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grandma_of_jbraika

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grandma_of_jbraika

Re: DewDiligence post# 41353

Sunday, 12/15/2013 8:59:55 PM

Sunday, December 15, 2013 8:59:55 PM

Post# of 80490

"SAE = AE reported as serious by the investigator, per standard criteria"
http://t.co/MP4P3hn3FM

Source: Ponatinib in Patients with CML and Ph+ ALL Resistant or Intolerant to Dasatinib or Nilotinib, or with the T315I BCR-ABL Mutation: 2-Year Follow-up of the PACE Trial

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.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94970959
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