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6:00-8:00 pm: Clinical Impact Of Dose Modification On Response To Ponatinib In Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML)
https://ash.confex.com/ash/2013/webprogram/Paper56828.html
I am not sure whether this is the same poster. I cannot access your pdf file because it is blocked by my company:
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This Websense category is filtered: Prescribed Medications.
URL:
http://congressposters.ariad.com/downloads/packages/37/ASH2013_PACE_DoseMod_poster_FINAL.pdf
The creditability of BMO is great as Rachel McMinn's:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94511750
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94512178
Mt cluelessness is evidenced by my clueless post about FMR's Ariad holdings:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94760474
That poster is right. I am clueless.
It's patently silly trying to manipulate the pre-market to cause panic-selling by means of initiating the pre-pmarket trading with 20 shares at $3.64.
The lawyers should be suing the FDA instead.
These lawsuits never go anywhere?
I hope the law firm might help me get $0.001 per 1,000 shares that are qualified for the class action.
From: Biomaven
It's just weird when you compare the FDA analysis (and that of the French trial), with the frontline trial reported, which showed major molecular response (MMR) in 74% of patients, with the drug described as "well tolerated" and 7% hypertension being the only reported cardiovascular AE.
Peter -- http://www.siliconinvestor.com/readmsg.aspx?msgid=29270286
Even Biomaven find the delta weird.
"The different interpretation and calculation of rates of toxicity as reported by the manufacturer versus the FDA was concerning, given that everyone was looking at the same raw data. This is an example of the need for common parameters for calculating such risks," said Michael J. Mauro, MD, Leader of the Myeloproliferative Diseases Program at Memorial Sloan-Kettering Cancer Center who was an investigator on both the drug’s Phase I and II trials. “One can render different opinions on their impact and their weight, but there shouldn’t be different ways of interpreting the risks or different ways of categorizing them.”
http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=902
"ARIA reminds my of BIIB with Tysabri and PML appeared
BIIB went to $30 and everyone said Tysabri is dead" will be pulled from market. Well, Tysabri did fine because it was the only thing that worked in very severe MS patients. ARIA drug same thing. FDA will keep it on market because there is nothing else. Plus, cancer docs aren't afraid of some blood clots when their patients have no other drug for their stage of disease. This is why FDA didn't pull it. This drug will do fine.", posted aw00108400 on the YMB.
FMR increased ARIA holdings to 27,392,509 shares from 17,289,316 shares. 13G filling date: November 8, 2013.
http://services.corporate-ir.net/SEC.Enhanced/SecCapsule.aspx?c=118422&fid=9096378
I am not sure whether it was Fidelity's end of 3rd quarter filing or Fidelity added 10 million shares after the flash crash. If it is the former, then fidelity is the largest loser on Ariad. However, Fidelity plays with money using other people's money. If it is the latter, it seems to be good news for ARIA shareholders.
Early 2000, Fidelity was the No. 1 institutional holder with 1 million shares. Fidelity sold all of 1 million shares after ARIA started to drop from $48.50 early March, 2000. Fidelity had been keeping on the sideline until the 1st quarter of 2010 when it bought 15 million ARIA shares. Fidelity has been the No. 1 institutional holder of ARA since then.
Owner Name: FMR LLC
Date:09/30/2013
Shared Held: 19,590,830
Change (Shares): +2,301,514
Change(%): 13.31
http://www.nasdaq.com/symbol/aria/institutional-holdings
g_of_j: "I hope the law firm might help me get $0.001 per 1,000 shares that are qualified for the class action."
zipjet: "That is a bit low. You might get ten times that.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94759638
FMR continues to buy and hold ARIA after the big plunge, which indicates the largest mutual fund is very confident on Ariad, at least it seems to me.
...This may explain why certain funds, like Sarissa, have been accumulating the stock after the big plunge.
I agree and Grandma has been hammering home this same valid point.
Monday evening's presentations, in conjunction with Ariad's own clinicians, are expected to be most positive for the company from an investment point of view as well.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94747128
How can you extrapolate on a total population from such a small sample and not reviewing correlations with other preexisting conditions of SAE.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94746322
It's very old news clarified a long time ago, based upon which, the Oppenheimer paid basher and the shorts are ridiculously bashing Ariad:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=93825265
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94128394
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94738766
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94745692
zipjet is not only a lawyer, but also an outstanding statistician.
The smaller the effect being measured, the bigger the study or N necessary to prove it.
The bigger the effect, the smaller the N.
You could prove that 30 grams of arsenic will kill a person with a very small N - of course you will not get volunteers.
I hope the law firm might help me get $0.001 per 1,000 shares that are qualified for the class action.
As much as 10 cents per 10,000 shares? That's a huge amount of money! I will definitely find a good law firm and join a class lawsuit against Ariad.
