Ariad Pharmaceuticals Inc fka ARIA

[grandma_of_jbraika]

The FDA knows more about standard criteria, per which doctors report SAEs, than the clinical trial doctors, at least seems to me. If the FDA does not follow them, it must be intentional with an agenda.

Yes, I don't know what they are. I don't need to know what they are. It does not matter whether I know them or not.

However, it DOES matter if the clinical doctors, Ariad or the FDA does not know what standard criteria are. It will make the matter even worse if they know exactly what they are but they intentionally ignore the standard with an agenda.

When standard criteria get violated, a lot of confusion and questions arise.

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.

I agree with Clackson. Ariad is obligated to stay with the standard. This is probably what Adam Feuerstein is talking about.

Worst of all (and unknown to investors) 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. Refusing to cooperate with FDA, particularly when the fight involves serious drug toxicity and the safety of patients is a losing game.

Berger lost. Ariad's patients, employees and shareholders lost too. And once again, Berger is one of the most despised CEO in bio-pharma.

Unfortunately, the FDA came down hard on Ariad as observed by Crédit Suisse analyst Jason Kantor.

If Harvey Berger's legal team acts against the FDA, I will vote him for the greatest CEO of all time.

Ariad's patients, employees and shareholders lost because the FDA, with an agenda, did not follow standard criteria per which the clinical doctors reported SAEs as criticized by Michael Mauro:

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, 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. That’s a lesson this experience has taught us.”
http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=902