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The FDA knows more about standard criteria, per which doctors report SAEs, than the clinical trial doctors, at least seems to me. If the FDA does not follow them, it must be intentional with an agenda.
Yes, I don't know what they are. I don't need to know what they are. It does not matter whether I know them or not.
However, it DOES matter if the clinical doctors, Ariad or the FDA does not know what standard criteria are. It will make the matter even worse if they know exactly what they are but they intentionally ignore the standard with an agenda.
When standard criteria get violated, a lot of confusion and questions arise.
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.
Worst of all (and unknown to investors) Berger was engaged in a fight with the FDA over the agency's growing concerns about blood clots and other heart safety side effects tied to Iclusig. Refusing to cooperate with FDA, particularly when the fight involves serious drug toxicity and the safety of patients is a losing game.
Berger lost. Ariad's patients, employees and shareholders lost too. And once again, Berger is one of the most despised CEO in bio-pharma.
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
Any attorney out there considering suing the FDA, SEC or others over the FDA's actions and the SEC's failure to investigate re: Ariad's Iclusig (we'll have a look at Novartis) can reach me. I will be your lead plaintiff. I will bring you others in a class action.
To me, the evidence doesn't point at Ariad management, it points at the FDA, the SEC and possibly Novartis.
Everyone is quick to sue Ariad. The aforementioned trio is where this mess should be blamed.
That Times article is quite telling. 32 experts, experts in CML are up in arms. 530 patients that were at deaths doorstep, 14 die. 14 die, not 530. It is sad 14 people die. 265 would have died for sure without the drug, the other half would have to survive a tricky BM transplant, if they find a donor.
The facts - Novartis is ruthless in protecting its franchises, around the world. Tasigna has similar SAE's just now being revealed. Novartis bribes, cheats, lies at every level around the world, then pay a fine and move on.
- No one can say in reality what causes the SAEs, genetics, the CML disease itself, the advanced stages of the disease, the patient age and condition, a combination of these and other factors. There isn't even agreement that the SAEs are even SAEs. Without Iclusig, cause of SAE namely death is certain, it's CML, and the other medicines tried and failed
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.
If his legal team acts against the FDA, I will vote Harvey Berger for the greatest CEO of all time.
I don't know what exactly the standard criteria per which doctors report SAEs are. However, I believe the FDA knows what exactly they are. If the FDA does not follow them, it must be intentional with an agenda.
"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.
consider all the legal "ammo" the ARIAD legal team now has per the misuse/misapplication/alteration of the definitive terms/standards alone. OMG,..talk about a slam dunk!
Clearly demonstrative of proximate cause for litigation. Know that HB's legal team is well aware of this. Good Post.
"I repeat my willingness to serve as lead plaintiff against the FDA and any co-conspirators discovered.
If biomaven and Gregorio are now scratching their heads on what the h*ll happened, all of sudden this theory doesn't seem so...banal. Some may criticize me all they can, I'm not a top poster, but one not may want to knock heads with those 2. But I do know f*cked up sh*t when it happens.
Nobody better than those 2, and they are starting to suspect something fishy in Denmarkfda."
If one lacks the ability to reason logically and make judgments based on facts, he won't be able to draw the correct conclusion as follows:
It was the FDA that did not follow the SAE-reporting standard criteria.
Complex or not, there are certain standard criteria per which the clinical trial doctors report SAEs as evidenced by an ASH presentation titled "... ... 2-Year Follow-up of the PACE Trial"., in which each SAE-reporting slide is labeled with "per standard criteria".
Either Ariad or the FDA did not follow standard criteria as criticized by Dr. Michael Mauro. Otherwise, where did the enormous SAE rate gulf come from?
Who did not follow standard criteria, Ariad or the FDA?
From the same 2-Year Follow-up of the PACE Trial:
SAE rate reported by the FDA = 24%;
SAE rate reported by the Ariad = 11.8%;
SAE rate reported by the docs = 12%.
The doctors reported the 12% SAE rate per standard criteria.
The researchers had since submitted findings from the PACE trial for publication in the New England Journal of Medicine. 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.
http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=902
Logically reasoning based on facts, you will be able to draw the same conclusion:
It was the FDA that did not follow the SAE-reporting standard criteria.
If mejs was short, there would be no longs.
"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
"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.
It was the FDA that did not follow the SAE-reporting standard criteria.
The doctors stressed that they followed standard criteria when they talked about SAEs. Have you read their presentation titled "Ponatinib ... 2-Year Follow-up of the PACE Trial"? - http://t.co/MP4P3hn3FM
So there must be certain SAE-reporting standard criteria everybody should follow.
You ask
What exactly are the "SAE-reporting standard criteria", and where are they cited?
"... 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
It was the FDA that did not follow the SAE-reporting standard criteria.