Disclosure: I was an old timer Ariad believer although I have a short position now.
The different interpretation and calculation of rates of toxicity as reported by the manufacturer versus the FDA was concerning, given that everyone was looking at the same raw data. This is an example of the need for common parameters for calculating such risks, said Michael J. Mauro, MD, Leader of the Myeloproliferative Diseases Program at Memorial Sloan-Kettering Cancer Center who was an investigator on both the drug’s Phase I and II trials. “One can render different opinions on their impact and their weight, but there shouldn’t be different ways of interpreting the risks or different ways of categorizing them. That’s a lesson this experience has taught us.”
http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=902
Video: More on Ponatinib and Next Steps - Harry Erba, MD.
Published on Nov 7, 2013
Harry Erba, MD, Director of the Hematological Malignancies Program at the University of Alabama at Birmingham shares more insights into the latest news on Iclusig (Ponatinib) and important information for the days ahead. He shares some background information on the drug's efficacy in CML treatment and discusses the process of submitting the individual Investigational New Drug (IND) application that will be required to access the drug.
Please delete this..
Video: More on Ponatinib and Next Steps - Harry Erba, MD.
Published on Nov 7, 2013
Harry Erba, MD, Director of the Hematological Malignancies Program at the University of Alabama at Birmingham shares more insights into the latest news on Iclusig (Ponatinib) and important information for the days ahead. He shares some background information on the drug's efficacy in CML treatment and discusses the process of submitting the individual Investigational New Drug (IND) application that will be required to access the drug.
The French study is obviously biased as stated by the French investigators themselves:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94745692
Though biased, the French study is very good and the following conclusion should be very helpful:
These results should promote an extreme vigilance especially in older pts with known CV risk factors that will need to be strictly controlled and monitored. A preventive anti-thrombotic prophylaxis might be useful since Ponatinib initiation.
I hope the law firm might help me get $0.001 per 1,000 shares that are qualified for the class action.
That is a bit low.
You might get ten times that.
smile
Class action security lawsuits are the REAL FRAUD.
zip - BTW - I am a lawyer.
Despite the small size and the relative heterogeneity of this Ponatinib cohort, the obvious caveats and bias of such a study, despite high efficacy rates, Ponatinib induces significant high CV events in CP CML pts, after a relatively short period of exposure to this compound as compared to a historical cohort of Nilotinib-treated pts. The role of prior Nilotinib exposure remains to be determined. These results should promote an extreme vigilance especially in older pts with known CV risk factors that will need to be strictly controlled and monitored. A preventive anti-thrombotic prophylaxis might be useful since Ponatinib initiation.
https://ash.confex.com/ash/2013/webprogram/Paper59574.html
The FDA found increased SAE rates (48% and 24% in PACE Phase I and II).
Elevated SAEs also found by other investigators: A study from French investigators (Nicolini et al., 2013 ASH meeting abstract #4020) found that in a cohort of 19 CML patients on Iclusig, 42% experienced CV events after a median of 8.5 months on drug, strikingly worse than a historical cohort of nilotinib-treated patients.
Source: Oppenheimer/Ferreiro, December 6, 2013
Nice Post! Tom Silver, an Ariad long before the flash crash and an Ariad short after the crash, posted the same at almost the same time.
Tom Silver ?@TomSilver39 2h
$ARIA Debating the FDA Decision to Suspend Marketing and Sales of the Leukemia Drug Ponatinib (Iclusig) http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=902
"To boost their claim, the FDA listed in a press release the events of some rather unfortunate side effects to illustrate their point, ignoring that the very ill patients had other conditions besides CML, notably diabetes, that could very well have been the leading cause of those SAEs. In some cases, the FDA points out at least two patients in their 20's who experienced FDA-defined SAE's, ignoring to state in their press release these patients were in the end state, or blast phase of the disease, with no alternative treatment than Iclusig. The drug saved one, the other sadly did not respond to treatment. Few of these very ill patients actually die from a SAE while the hundreds and hundreds of patients are alive today because of Iclusig.
Immediately after asking (forcing) Ariad to stop selling the drug, the FDA told existing patients that they could apply through the FDA so that Ariad would provide the drug for free. And that is on-going. Nothing has changed, except that this upstart biotech, Ariad, is slowing going out of business by keeping these desperate patients, who were paying for the drug, alive with free drug.", 2damoon1 wrote.
"To boost their claim, the FDA listed in a press release the events of some rather unfortunate side effects to illustrate their point, ignoring that the very ill patients had other conditions besides CML, notably diabetes, that could very well have been the leading cause of those SAEs. In some cases, the FDA points out at least two patients in their 20's who experienced FDA-defined SAE's, ignoring to state in their press release these patients were in the end state, or blast phase of the disease, with no alternative treatment than Iclusig. The drug saved one, the other sadly did not respond to treatment. Few of these very ill patients actually die from a SAE while the hundreds and hundreds of patients are alive today because of Iclusig.
