Ariad Pharmaceuticals Inc fka ARIA

[grandma_of_jbraika]

From: Biomaven

It's just weird when you compare the FDA analysis (and that of the French trial), with the frontline trial reported, which showed major molecular response (MMR) in 74% of patients, with the drug described as "well tolerated" and 7% hypertension being the only reported cardiovascular AE.

Peter -- http://www.siliconinvestor.com/readmsg.aspx?msgid=29270286

Even Biomaven find the delta weird.

The French-Cortes delta is not so weird as the FDA-Cortes delta in my opinion.

Comparing the French trial with the Cortes frontline trial is somewhat comparing apples and oranges. What characterize the French study are the small size and the relative heterogeneity of its cohort, the obvious caveats and the obvious bias of such a study, which the French investigators admit before they make their conclusion.

The weird FDA-Cortes delta is from analyzing the identity raw data of the same apples.

"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," said Michael J. Mauro, MD, Leader of the Myeloproliferative Diseases Program at Memorial Sloan-Kettering Cancer Center who was an investigator on both the drug’s Phase I and II trials. “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

One of the 2 parties must've changed the SAE definition intentionally. The FDA officials, the Ariad employees and Dr. Cortes together with other doctors are not idiots, are they? Don't they know the definition of SAE?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94742315
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I dare to disagree with Biomaven because I am "Patently Silly" and "Stupid" as pointed by some wise men who support the FDA's actions and have an interest in killing Ariad.