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Re: biotech_researcher post# 41141

Thursday, 12/12/2013 9:31:57 AM

Thursday, December 12, 2013 9:31:57 AM

Post# of 80490

Worst of all Berger was engaged in a fight with the FDA over the agency's growing concerns about blood clots and other heart safety side effects tied to Iclusig. - AF

I would vote Harvey Berger for the Best Biotech CEO should he file a lawsuit against the FDA's intentional attacks on the company's lifesaving drug Iclusig.

Aren't there any standard criteria for reporting SAEs? What's the purpose of the change in the FDA methodology?

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