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Thanks, Jesspro. The truth behind the enormous gulf between the 2 SAE rates should be made public by both Ariad and the FDA, which is why I also hope senators Elizabeth Warren and Edward Markey can initiate an investigation as you do.
You wrote:
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
To DewDiligence, vidpok45 and mejs:
Thank you very much for your kind comments on my patently silly belief: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94160853" rel="nofollow" target="_blank" >http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94160853"[tag]Doctors know more about Iclusig than the FDA.[/tag]"
The clinical trial doctors have treated and examined the patients physically. Don't they know about the safety/toxicity of Iclusig more than anybody else?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94200275
I even have sillily contacted senators Edward Markey and Elizabeth Warren , telling them about my patently silly belief that doctors know more about Iclusig than the FDA.
A large number of doctors have concluded that "Ponatinib is well tolerated and Adverse Events are manageable." They are a great deal more than any individual doctor, no matter how renowned or how malicious to Ariad any individual may be.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94160853
Dew, do you agree with mejs and vidpok45? Please click here for mejs' comments and here for vidpok45's comments.
Patently silly or not, I firmly believe Doctors know more about Iclusig than the FDA, for a large number of doctors conclude that "Ponatinib is well tolerated and Adverse Events are manageable". They are a great deal more than any individual doctor, no matter how renowned or how malicious to Ariad the individual may be.
I even have contacted Senator Edward Markey and Elizabeth Warren , telling them about my patently silly belief that doctors know more about Iclusig than the FDA.
Did you count how many doctors will be present at the 55th ASH before you commented "That’s patently silly" on my patently silly belief? Did you count how many doctors have contributed to the NEJM paper titled "A Phase 2 Trial of Ponatinib in Philadelphia Chromosome–Positive Leukemias"?
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To vidpok45 and mejs:
Thank you very much for your comments on my patently silly belief: doctors know more about Iclusig than the FDA.
The clinical trial doctors treat and examine the patients physically. Don't they know about the safety/toxicity of Iclusig more than anybody else?
To Sen. Warren: Doctors treat the patients physically. They know about the safety/toxicity of Iclusig more than anybody else.
Sillily believing Doctors know more about Iclusig than the FDAI wrote to Senator Elizabeth Warren the following (my thanks to 2damoon1 for his help):
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Please inquire into an evolving situation regarding Ariad Pharmaceuticals, a Biotech company based in Cambridge, MA, and the FDA.
Recently, the FDA reviewed its accelerated approval of Ariad's life-saving drug named Iclusig and forced Ariad to ‘voluntarily’ withdraw it from the market.
Doctors and patients across the country obviously disagree with the FDA as 23 leukemia specialists and 3 patient advocacy groups sent the FDA a letter saying they were concerned right after the FDA withdrew the life-saving drug Iclusig according to an article titled "Doctors Fear Losing Leukemia Drug Deemed Risky" published on The New York Time, November 1, 2013. The link to the article is provided at the end of this message.
Virtually every leading physician in the CML field has written the FDA in support of Ariad, and countless patients have also. There is an enormous gulf between these doctors' view of SAE's vs. the FDA's views, in one case 4% SAE's for the doctors, 24% for the FDA. Other disparities are even greater. How can the disparities be so great?
Don't the doctors who conduct the clinical trials of Iclusig and treat the patients physically know about the safety/toxicity more than anybody else? They believe Ponatinib (Iclusig ) is well tolerated and Adverse Events are manageable as evidenced by their presentations at the coming 55th ASH, Dec. 7 - 10, 2013. (A link is also provided at the end of this message).
The leukemia specialists believe "Ponatinib is a good drug. We don’t want it to be killed and not given to patients." Don't the doctors know more and better about Iclusig than the FDA?
“Without this medication, they won’t have long to live. My patients are panicked. I have patients right now who are benefiting from this medication with very few side effects.” said Dr. Brian Druker, the director of the Knight Cancer Institute at Oregon Health and Science University.
“What we don’t want to have happen is for a good drug, ponatinib, to be killed and not given to patients,” said Dr. Javid Moslehi, a co-director of the cardio-oncology program at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston.
The doctors will tell more truth about the Efficacy and Safety of Iclusig at the 55th ASH, December 7-10, 2013. They believe Ponatinib is well tolerated and Adverse Events are manageable.
