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ARIA does not need to be pumped to go higher. It may go either up or down next Monday. The short term price fluctuation does not matter to the Ariad true longs.
The CEO's goal is to build Ariad into the next Amgen in spite of the painful set back.
Any news will be good news because Ariad has run out of shoes to drop. Don't you think so? You don't have to count on it. However, Counting on it or not counting on it is at your own risk. You will see what is going to happen.
Ariad has run out of shoes to drop. From now on, any news will be good news.
What happened to Ariad during 10/1999 - 03/2000 will probably be repeated. By 03/2014, ARIA may reach $50+ if history repeats.
History repeats itself, doesn't it?
That poster might have a short position. However, I don't think he/she is a paid basher or alias of a certain offshore poster although this poster has accused others of being a paid pumper or alias of offshore poster.
III is an expert on TA and an honest guy. TA is somewhat useful to traders and investors in different degrees.
I will always be biased (based on my position) on the charts, but I still have to take note of trends and patterns that start to break "the other way".
BAC's Rachel McMinn on Ariad:
Rachel McMinn is another example of paid pumpers and dumpers.
When ARIA rose to $25, she acted as a pumper and raised the price target to $30:
http://www.benzinga.com/analyst-ratings/analyst-color/12/10/2955195/update-bank-of-america-merrill-lynch-reiterates-buy-rati
She, while pumping, once allocated $4 for AP26113 to her $26 price target.
When the flash crash brought ARIA to $4, the same Rachel McMinn lowered the target price to $2 and lowered AP26113's value to ZERO.
What a pumper and dumper she is! Is she paid for her pumping and dumping? Yes! so Rachel McMinn is paid pumper and dumper.
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I have never listened to the BAC analyst and the BMO analyst. Instead, I listen to Ariad CEO Harvey Berger.
Euripides90:"I like how Berger was so certain about ..."
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Harvey Berger is not mejs' cup of tea. He may disagree with me on Dr. Beger. Everybody has his/her own opinions. However, I like civic's posts very much. His predictions may come true. Who knows?
I strongly disagree with lax20m who accused mejs of being a paid pumper. It is unfair and off topic.
BMO is really a paid pumper & dumper with PT=37 & PT=2
I wrote to my friends on October. 4, 2013:
How much should one listen to an analyst?
I suspect BMO pumps and dumps ARIA for SECTORAL ASSET MANAGEMENT, which was the 2nd largest institutional holder of ARIA when BMO initiated ARIA coverage with the far higher price target than average. I guess SECTORAL ASSET MANAGEMENT might have sold most of its holdings (the 7th largest institutional holder as of 06/30/2013) before BMO downgraded ARIA and lowered target price to $21 from $37.
Grandma. If you really are a grandma wouldn't you have better things to do today on thanksgiving.. Are you sure you not some offshore poster with an alias?
lax20m, is lax20m your real name instead of an alias? If so, is lax20m your family name or your given name?
Why did you accuse some poster of being a paid pumper? Is it on topic? Who would pay him to pump Ariad? what's your agenda?
lax20 was off topic interrogating me. Happy Thanksgiving. Go ARIA! Thank you!
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94504077
Letter To FDA's Dr. Pazdur,
https://www.dropbox.com/s/5tvr3rpsjckwa7o/FDA%20letter.ponatinib.11012013.pdf
Any news will be good news because Ariad has run out of shoes to drop. Don't you think so? You don't have to count on it. However, Counting on it or not counting on it is at your own risk. You will see what is going to happen.
Ariad has run out of shoes to drop. From now on, any news will be good news.
What happened to Ariad during 10/1999 - 03/2000 will probably be repeated. By 03/2014, ARIA may reach $50+ if history repeats.
History repeats itself, doesn't it?
Ariad has run out of shoes to drop. From now on, any news will be good news. What happened to Ariad during 10/1999 - 03/2000 will probably be repeated. By 03/2014, ARIA may reach $50+ if history repeats.
History repeats itself, doesn't it?
2damoon1, could you post the contents of your latest complaint to the SEC so that I can make a copy and complain to the SEC, too? Thanks!
These efforts are supportive of discovering the answers to 'what the heck happened'. And, it's better reading than the buy/sell posts of the newer folks. Doesn't hurt anything. And the organization written exist for these sorts of matters.
rurik, do you think Moanrch is long or short? He claims he is neutral.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94501091
What do think my self-interest is? Don't you have your self-interest here? What's it?
I have just reported to HHS OIG using what I wrote before as advised by mejs.
