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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.
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.
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:
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.
Logically reasoning based on facts, you will be able to draw the same conclusion:
If mejs was short, there would be no longs.
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
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?
"We will be stronger than ever in 2014. The best is yet to come," posted dr_harvey_berger on YMB.
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?
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?
Motley Fool's classical negative comments may help you:
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.
Summer Street:
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
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, 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."