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grandma_of_jbraika

12/16/13 7:26 AM

#41377 RE: grandma_of_jbraika #41373

"There are many ways of reporting the safety data from a dataset that includes clinical trials with multiple observation points as well as the experience of commercial patients," said DewDiligence

The FDA has the authority to have the safety data reported the way it wants in order to justify its action. This is probably what in DewDiligence's mind. DewDiligence supports the FDA's action, doesn't he? So does Novartis and the other poster who always speaks for Novartis.

Has DewDiligence been ever positive on Ariad?

There are many ways of reporting the safety data from a dataset. Dew is right. At least there are 2 ways, I have observed.

One way is to follow standard criteria and categorize adverse events scientifically as the clinical trial doctors and Ariad have done.

Another way is to intentionally violate standard criteria and create confusion and questions as the FDA has done to Iclusig, as the result of which, a lifesaving drug can be withdrawn, the lifesaving drug company can be destroyed, doctors fear their patients are going to die, and patients panic.
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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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DewDiligence, how is your Novartis Ariad Killer going?
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grandma_of_jbraika

12/22/13 5:07 PM

#42321 RE: grandma_of_jbraika #41373

Dew, do you agree with Hans Loland? He believes doctors know more about Iclusig than the FDA.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?

I also believe doctors know more about Iclusig than the FDA and Dew. Am I patently silly?

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