Thanks to mejs and investor maven for the link to the Office of Inspector General, US Dept. of Health & Human Services:
https://forms.oig.hhs.gov/hotlineforms/report-fraud-form.aspx?AspxAutoDetectCookieSupport=1
rurik: "I think that you guys are just annoying people who have much better things to do.
Who in their right mind would listen to shareholders trying to to make some idealistic point when their self-interest is really what they are pushing?"
The FDA Exaggerates SAE rates, which is further evidenced by Cortes and colleagues recently.
Cortes and colleagues wrote. “The incidence of all arterial thrombotic events, serious or not, was 17.1%.”
Without changing the definition of AE, how could the FDA come to its 24% SAE rate? What's is the FDA's purpose of the exaggeration?
"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," commented Richard Parkinson.
Moanrch 1: "I was long for five years, now I'm Neutral, more objective…, bearish."
Moanrch 2: "I was long before the flash crash, now I'm short."
Are Moanrch 1 and Moanrch 2 the same person?
Moanrch 1 labels himself/herself as NEUTRAL. If he/she is a short in disguise, doesn't he has an agenda in disguise? How should the longs take his/her "kind" advices?
Suggest you write your congress person as well
Moanrch, being short or long is perfectly fine as long as one makes money. Are you long or short now?
A poster also named Moanrch honestly told, on Nasdaq.com' Market Stream section a while ago, that he/she was shorting ARIA after the flash crash although he/she had been long on ARIA before the crash. Is he/she the same Moanrch or different one?
I admire anyone who was short before the flash crash. I definitely don't admire anybody who is short now. I don't buy a dishonest short's advices.
jq1234 & iandy, if the FDA hadn't changed AE definition, there wouldn't have been the enormous gulf between the 2 SAE rates (the doctors' 4% vs. the FDA's 24%). The Oct. 9 CC transcripts may also help people find clues and figure it out.
I have reported Fraud to the Office of Inspector General, US Dept. of Health & Human Services. Do you think I am patently silly as Dew thinks??
Following are the contents of what I reported to HHS OIG:
----------------
Please inquire into an evolving situation regarding Ariad Pharmaceuticals, a Biotech company based in Cambridge, MA, and the FDA. The FDA forced Ariad to ‘voluntarily’ withdraw Iclusig, a life-saving drug, due to SAE's.
Are all the SAE's (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 count 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%).
Whose methodology is more scientific, the doctors' or the FDA officials'? Who treat and examine the patients physically? Who know about the safety/toxicity of Iclusig better, the doctors or the FDA officials?
The 2-Year FACE Trial Follow-Up of the Ariad drug by 25 doctors from many countries concludes that "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%)."
Link: https://ash.confex.com/ash/2013/webprogram/Paper59380.html
----
Doctors and patients across the country obviously disagree with the FDA as 23 leukemia specialists and 3 patient advocacy groups immediately sent the FDA a letter saying they were concerned right after the FDA withdrew the life-saving drug Iclusig.
“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.
Link: http://www.nytimes.com/2013/11/02/health/doctors-fear-losing-leukemia-drug-deemed-risky.html?pagewanted=1&_r=4&partner=rssnyt&emc=rss&adxnnlx=1384675370-qFR2pICcxyo2PSRUr7j9Pw
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94392243
Is that honest Moanrch who once honestly posted on another board not the Moanrch here?
The poster who has just negated Ariad 3 times here honestly told, on Nasdaq.com' Market Stream section a while ago, that he/she was shorting ARIA after the flash crash although he/she had been promoting this stock before the crash.
I hope he/she to be honest here as well. Can he/she deny what I am exposing if he/she refuses to be honest? Thank you
Mpanrch, are you long or short now? Would you please be as honest as you disclosed on Nasdaq's "Market Stream" board a while ago?
Yes, "The situation with ponatinib is very difficult" because of the enormous gulf between the 2 heart SAE rates (the doctors' 4% vs. the FDA's 24%).
"Cortes and colleagues observed serious-grade arterial thrombotic events in 8.9% of patients, 2.9% of which were considered treatment-related."
http://www.healio.com/hematology-oncology/hematologic-malignancies/news/online/%7B2b1d6109-030d-42e5-b795-2e678358a6f5%7D/ponatinib-demonstrated-activity-in-patients-with-cml-phall
------------
The 2-Year FACE Trial Follow-Up of the Ariad drug by Cortes et al (25 doctors from many countries) concludes that "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%)."
https://ash.confex.com/ash/2013/webprogram/Paper59380.html
What's your self-interest here, please?
jq1234: "Stupid"; iandy: "Wacky"; Dew: "Patently Silly"; jq1234: "Actually with stupid comments like that, no one is going to take it seriously ...".
