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2da -- Have you up-dated your 2014-15 event calendar?
Greggors -- Thanks.
I did forget that and it could certainly shorten the time frame.
If somebody robs your house, the police do the work and spend the money to get justice.
If the SEC and/or JD want to step in that would be great.
Its too big and too risky for Ariad. Millions of dollars and endless man-hours will be spent and it would take years. And after all that you still have these risks:
*Your lawyers aren't as good as their lawyers.(recall loss in NF-kB patent suit years ago.. Ariad never made that expense public)
*Burden of proof.
*Crazy and/or corrupt judges.
*Unpredictable juries.
I share your anger. But, sometimes you have to make choices.
Ariad should do what it is best at.. producing drugs that save lives.
No, not an admission of error. That is because every FDA behavior, no matter how bizarre, can be justified under the label -- "patient safety".
Perhaps the FDA label has to be narrowed.
The spin.
http://www.bostonglobe.com/business/2013/12/21/ariad-pharmaceuticals-gets-approval-restart-sales-leukemia-drug/15cDhDVFWd0q5EtqsV00HI/story.html
"FDA spokeswoman Stephanie Yao said patient safety is the agency’s top priority so regulators couldn’t permit Iclusig to remain on sale under its original label after increased safety risks were found."
Of course they could have proceeded as in Europe.. tightened the label without ever taking it off the market. FDA never likes to admit errors, but the speed of this reversal shouts "mistake".
So a lot of innocent investors lost fortunes; many at Ariad lost their jobs; cancer patients' anxiety was raised... but, thank goodness FDA put patent safety first. Where are all the vulture-like law firms trying to organize these victims. Oh, I guess that would involve real work.
Revenge !!
Harvey's revenge will not be a lawsuit vs. the obvious miscreants.
His revenge will be a new clinical trial that seeks to establish Iclusig as front line.
A lawsuit would take 5-10 years (including appeals etc.) and tie up huge amounts of cash and energy in unproductive areas (lawyers, discovery etc). A clinical trial with lower dose plus statin/aspirin only 2-3 years and would put Ariad's money to work in its most productive area.
Additionally, Ariad will need a friendly FDA going forward for its pipeline.
Frontline Iclusig would generate $3-5 billion/year (not to mention other applications like Gist etc.) and would sink the Novartis drug, Gleevec.
Success is the best revenge.
"Today is options expiration,so the mm and hedges will push aria under $4 at the close"
Good call !!
If the conjecture is based on the Sierra report, I give it zero weight.
An FDA precedent today:
After nearly destroying the diabetes drug Avandia by deciding that it posed an unacceptable risk of heart attack and stroke, OOOPS...
Today, the FDA admitted, well, it really doesn't. Of course, plenty of damage has been done.
http://www.reuters.com/article/2013/11/25/us-glaxosmithkline-fda-diabetes-idUSBRE9AO0VU20131125
I nominate Dr. Pazdur for the role of Scrooge this season.
Is there anything meaner than denying a life-saving drug?
" not derogatory, but a jab at the FDA"
Rum, I agree. HB is a fighter, pugnacious and abrasive by nature. I'd guess he would rather have thrown a knock-out punch (lawsuit) rather than a jab at the FDA and perhaps Novartis and others.
But, he's also a businessman. He knows he needs to cajole the FDA into re-thinking their decision and, for political reasons, not appear to be forcing them. Its not just Iclusig, he will need a cooperative FDA for 113 and the always-on-the-horizon new molecule.
I retain confidence in HB. He is in a pool with some big sharks. He can take a punch. In the end I believe he has built a wonderful lab, understands the science, and has the best interest of patients and shareholders in mind.
Of course I am kidding. Its called sarcasm.
When the FDA made its statement pulling Iclusig, did they end the statement with the word... "period."
If so, perhaps an apology is coming.
Will desperate US patients be traveling to Europe for treatments?
I think the FDA would want to avoid that outcome.
Will this European model provide a template for FDA to put Iclusig back on the US market?
"....and designation of our next clinical development candidate."
Maybe they can designate, but develop? Fuggedabotit !
Without a partnership (for one of their drugs) they can't do much and I doubt they can raise much selling stock.
I don't expect much drama tomorrow.
No announcements about buyout, partnership, suits vs. FDA or Novartis etc.
I do expect the outline of a plan for financial survival. Perhaps some hints about the pipeline.
JMO -- If something impactful were imminent, we would be up a few dollars today.
To quote from Casablanca..
“I’m shocked, shocked to find that gambling is going on here!”