Dr. Javid Moslehi said in an interview that if, for instance, the problems were known to occur because of excessive blood clotting from a cancer drug, then patients could also be given another medication to prevent clots. Or, if the cancer drug were causing plaque to build up in the arteries, patients might be given a statin to try to prevent it.
“What we don’t want to have happen is for a good drug, ponatinib, to be killed and not given to patients,” Dr. Moslehi said.
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The problem with the FDA’s position is two-fold. Statistically, over time, the number of SAE’s actually drops, meaning that the longer the patient population stays on the drug, the rate of SAE’s actually drops somewhat. Secondly, the FDA changed the definition of SAE’s to include virtually any side effect, serious or not, and attributes them to the treatment. This definition change has literally doubled (and more) the FDA’s SAE count from when the drug has been approved.
Keep in mind, this drug's registration trial was on the sickest of the sick patients with CML, patients who had failed all other drugs and treatments. Most were older, with many other afflictions, and physically damaged having gone through years of other similar medications to which they had become refractory.
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.
Nonetheless, doctors and Ariad have designed dose limiting strategies for this powerful drug, Iclusig, techniques that are fairly common with cancer drugs to address the FDA’s concerns, and is reworking its label to limit SAE prone patients access to the drug. Still, time is running out for new patients now blocked from the drug.
Compounding this, much damage has already been done to Ariad. Ariad is in deep financial danger. Last week, to survive, the company laid off 40% of its Cambridge, MA staff, that is 200 scientists and other workers. Promising trials of the drug in other very nasty cancers, notably GIST, remain closed to new patients. Those shut out will suffer or die on some inferior treatment.
Please look into this. I ask that you speak to Ariad management, get their side of the matter. Then, likewise, to the FDA team. Something just isn’t right. Consider if the FDA is overreacting here. Permit Ariad to immediately resume selling the drug to those for whom life would end without it.
I am saddened to see the tortuous and unnecessary destruction of this company, and the end to its groundbreaking treatments. The FDA’s actions are antipodal to their mandate, and to government itself. Instead of helping and protecting patients, it is hurting, in some cases certainly, killing off desperate patients who are not permitted to start on the drug now. Patients dying, jobs lost, FDA dragging its heels. It’s not the way government was meant to be. I know you care about good government oversight. Please help.
Ariad’s phone (617) 494-0400. The CEO's email address is harvey.berger@ariad.com.
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P.S:
Link to the New York Time article "Doctors Fear Losing Leukemia Drug Deemed Risky":
http://www.nytimes.com/2013/11/02/health/doctors-fear-losing-leukemia-drug-deemed-risky.html?pagewanted=1&_r=3&partner=rssnyt&emc=rss&adxnnlx=1384675370-qFR2pICcxyo2PSRUr7j9Pw
55 ASH presentations are related to Iclusig's Efficacy and Safety:
https://ash.confex.com/ash/2013/webprogram/start.html#srch=words%7CPonatinib%7Cmethod%7Cand%7Cpge%7C6%7CbyDayany%7Cany%7CbySymposiumany%7Cany
Individual doctor? Much more than an individual doctor! The ASH presenters are more than any individual doctor and more than a individual presentation will conclude that Ponatinib is well tolerated and Adverse Events are manageable.
25 doctors from many countries did the 2-Year FACE Trial Follow-Up. Their conclusion is "Serious cardiovascular, cerebrovascular, and peripheral vascular AEs occurred in 6%, 3%, and 2% of pts (drug-related: 2%, 1%, 1%)."
As a finding of EPIC study, 11 doctors from MD Anderson conclude that 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.
Doctors know more about Iclusig than the FDA, I believe.
I strongly disbelieve the FDA is involved in any conspiracy. What about the doctors? What about the individual doctor(s) Elliot Favus? surveyed? What about those who hate Ariad?
To the author of the 2 following posts: Did you count how many doctors will be present at the 55th ASH?
Quote:Doctors know more about Iclusig than the FDA.
That’s patently silly.
FDA simply has more data at its disposal than any individual doctor, no matter how renowned. Thus, the assertion in a prior post, “Doctors know more about Iclusig than the FDA,” isn’t true.