What exactly are the "SAE-reporting standard criteria", and where are they cited?
The ASH must've made the FDA look less than pretty.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94244121
The assertion in a prior post, "Doctors know more about Iclusig than the FDA,” is actually true.
According to you, Novartis wants Ariad killed. It's understandable. Do you think the FDA also wants to kill Ariad? Is that the reason why you support the FDA's actions on Iclusig?
Ariad's patients, employees and shareholders lost.
And once again, Berger is one of the most despised CEO in bio-pharma.
Berger lost. Ariad's patients, employees and shareholders lost too.
"We will be stronger than ever in 2014. The best is yet to come," posted dr_harvey_berger on YMB.
"We had a little set back, but we will be stronger than ever in 2014. The best is yet to come."
Ariad CEO HB is patently silly. He even don't know how to count. He cannot tell the difference between an individual doctor and 25 doctors.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94200275
How is your Novartis Ariad killer going?
Dr. Berger is a strong-willed CEO. Where there's a will, there's a way. He will turn things around again as he did in 1999. The poison pill measure is his first step.
"... Worst of all Berger was engaged in a fight with the FDA over the agency's ...", said AF.
“History tells us the only way to build a successful sustainable business in biotech is to believe in your products ...,” explains Ariad's CEO Harvey Berger.
http://www.pmlive.com/pharma_thought_leadership/interview_harvey_berger_and_timothy_clackson,_ariad_509032
"ARIA appears to have the support of its clinicians regarding the drug's safety," said Summer Street.
"“We upgrade ARIA from a Hold to a Buy with a price target of $7 based on the overwhelming support that docs at ASH showed ... ", Stifel Nicolaus’ analyst commented.
When "they come down hard on you" the reality is that they're doing a huge disservice to patients ... Did I mention that I despise bureaucracies?
“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.”
http://www.bostonglobe.com/business/2013/11/13/ariad-presents-recovery-plan-but-can-say-when-leukemia-drug-might-return-market/8RjcsYGb8JSlnJTRyjMULO/story.html
"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
I agree that it has little value because I have a short position and I have jointed a lawsuit against Ariad, wishing to destroy the company. However, I love to quote it and post it here.
Could you tell me why you think the YMB post has little value? Could you teach me what the meaning of the word "Quote" is? Haven't I provided the link to the original post on Yahoo Message Board? Is it necessary for you to tell me that I copied it from the Yahoo Message Board?
"We had a little set back, but we will be stronger than ever in 2014. The best is yet to come."
Sentiment: Strong Buy"
By dr_harvey_berger • Oct 18, 2013 8:49 PM
Dr. Berger is a strong-willed CEO. Where there's a will, there's a way. He will turn things around again as he did in 1999. The poison pill measure is his first step.
Berger was engaged in a fight with the FDA ...
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 Boston Globe news, Nov. 13, 2013
"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?"
Dr. Michael Mauro 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.”
http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=902
"We had a little set back, but we will be stronger than ever in 2014. The best is yet to come."
Sentiment: Strong Buy"
By dr_harvey_berger • Oct 18, 2013 8:49 PM
Dr. Berger is a strong-willed CEO. Where there's a will, there's a way. He will turn things around again as he did in 1999. The poison pill measure is his first step.
Should HB file a lawsuit against the FDA's intentional attacks on the company's lifesaving drug Iclusig, I would vote him for the Best Biotech CEO.
Worst of all Berger was engaged in a fight with the FDA over the agency's growing concerns about blood clots and other heart safety side effects tied to Iclusig. - AF
Motley Fool's classical negative comments may help you:
Ariad hopes for a change of heart from the FDA
Ariad Pharmaceuticals (NASDAQ: ARIA ) is trying to convince the FDA that its blood cancer drug, Iclusig, should be allowed back on the market after being pulled due to excessive risk of blood clotting. The drug is still on the market in Europe, however, after the European Medicines Agency, or EMA, put forth a set of guidelines for the drug's use. Ariad is hoping for a similar decision from the FDA next year.
My take is that the best Ariad can hope for is that Iclusig is allowed back on the market as a therapy of last resort. The FDA pulled the drug for safety concerns, and it's unlikely to do a complete about face. And now the EMA is also indicating it needs to further assess the drug's safety profile, which is unwelcome news for Ariad investors. So it's looking like the EMA is more likely to have a change of heart than the FDA.
"Actually with stupid comments like that, no one is going to take it seriously. FDA didn't change AE definition," posted jq1234.
"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.
"Why was the change in the FDA methodology? Where did that come from?", asked Michael J. Yee, RBC Capital Markets.