Immediately after asking (forcing) Ariad to stop selling the drug, the FDA told existing patients that they could apply through the FDA so that Ariad would provide the drug for free. And that is on-going. Nothing has changed, except that this upstart biotech, Ariad, is slowing going out of business by keeping these desperate patients, who were paying for the drug, alive with free drug.", 2damoon1 wrote.
They must've changed the SAE definition intentionally. The FDA officials are not idiots, are they?
The researchers had since submitted findings from the PACE trial for publication in the New England Journal of Medicine, which were published on November 7 (2013;369:1783-1796). That paper noted that with an additional 13 months of exposure, in patients who continued in the trial, the cumulative incidence of serious arterial thrombotic events was 11.8 percent and the incidence of all arterial thrombotic events—serious or not—was 17.1 percent.
...
The EMA said their review of the data had found the rate of serious occlusive vascular events to be 22 percent for the Phase I trial and 13.8 percent for the Phase II trial, as of September 2013—both of which were much lower than what the FDA had reported.
Michael J. Mauro, MD, Leader of the Myeloproliferative Diseases Program at Memorial Sloan-Kettering Cancer Center who was an investigator on both the drug’s Phase I and II trials, said that the different interpretation and calculation of rates of toxicity as reported by the manufacturer versus the FDA was concerning, given that everyone was looking at the same raw data. This is an example of the need for common parameters for calculating such risks, he said. “One can render different opinions on their impact and their weight, but there shouldn’t be different ways of interpreting the risks or different ways of categorizing them. That’s a lesson this experience has taught us.”
http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=902
"Ponatinib was pulled by the FDA under VERY suspicious circumstances. They changed the definition of what constitutes an adverse event, then attributed every event to the drug, despite the fact that these patients were heavily pretreated and in BLAST phase. They came to the study at deaths door after failing all other options."
http://news.yahoo.com/fda-cancer-czar-floats-change-drug-review-process-120000099.html
"You went through a lot of the differences in how the thrombotic events are counted. I guess, why was the change in the FDA methodology? Where did that come from?", asked Michael J. Yee, RBC Capital Markets.
"I think that's not anything that we can comment on or know. So we're just not really in a position to comment on that.", answered Timothy P. Clackson.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=93998347
Tom Silver:
$ARIA Oppenheimer: Further Changes to Label or a Recall are Still Possible, Elevated SAEs also found by other investigators:
Tom Silver:
$ARIA 42% experienced CV events after a median of 8.5 months on drug,strikingly worse than a historical cohort of nilotinib-treated patients.
Tom Silver:
$ARIA A study from French investigators (Nicolini et al2013 ASH meeting abstract 4020) found that in a cohort of 19 CML patients on Iclusig.
Pancreatitis was the most common drug-related serious AE (5%); it occurred early and was primarily managed with dose modification, 1 pt discontinued. Serious cardiovascular, cerebrovascular, and peripheral vascular AEs occurred in 6%, 3%, and 2% of pts (drug-related: 2%, 1%, 1%).
Ponatinib is effective as initial therapy for CML-CP resulting in high rates of cytogenetic and molecular responses at early timepoints. Therapy with ponatinib is well tolerated with transient elevated lipase being the most common toxicity. In view of the frequency of dose reductions and considering the excellent responses achieved, the trial has been modified to explore 30 mg as initial dose.
The Oppenheimer analyst doesn't know statistics if he/she is not a paid Ariad basher. In principle of statistics, a small data sample is not sufficient to make a meaningful conclusion.
I posted on 11/16/2013:
According to the 55th ASH presentations, Ponatinib is well tolerated and Adverse Events are manageable.
There is exception, the French presentation. But the authors of that presentation admit that the number of their sample patients is small (only 19 patients). In principle of statistics, a small amount of data is not enough to make a meaningful conclusion.
Transient elevated lipase rather than blood clot is the most common toxicity. Unacceptable? Should I believe biomaven, the FDA or Dr. Cortes? I am confused.
"Ponatinib is effective as initial therapy for CML-CP resulting in high rates of cytogenetic and molecular responses at early timepoints. Therapy with ponatinib is well tolerated with transient elevated lipase being the most common toxicity. In view of the frequency of dose reductions and considering the excellent responses achieved, the trial has been modified to explore 30 mg as initial dose."
https://ash.confex.com/ash/2013/webprogram/Paper64338.html
The Agency will now carry out this review to assess the need for further changes to how the medicine is used.
Ariad may partner Iclusig. The big pharm companies know the huge $ potential of Iclusig. The CML patients need the life-saving drug.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94671488
"We don't rule out the front line. But it would have to be based upon data, not just hypothesis. It really depends on the dose and the data we collect in the front line. Clearly, we need to run trials at lower doses," said Ariad CEO Harvey Berger.