Doctors know more about Iclusig than the FDA. Those who conduct the clinical trials of Iclusig and treat the patients in person know about the safety/toxicity more than anybody else. They believe Ponatinib is well tolerated and Adverse Events are manageable.
The doctors obviously disagree with the FDA as 23 leukemia specialists and 3 patient advocacy groups sent the FDA a letter saying they were concerned right after the FDA withdrew the life-saving drug Iclusig.
******
Doctors: Ponatinib is a good drug. We don’t want it to be killed and not given to patients.
“Without this medication, they won’t have long to live. My patients are panicked. I have patients right now who are benefiting from this medication with very few side effects.” said Dr. Brian Druker, the director of the Knight Cancer Institute at Oregon Health and Science University.
“What we don’t want to have happen is for a good drug, ponatinib, to be killed and not given to patients,” said Dr. Javid Moslehi, a co-director of the cardio-oncology program at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston.
Source: Doctors Fear Losing Leukemia Drug Deemed Risky,The New York Time, November 1, 2013
The doctors will tell more truth about the Efficacy and Safety of Iclusig at the 55th ASH, December 7-10, 2013. They believe Ponatinib is well tolerated and Adverse Events are manageable.
Dr. Javid Moslehi said in an interview that if, for instance, the problems were known to occur because of excessive blood clotting from a cancer drug, then patients could also be given another medication to prevent clots. Or, if the cancer drug were causing plaque to build up in the arteries, patients might be given a statin to try to prevent it.
“What we don’t want to have happen is for a good drug, ponatinib, to be killed and not given to patients,” Dr. Moslehi said.
Doctors: Ponatinib is a good drug. We don’t want it to be killed and not given to patients.
“Without this medication, they won’t have long to live. My patients are panicked. I have patients right now who are benefiting from this medication with very few side effects.” said Dr. Brian Druker, the director of the Knight Cancer Institute at Oregon Health and Science University.
“What we don’t want to have happen is for a good drug, ponatinib, to be killed and not given to patients,” said Dr. Javid Moslehi, a co-director of the cardio-oncology program at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston.
Source: Doctors Fear Losing Leukemia Drug Deemed Risky,The New York Time, November 1, 2013
The doctors will tell more truth about the Efficacy and Safety of Iclusig at the 55th ASH, December 7-10, 2013. They believe Ponatinib is well tolerated and Adverse Events are manageable.
Dr. Javid Moslehi, a co-director of the cardio-oncology program at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston, said in an interview that if, for instance, the problems were known to occur because of excessive blood clotting from a cancer drug, then patients could also be given another medication to prevent clots. Or, if the cancer drug were causing plaque to build up in the arteries, patients might be given a statin to try to prevent it.
“What we don’t want to have happen is for a good drug, ponatinib, to be killed and not given to patients,” Dr. Moslehi said.
Obviously, the doctors disagree with the FDA as 23 leukemia specialists and 3 patient advocacy groups have sent the FDA a letter saying they were concerned on the FDA's withdrawal of Iclusig.
I believe the doctors who conduct the clinical trials of Iclusig and treat the patients in person know about the safety/toxicity more than anybody else. They believe Ponatinib is well tolerated and Adverse Events are manageable. They know more about Iclusig than the FDA.
The Boston Globe: Ariad fears that the FDA has "created a lot of confusion and questions” among doctors and patients.
The Boston Globe news, Nov. 13, 2013:
When one analyst questioned the wisdom of publicly taking issue with US regulators, Ariad chief scientific officer Timothy P. Clackson said, “We felt obligated to, in a very careful way, explain our understanding” of the clinical data because of fears the FDA “created a lot of confusion and questions” among doctors and patients.
“The FDA cannot provide a comment, as these issues are under review,” an agency spokeswoman said Tuesday. “It’s important to note though that this action was not only based on event rates, but also the seriousness of these rates, where significant harm to patients was identified.”
Some people think the FDA obviously hate Ariad for some reason. Analyst Jason Kantor at Crédit Suisse probably agrees with bocci911 as he asked Ariad at the 2013 3Q Earnings Call :
"I really appreciate all the information on the event rates for Iclusig, but there just seems to be a pattern where FDA says one thing and then you guys come on the call publicly and say something else. So I'm just wondering, what's the logic of having this debate in a public forum? It just seems like every time you guys do that, they come down hard on you at the next possible opportunity. So I'm just wondering why you think this should be prosecuted in public rather than just in meetings with FDA?"