"Per standard criteria, SAE = AE reported as serious by the investigator" - http://t.co/MP4P3hn3FM
Dr. Michael Mauro 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. ”
http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=902
"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
"Our discussions with physicians as ASH were universally positive regarding the risk/benefit for Iclusig and indicating continuing demand for the drug as a 3rd line agent for CML. We forecast resumption of commercial distribution in the US in 2Q14 with a black box warning label indicating increased risk of CV events, in line with the November EMA recommendation of risk factor assessment before treatment and monitoring during treatment.,” Stifel Nicolaus’ analyst commented.
http://tickerreport.com/banking-finance/87849/ariad-pharmaceuticals-rating-increased-to-buy-at-stifel-nicolaus-aria/
Getting crushed in pre-market.
Yes, she's losing steam rather quickly.. surprising.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94830731
Who is losing steam rather quickly? FMR?
Fidelity continues to buy and hold ARIA after the big plunge. It seems that the largest mutual fund is very confident on Ariad.
Sarissa bought 11.5 million shares; Camber Capital 10 million shares; FMR added 7.8 million shares, totally holding 27,392,509 shares.
They know what they own, don't they?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94759638
I had also been thinking that FMR would sell all of its ARIA holdings before I saw the 13G filling on Nov. 8. Fidelity sold all in 1999 because of Ariad's bad financial situation. However, it has turned out that Fidelity keeps buying and holding ARIA shares this time.
Fidelity is confident on Ariad, isn't it?
Thanks again, biotech_researcher.
Grandma, you really do not have a clue how much Fidelity still has. The investment firm filings you are looking at are for the end of the 3rd quarter, which was before the blow up in early October. Holdings for mutual funds and investment firms in the 4th quarter will be revealed 45 days after the end of the quarter, or around February 15th. So, any statement you make as far as holding by Fidelity are meaningless, and you are wasting your time. I would think with the volumes we saw traded, day after day, Fidelity most certainly lightened their load substantially.. But, have fun..
What characterize the French study are the obvious bias and caveats, and the small size and the relative heterogeneity of its cohort, which the French investigators admit before they make their conclusion.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94774803
Summer Street:
"ARIA appears to have the support of its clinicians regarding the drug's safety. The larger challenge will be the label changes and REMS program as they work with the FDA. We believe the drug provides a clear unmet need and will return in time."
Summer Street maintained an Neutral rating on ARIAD Pharmaceuticals (NASDAQ: ARIA). A consultant with the firm said there was no new information from the PACE data at ASH. For analyst Carol Werther, that can be taken positively or negatively.
http://www.streetinsider.com/Analyst+Comments/ARIAD+Pharma+(ARIA)%3A+No+New+Information+From+PACE+Data+at+ASH+-+Summer+Street/8963679.html
Stifel Nicolaus Upgraded: Buy - 12/10/2013.
Stifel Nicolaus upgraded ARIAD Pharmaceuticals (NASDAQ: ARIA) from Hold to Buy.
http://www.streetinsider.com/Hot+Upgrades/Stifel+Nicolaus+Upgrades+ARIAD+Pharmaceuticals+(ARIA)+to+Buy/8962667.html
Each 15 mg/day reduction in dose intensity results in a predicted reduction of ~40% in the risk of an arterial thrombotic event.
http://t.co/MP4P3hn3FM
A predicted 40 percent decrease in SAEs with a 15 mg. reduction in dose while maintaining efficacy is fantastic news if true.
... Moreover, the statement in question pertains to arterial thrombotic SAEs, not SAEs in general.
I am patently silly and stupid, I have to admit.
I am patently silly as pointed out by DewDiligence => http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94200275
And I am stupid as pointed out by jq1234 => http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94483733
I patently sillily believe DewDiligence is interested in killing Ariad. And I stupidly believe jq1234 speaks for Novartis.
I don't listen to the analysts because I think some of them are truly paid pumpers/bashers, e.g., Rachel McMinn and the BMO analyst.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94808455
I've never listened to the BMO analyst and the BAC analyst. Instead, I'd rather listen to Ariad CEO Harvey Berger.
I can't agree more, very well articulated,
BMO was by far the biggest cheerleader for Ariad.
I, patently silly, don't think vidpok45 added the following contents although he did say "A predicted 40 percent decrease in SAEs with a 15 mg. reduction in dose while maintaining efficacy is fantastic news if true."
– A 15 mg reduction in average daily dose intensity is predicted to lead to ~40%
reduction in the risk of arterial thrombotic events
– While predicted MCyR rates decrease with reduced dose intensity, substantial
responses (predicted and observed) occurred at lower doses. In addition, pts
who dose reduced after achieving MCyR were able to maintain response
http://congressposters.ariad.com/downloads/packages/37/ASH2013_PACE_DoseMod_poster_FINAL.pdf
ARIA’s poster did not include the phrase, while maintaining efficacy in the statement you referenced; you added that.