How could you accuse Novartis of unethical behavior?
http://www.corp-research.org/novartis
2da -- If Gregorio's surmise is correct... just my opinion -- someone at the FDA is guilty of criminal negligence.
Think of the patients whose lives are in jeopardy.
"My concern is that the small stockholders are easily crushed in this battle"
2da ---- The way to think about small investors (like you and I) is that we are like the Remora fish which attaches itself to a shark. We go along for the ride and hope there are enough tidbits left over from the shark's work to fill our little bank accounts.
Sarissa appears to be competent both in the scientific issues and the financial issues.
Finally, a possible counter-weight to GS. If they get a board seat(s)and are allied with HB, this could get interesting.
This is the wondrous source:
http://sierraworldequityreview.blogspot.com/2013/10/ariad-pharmaceuticals-aria-rises-over-9.html
I have seen this outfit -- Sierra World Equity -- on other boards. Always a complete joke.
Yes, now that Cramer's short group is through knocking the price down to panic levels, they can start building it up to squeeze yet more long profits (and maybe set up a buyout for one of their BP clients)..
Apologies.. just in full conspiracy mode at the moment.
" ARIAD Pharmaceuticals, Inc. (ARIA) today announced that it will report its third quarter 2013 financial results on Wednesday, November 6, 2013, before the market opens. Following the announcement, at 8:30 a.m. Eastern Time, company management will host a conference call and webcast discussion of the results and provide a general corporate update."
"and provide a general corporate update."
Gotta love the boilerplate.
There was such huge short volume on the way down. Perhaps we are seeing the start of a huge covering volume.
With the caveat that pre-market usually is meaningless, it may be worth noting that Ariad is up almost 5.69% with 318000 shares trading.
I have no clue, but perhaps the bottom has been passed.
There is so much fear, shock, panic and confusion as a result of this gigantic loss of value. Nobody seems to know what might be a possible or best way forward.
Perhaps Dr. Berger should consider an open letter to the shareholders discussing how management sees the current situation scientifically and financially; how they plan to raise money if needed; attitude now toward partnership/buyout etc.
Shareholders need guidance, imo.
Almost all drugs are dirty in that they have side affects. Aspirin can have side affects... bleeding etc.
Just listen to the warnings for the drug ads on tv and you are amazed that anyone ever uses those products.
Every one of Ariad's competitor products has side affects. The "dirty drug" label attached to Ariad is strictly the product of internet commentators who have their own agenda. IMO that label is directed toward stock buyers and sellers. Oncologists are more sophisticated.
I believe that a new molecule has been ready for over a year.
For all the various reasons mentioned, they have practiced abstinence...
timing of news on current pipeline
not tipping their mitt to opponents
lack of manpower and financing to move forward
To that let me add another. I suspect that their experience in bringing Iclusig and 113 to market has prompted Ariad to develop and tweak the new molecule in a way to avoid certain hazards they met with the current drugs.
I fully expect the next molecule to have blockbuster potential.
NVS has an enormous footprint in Cambridge.
http://www.wikinvest.com/stock/Novartis_AG_%28NVS%29/Nibr_Headquarters_Building_Cambridge
Right now Ariad is right adjacent to it. The new Ariad HQ will be some distance (relatively speaking) from this location but of course still in "walking distance". I'd guess about one mile.
yes, and that tumor lysis suggestion I believe was made by Mike King -- the best analyst out there.
2da -- Do you think the market on Monday will focus on "great potential" or on the pulmonary events?
Ariad is playing defense on the call... almost all questions relate to the pulmonary events. (It seems not to matter that this was a dosing trial).
And, of course, the trial delay ("a little bit later this year" "very shortly") is a negative.
AF should have a ball on Monday. We shareholders, not so much.
" Looks like competitor on brain mets??"
Doug -- At the last annual meeting a major distinguishing point in the development of Ariad's drug was its effectiveness against brain mets. Competition would certainly be a downer.
Why is the run-up before ESMO a run-down?
Rum -- Since the beginning of the year Ariad has done much worse than the biotech index...
http://finance.yahoo.com/q/ta?s=IBB&t=1y&l=on&z=l&q=l&p=&a=&c=aria
As the user group expands, Ariad must be building a plentiful background of reliable cases to give increasing confidence both to the Ariad sales force and to oncologists who are on the fence.
Thanks Doug. Very encouraging.
------
There is an unmet need called GIST.
For which all drugs have badly missed.
Gleevec had helped some,
But Pona has now come,
And Novartis is certainly pi##ed.
$13.5 billion valuation for a company that had revenues of $500MM in 2012.