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Euripides90

12/12/13 10:42 AM

#41160 RE: AmpleKind #41158

Agreed, just saw this comment: you should add your own!

lu
• 3 minutes ago

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Vijay Samant and Ha Ngoc allegedly according to this summation knowingly harmed patients by unethically-run trials, "put them in harm's way," while Harvey Berger of ARIA is worst case the Charlie Sheen of the group, too impassioned and needs a little "anger management" per this article or maybe just a soupcon of diplomacy.

TOTALLY UNFAIR TO PUT HIM IN THIS GROUP, anger against him and the votes must come from people who lost a lot of money and need any target to lash out at.

At the recent ASH/ hematology conference just ended independent reports are that the near-unanimous opinion of the physicians is that the company's drug Iclusig should never have been pulled by the FDA and the FDA will have no choice but to put it back on market albeit with more guidelines b/c without it many patients will die.
That is something Harvey Berger may have just become too impassioned about.
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grandma_of_jbraika

12/12/13 11:05 AM

#41163 RE: AmpleKind #41158

Berger was engaged in a fight with the FDA ...

It could be true given AF has a buddy at Ariad.
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Ariad fears that the FDA has "created a lot of confusion and questions” among doctors and patients:

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

Crédit Suisse analyst Jason Kantor asked Ariad at the 2013 3Q Earnings Call:

"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







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vidpok45

12/12/13 12:37 PM

#41177 RE: AmpleKind #41158

Excellent post Amp It is a shame this board has been taken over by daytraders giving us pieces of their mindless drivel. This company and its stock will slowly come back and that crowd will then go back to yahoo where they belong.
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lax20m

12/12/13 2:59 PM

#41182 RE: AmpleKind #41158

He didn't take a survey before he wrote the article but the article contains a survey and guess what Berger is one of the top vote getters!