Please don't take this the wrong way. I am talking about jq1234's word Stupid, DewDiligence's words Patently Silly and iandy's word wacky.
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iandy, please read my orginal post again. Have I written ", commented Richard Parkinson"? I understand you don't who Richard Parkinson is. Do you know who the article's author is? Does it really matter? I do not know both of them. As a matter of fact, I do not know who iandy exactly is, either. Nevertheless, I still take your comments serious no matter whether I am b]wacky or not.
Link: I replied to a strange post on YMB.
-----
jq1234, I am not sure whether Richard Parkinson's comments are stupid or patently silly in Dew words. How is Novartis' Ariad Killer Dew was talking about to you the other day?
- - -
iandy: "I figured you aren't wacky so I went back and looked in the comments."
- - -
grandma_of_jbraika: "Dew, 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?"
FDA didn't change AE definition? Let's replay Ariad 2013-3Q CC:
"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.
"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.
I have just reported to HHS OIG using what I wrote before as advised by mejs.
Thanks to mejs and investor maven for the link to the Office of Inspector General, US Dept. of Health & Human Services:
https://forms.oig.hhs.gov/hotlineforms/report-fraud-form.aspx?AspxAutoDetectCookieSupport=1
From: cderombudsman@fda.hhs.gov
To: grandma_of_jbraika@xyzabc.com
Subject: RE: Doctors Fear Losing Leukemia Drug Deemed Risky, please inquire
Date: Thu, 21 Nov 2013 14:02:58
Thank you for bringing your concerns to my attention. I will consider the best approach to the issues you raised and respond as soon as possible. If you don’t hear back from me within two weeks, please feel free to write me again.
Virginia
From: Grandma_of_Jbraika [mailto:grandma_of_jbraika@xyzabc.com]
Sent: Wednesday, November 20, 2013 7:15 AM
To: Commissioner FDA (margaret.hamburg@fda.hhs.gov); CDER OMBUDSMAN (cderombudsman@fda.hhs.gov); Behr, Virginia L
Subject: Doctors Fear Losing Leukemia Drug Deemed Risky, please inquire
Dear Dr. Hamburg and Ms. Behr,
Please inquire into an evolving situation regarding Ariad Pharmaceuticals, a Biotech company based in Cambridge, MA, and the FDA.
Are all the SAE's (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 count 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%).
]Whose methodology is more scientific, the doctors' or the FDA officials'? Who treat and examine the patients physically? Who know about the safety/toxicity of Iclusig better, the doctors or the FDA officials?
The 2-Year FACE Trial Follow-Up of the Ariad drug by 25 doctors from many countries concludes that "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%)."
Link: https://ash.confex.com/ash/2013/webprogram/Paper59380.html
--------
Doctors and patients across the country obviously disagree with the FDA as 23 leukemia specialists and 3 patient advocacy groups immediately sent the FDA a letter saying they were concerned right after the FDA withdrew the life-saving drug Iclusig.
“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.
Link: http://www.nytimes.com/2013/11/02/health/doctors-fear-losing-leukemia-drug-deemed-risky.html?pagewanted=1&_r=4&partner=rssnyt&emc=rss&adxnnlx=1384675370-qFR2pICcxyo2PSRUr7j9Pw
Thank you.
Sincerely,
Grandma_of_Jbraika
9 XYZ Street
Boston, MA 02109
"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." commented Richard Parkinson
The FDA's Pazdur should step down and apologize to the patients. Even Obama has apologized to Americans losing health plans. Why shouldn't Pazdur apologize?
"Nominate Dr. Pazdur for the role of Scrooge this season.
Is there anything meaner than denying a life-saving drug? ", said micanwait.
We are trading as if Ariad is about to announce a lawsuit against 1) the FDA, 2) conspirators, 3) certain docs in the study 4) certain wall street types 5) some or all of the above.
We are trading as if Ariad is about to announce a lawsuit against 1) the FDA, 2) conspirators, 3) certain docs in the study 4) certain wall street types 5) some or all of the above.
Shorts seem to be covering, buying seems to be accelerating now.
No resistance to $5.25, then none far ahead.
No blood clots and cardiovascular events were observed at all. Why shouldn't Icusig be brought to the first line?
"Ponatinib As Initial Therapy For Patients With Chronic Myeloid Leukemia In Chronic Phase (CML-CP):
https://ash.confex.com/ash/2013/webprogram/Paper64338.html
Conclustion of the ASH presentation (to be presented on Dec. 7, 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.
