Ariad Pharmaceuticals Inc fka ARIA

[grandma_of_jbraika]

The doctors stressed that they followed standard criteria when they talked about SAEs. Have you read their presentation titled "Ponatinib ... 2-Year Follow-up of the PACE Trial"? - http://t.co/MP4P3hn3FM

So there must be certain SAE-reporting standard criteria everybody should follow.

You ask

What exactly are the "SAE-reporting standard criteria", and where are they cited?

I don't know what exactly they are, but I did tell you where they are cited in my previous post. They are cited repeatedly by the doctors in their presentation titled "... ... 2-Year Follow-up of the PACE Trial".

As Dr. Michael Mauro criticized,

"... 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

If both the FDA and Ariad had followed the same standard SAE-reporting criteria, there would not have been the different interpretation of SAES based upon the same raw data.

Whose SAE rate interpretation is on par with or close to the doctors', Ariad's or the FDA's? I believe you know the answer.

The SAE rates reported by the EMA were also much lower than what the FDA had reported:
http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=902

To read more, please go to: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94742315

Using your logically reasoning, you will agree with me on the following conclusion:

It was the FDA that did not follow the SAE-reporting standard criteria.

You have falsely accused me of accusing the FDA and moving the goal posts.

It seems that you're the one moving the goal posts.

Please be kind and advise me more. Thank you!