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Re: AmpleKind post# 41158

Thursday, 12/12/2013 11:05:58 AM

Thursday, December 12, 2013 11:05:58 AM

Post# of 80490

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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