The poster who has just negated Ariad 3 times here honestly told, on Nasdaq.com' Market Stream section a while ago, that he/she was shorting ARIA after the flash crash although he/she had been promoting this stock before the crash.
I hope he/she to be honest here as well. Can he/she deny what I am exposing if he/she refuses to be honest? Thank you.
Patients’ advocates press FDA to retain lifesaving drugs, Today's News, the Boston Globe
http://www.bostonglobe.com/business/2013/11/24/lobbying-over-access-blood-cancer-drug-illustrates-growing-clout-patients-with-fda/RHYDXxzSLyAuFynJAYtT4O/story.html
Doctors' data at the 55th ASH will serve as jabs at the FDA. Will the agency turn its shame into anger and vent its anger on Ariad?
Will the FDA strengthen its hardline stance as rumrunner528 is worried about? This is a pattern Crédit Suisse's Jason Kantor has observed.
If the pattern continues, is the government agency supposed to behave this way? Is it ethical and legal?
Doctors will tell the truth about Iclusig's safety/toxicity at the 55th ASH, December 7-10, 2013.Their clinical trial data concludes that Ponatinib is well tolerated and Adverse Events are manageable.
-----
Dr. Richard Pazdur, would you please attend the 55th ASH and see what the data holds?
"We have to see what the data holds," Dr. Richard Pazdur said in an interview. "Any consideration of what we do has to put patient safety first. This is not about getting the drug back to the market so the company can do well."
“The conclusions reached by the CHMP confirm a positive benefit-risk assessment for Iclusig after considering the most recent safety information,” Ariad said.
"At one time we thought the drug had a favorable risk-benefit profile," Dr. Pazdur said. "Now we have to be realistic and say that no longer exists."
"I do believe that, had the situation been handled differently we may not have been attacked so severely as we were by the FDA.", said rumrunner528
"NVS has a CML combo they call the Ariad killer." Conspiracy? Why does Novartis want to murder Ariad?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94360661
That's NOT patently silly.
People are bribed all the time. NVS has so much informal power in the FDA that between its informal power, it's money, it's influence (post FDA careers for many), it documented history of lying, cheating and bribing around the world, I am saying it is entirely possible.
There is no denying Novartis' ruthless behavior to include defense of its most profitable franchise in CML.
CDER Ombudsman:
"I will consider the best approach to the issues you raised and respond as soon as possible. Thank you for bringing your concerns to my attention."
Hans Loland has just posted on YMB: He feels great and life is completely normal. He has been on Ponatinib now for over 4 years, 60mg => 15mg.
http://finance.yahoo.com/mbview/threadview/;_ylt=AutGCqP7z8JTnO7j7wsBs3veAohG;_ylu=X3oDMTB2N2hhYzAyBHBvcwMyNARzZWMDTWVkaWFNc2dCb2FyZHNYSFJVbHQ-;_ylg=X3oDMTBhYWM1a2sxBGxhbmcDZW4tVVM-;_ylv=3?&bn=dfd7468a-c613-386c-9bb4-0872c8ef3b06&tid=1385038504999-0e927bb7-9910-44f6-8777-455aff1b522d&tls=la%2Cd%2C21%2C3
A very educational post of 2a! Can anybody explain what exactly "with a safety profile reflective of the population" means?
Ponatinib has substantial activity in these heavily pretreated Ph+ leukemia pts who have limited available treatment options, with a safety profile reflective of the population. Updated data with a minimum follow-up of 2 yrs will be presented.
What was the FDA spokeswoman doing?
Was she justifying the FDA's forced withdrawal of the life-saving drug? Or was she suggesting that the FDA would come down even harder on Ariad at the next possible opportunity as observed by Jason Kantor at CS?
The Boston Globe news, Nov. 13, 2013:
Ariad fears that the FDA has "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.”
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.
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%).
Conclusions: Ponatinib has substantial activity in these heavily pretreated Ph+ leukemia pts who have limited available treatment options, with a safety profile reflective of the population. Updated data with a minimum follow-up of 2 yrs will be presented.
"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?"
Are all the SAE's 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 count all the AE's as Iclusig-related SAE's, which is probably the root cause of the enormous gulf between the 2 SAE rates (the doctors' 4% vs. the FDA's 24%).
Whose methodology is more scientific, the doctors' or the FDA officials'? Who treat and examine the patients physically? Who know about the safety/toxicity of Iclusig better, the doctors or the FDA officials?
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%).
Conclusions: Ponatinib has substantial activity in these heavily pretreated Ph+ leukemia pts who have limited available treatment options, with a safety profile reflective of the population. Updated data with a minimum follow-up of 2 yrs will be presented.
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.