Is it was reported by The Boston Globe on 11/13/2013 that Ariad was publicly taking issue with US regulators again.
If Jason Kantor's observation is right, the FDA will come down even harder on Ariad at the next possible opportunity.
How hard will the FDA come down on Ariad at the next possible opportunity? Anybody has a clue?
EPIC trial had problems? Dr. Cortes and other 10 doctors disagree as they are going to present what they believe on 12/07/2013 at the 55th ASH:
Ponatinib As Initial Therapy For Patients With Chronic Myeloid Leukemia In Chronic Phase (CML-CP)
https://ash.confex.com/ash/2013/webprogram/Paper64338.html
The 11 doctors' Conclusion is
"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."
2damoon1, do you have a version for Senator Elizabeth Warren? Thank you.
More likely, IMO, is that ARIA thinks the goodwill from free treatment can be leveraged somehow to get a better outcome from the FDA. In reality, the FDA probably isn't influenced by any of this, however.
Dr. Harvey Berger's goal is to bring Iclusig to the front line.
It was said that BIIB's Tysabri came back after 18 months, which might be the reason why Ariad's time frame for Iclusig to come back would be 18-20 months.
Dr. Berger is not in a hurry to bring it back to the market. However, once Iclusig comes back, it will go to the first line.
The analyst at BMO figured it out, saying "we continue to believe that a label for ICLUSIG in patients with T315i is most likely but ARIA does not seem inclined to pursue such a narrow indication."
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Y. Katherine Xu - William Blair & Company L.L.C., Research Division:
"Okay. And onto Iclusig, just one follow-up question. Do you think, with the profile you see so far -- maybe there are some differences in analyses between yours and the FDA's. But do you think Iclusig could go back anytime to the front line setting at all?"
Harvey J. Berger - Principal Founder, Chairman of the Board, Chief Executive Officer, President and Chairman of Executive Committee:
"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."
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Surely, it depends on data, not just hypothesis. Data speaks! Let's look at the clinical trial data:
ASH presentation Conclution (to be presented on 12/07/2013): "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."
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With such great data, why shouldn't Ponatinib go to the front line and the ultimate line (1st line and last line) to help the CML patients live a good life?
It's 2.6% vs. 24% if the treatment duration factor is taken into account.
The doctors' View (2-Year Follow-Up): "Serious cardiovascular, cerebrovascular, and peripheral vascular AEs occurred in 6%, 3%, and 2% of pts (drug-related: 2%, 1%, 1%)."
The FDA View (median treatment duration 1.3 years): "24% patients have experienced serious adverse vascular events."
There is an enormous gulf between these doctors' view of SAE's vs. the FDA's views, in one case 4% SAE's for the doctors, 24% for the FDA. Other disparities are even greater. How can the disparities be so great?
FDA: 24% patients (median treatment duration 1.3 years) have experienced serious adverse vascular events.
2-Year Follow-Up Of The PACE Trial: "Serious cardiovascular, cerebrovascular, and peripheral vascular AEs occurred in 6%, 3%, and 2% of pts (drug-related: 2%, 1%, 1%)."
Who is right? Whom to believe?
Should not the FDA and Ariad explain the unbelievable discrepancy to the public scientifically, mathematically and statistically?
It seems that Araid dare not to challenge the FDA.
What happened between the FDA and Ariad? It does not sound right.
"The drug safety communication and these analyses were not shared with us in advance. The communication stated that approximately 24% of patients in the Phase II PACE trial with a median treatment duration of 1.3 years and 48% in the Phase I trial with a median treatment duration of 2.7 years have experienced serious adverse vascular events.", said Timothy P. Clackson.
"I really appreciate all the information on the event rates for Iclusig, but there just seems to be a pattern where FDA says one thing and then you guys come on the call publicly and say something else. So I'm just wondering, what's the logic of having this debate in a public forum? It just seems like every time you guys do that, they come down hard on you at the next possible opportunity. So I'm just wondering why you think this should be prosecuted in public rather than just in meetings with FDA?", asked Jason Kantor from Crédit Suisse AG.