That's why I want to short it, too. I want to join a lawsuit, too. I hope the law firm might help me get $0.001 per 1,000 shares that are qualified for the class action.
To stop grandma, you must continue your efforts. I won't stop posting unless I am banned again.
The best way to stop me is to continue your off-topic personal attacks so that I will continue to fight back with my off-topic counterattacks which might violate the rules of the board.
I strike back against any personal attacks even though I may be banned again from posting on this board.
I never initiate any attacks on anybody although I do strike back.
How is your Gloria doing? How is Bloria_Researcher doing?
As long as ARIAD can clearly demonstrate the fact that they only referred to clinical data made known to they and their information base without any INTENT to defraud the law firms can suck eggs and pound sand bags. Lawsuits are very common, winning is something else again. ARIAD has a number of defense/cross action options certainly well known by their legal dept.
And we hold this position based on almost 500 years of collective legal/investment experience.
It will probably take until May before we have an answer.
Are all the Serious Adverse Events drug-related?
It seems that the clinical trial doctors differentiate the Iclusig-related SAE's from the ones that are not Iclusig-related while the FDA counts all the AE's as Iclusig-related SAE's, which is probably the root cause of the enormous gulf between the 2 heart SAE rates (the doctors' 4% vs. the FDA's 24%).
Hopefully, the Europeans are as intelligent as the doctors, differentiating the type of AEs (Iclusig-Related or not; Serious or Not).
The EMA review is about how to use Iclusg wisely. A full data review will probably conclude that the drug is well tolerated and the SAE rate is not too high.
Unlike the FDA, the EMA is doing the right thing.
... the European Commission considered that a further in-depth review of relevant data was necessary.
The Agency will now carry out this review to assess the need for further changes to how the medicine is used.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Iclusig/human_referral_prac_000033.jsp&mid=WC0b01ac05805c516f
This (the review) should include a full assessment of the nature, severity and frequency of these events, and appropriate classification (with justification) of these events by seriousness (ie. serious or non-serious) in line with ICH definitions.
The EMA is doing the right thing.
"We have to see what the data holds," Dr. Pazdur said.
"It would have to be based upon data, not just hypothesis," Dr. Berger said.
Pancreatitis was the most common drug-related serious AE (5%); it occurred early and was primarily managed with dose modification, 1 pt discontinued. Serious cardiovascular, cerebrovascular, and peripheral vascular AEs occurred in 6%, 3%, and 2% of pts (drug-related: 2%, 1%, 1%).
Ponatinib is effective as initial therapy for CML-CP resulting in high rates of cytogenetic and molecular responses at early timepoints. Therapy with ponatinib is well tolerated with transient elevated lipase being the most common toxicity. In view of the frequency of dose reductions and considering the excellent responses achieved, the trial has been modified to explore 30 mg as initial dose.
"We don't rule out the front line. But it would have to be based upon data, not just hypothesis. It really depends on the dose and the data we collect in the front line. Clearly, we need to run trials at lower doses," said Ariad CEO Harvey Berger.
The next Amgen? I don't think it will be the next Amgen anytime soon.
I am long - very long: But my guess is that owning ARIA should be viewed as a two year hold to get resolution of the problems and significant recovery in the stock price from here.
Jesspro, that Iclusig future prediction is not bad given it was posted at 5:00 am on Nov. 12.
Hours later, Dr. Berger said "We don't not rule out the front line" at the 3Q CC and he said another medication preventing clots may be as simple as an Aspirin.
"It really depends on the dose and the data we collect in the front line. Clearly, we need to run trials at lower doses. We don't rule out the front line. But it would have to be based upon data, not just hypothesis."
Grandma, that's a nice letter and I hope that she can initiate an investigation. That's all we want. We want to find out if the FDA is wrong and the doctors are right or vice versa.
http://investorshub.advfn.com/boards/replies.aspx?msg=94160853
Will an EPIC-like trial with low doses + a statin/Aspirin be restarted?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94040906
Dr. Harvey Berger's goal is still to bring Iclusig to the front line. He said:
"It really depends on the dose and the data we collect in the front line. Clearly, we need to run trials at lower doses. We don't rule out the front line. But it would have to be based upon data, not just hypothesis."
"Ponatinib is effective as initial therapy for CML-CP resulting in high rates of cytogenetic and molecular responses at early timepoints. Therapy with ponatinib is well tolerated with transient elevated lipase being the most common toxicity. In view of the frequency of dose reductions and considering the excellent responses achieved, the trial has been modified to explore 30 mg as initial dose."
https://ash.confex.com/ash/2013/webprogram/Paper64338.html
Historically, ARIA almost reached $50. Do you know the actual historical fact?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94631974