really seem like anyone thinks it has a shot - as the Street is valuing it at zero.
Yup, as evidenced by the "no one cares about this" in the after-hours.
XOMA ANNOUNCES PERINDOPRIL AND AMLODIPINE FIXED-DOSE COMBINATION MEETS PRIMARY ENDPOINT IN PHASE 3 PATH TRIAL
Do you know much about XOMA, or like them?
Have a small position (long)
My personal opinion is, I don't think there is another mid-cap oncology company out there better positioned than Ariad right now.
About the market-cap? I have no idea - that's more of a function of risk-appetite for the whole sector.
Even more, LOL.
(where did i call anyone a "loser")
BTW, Don is right.
There is a place to discuss politics, taxes, and other garbage.....it is called the Yahoo Message Board.
There are about 3-4 top notch quality posters here with relevant medical information re ARIAD and its peripherals. The rest is noise and the good stuff tends to get washed out by all that noise.
FWIW
So how is everyone feeling going into the close of the trial?
They so seem quite confident. Directors buying, and CEO saying no way to issuing stock ahead of data.
CLSN - i have no position.