"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 - from 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.
DonShimoda, do you agree?
BUT, the fact is that they could structure the agreement any damn way they want to, and it's logically possible, and not even unlikely that compensation is in some way contingent on specific disease, time, place, favoring upfront payments over later compensation, etc., in other words, the question of NOT non-sensical.
Sometimes a simple, gracious answer, yes or no, is enough, without editorializing about the poster!
I think a clear clarification is helpful to new comers considering some people purposely make confusion by twisting ARIA facts at times.
I myself is a true believer of Ariad. Thanks to those who answered the question.
jessprokoto's question:
"Since my post reached the IHUB board, I guess I should redefine my question. Besides the $69M development cost and the $520M+ that ARIAD is getting once RIDA is approved, would ARIAD still get anything if RIDA is sold by Merck as a solo drug or in combo with other drug? "
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_A/threadview?m=tm&bn=1315&tid=146170&mid=146202&tof=10&rt=2&frt=2&off=1
You do not have to respond to jessprokoto's "lowest common denominator" question (in your words). I hope other people would answers jessprokoto.
What is the proof of your "Of course", please?
Care to answer about RIDA combo? -- jesse prokotok
do we have a piece of the pie for the RIDA combo or is it all Merck's?
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_A/threadview?m=tm&bn=1315&tid=146170&mid=146170&tof=11&frt=2
Bullish Harami Pattern for Ariad Pharmaceuticals (ARIA)
http://www.mysmartrend.com/news-briefs/candlestick/smartrends-candlestick-scanner-detects-bullish-harami-pattern-ariad-pharmace
Instititional holdings of ARIA were up in the 1st and 2nd quarters as the results of "Funds Dumping", right?
Institutions are grabbing ARIA shares from the weak hands,
similar to what happened towards the end of March (FMR purchased 15m+ shares).
Buying Pressure in Shares of ARIA
SmarTrend Detects Continued Buying Pressure in Shares of Ariad Pharmaceuticals (ARIA):
http://www.benzinga.com/press-releases/10/09/c484099/smartrend-detects-continued-buying-pressure-in-shares-of-ariad-pharmace#
Nice Try!
I think saturnxyz means those hedge funds that shorted ARIA.
I suppose you are telling the true saying you are also looking forward to ARIA short squeeze. You see, you and I have been agreeing with each other for the whole day today.
If short squeeze does not happen tomorrow, there will be days after. It just a matter of time. Be happy! Let's cheer!
I look forward to Ariad news that triggers short squeeze.
Short squeeze will happen sooner or later. News tomorrow?
Explanation: Barron's writers/editors are all interns as you disclosed.
Because Barron's writers/editors are all interns.
"Barron's writer's must be interns.", said BiotechHedge.
Are Barron's editors interns, too?
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_A/threadview?m=tm&bn=1315&tid=145940&mid=145947&tof=22&rt=1&frt=1&off=1
The grade was actually based on 26 factors, Earnings Surprise was only one of the 26:
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_A/threadview?m=tm&bn=1315&tid=146032&mid=146034&tof=1&rt=1&frt=1&off=1
After options-expiration, Will ARIA break $4.00?
You are looking forward to RIDA's success while others are wishing the opposite.
"We have had a productive start to the year with substantial progress advancing each of our internally discovered drug candidates and the successful completion of our revised agreement with Merck on the development, manufacture and commercialization of ridaforolimus, our investigational mTOR inhibitor," stated Harvey J. Berger, M.D. chairman and chief executive officer of ARIAD. "We expect several key business and clinical catalysts during the remainder of 2010, each one with the potential to create significant value for our shareholders."
Did Harvey state that 12 months or more ago? Ridaforolimus failure? What else will you negate ARIA? FMR dumping? Dilution? The CEO ... ?
How long will their coffee take? And how high will they bring ARIA to?
CAN badmouthing ARIAD's CEO and repeatedly Speculating/Fabricating FMR dumping or stock dilution COUNTER/OFFSET the effect of a piece of good news?
From $8 ARIA went own when they first signed the Merck Agreement for Rida. Now ARIA is only $3.69.