Replies to post #41371 on Ariad Pharmaceuticals Inc fka ARIA

[grandma_of_jbraika]

Standard criteria per which docs report SAEs is not the same thing as stand nonsense per which the FDA reported Iclusig SAEs. You are right.

Standard criteria for adverse events is not the same thing as a standard format for reporting them.

Have I ever talked about the so-called standard format? Never! Why are you changing the topic?

What really matters is the criterion rather than the format. As long as the standard criteria are followed, 12%, or TWELVE PERCENT in a nonstandard format makes no differences.

However, if standard criteria get violated, 12% can be exaggerated to 24% per stand nonsense, or TWENTY FOUR PERCENT in a standard format.

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

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.

When standard criteria get violated, a lot of confusion and questions arise.

I agree with Clackson. Ariad is obligated to stay with the standard. This is probably the so-called "fight with the FDA" Adam Feuerstein is talking about.

Unfortunately, the FDA came down hard on Ariad as observed by Crédit Suisse analyst Jason Kantor.

Berger needs to fight harder with the FDA and carefully explain what have happened in the courtroom.
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If Harvey Berger's legal team acts against the FDA, I will vote him for the greatest CEO of all time.
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Dew, please continue your exchange convincingly. I believe you can.

[grandma_of_jbraika]

Dew, please teach us about standard formats for reporting SAEs. Is a standard format more crucial than standard criteria? If so, why did the doctors report SAEs per standard criteria without mentioning any standard formats? Are the clinical trial doctors patently silly?

Standard criteria for adverse events is not the same thing as a standard format for reporting them.

What really matters is the criterion rather than the format, which I patently sillily believe.

Details: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94997236
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The FDA knows more about standard criteria, per which doctors report SAEs, than the clinical trial doctors, at least it seems to me. If the FDA does not follow them, it must be intentional with an agenda.

And Doctors know more about Iclusig than the FDA, I believe patently silily.