Replies to post #40704 on Ariad Pharmaceuticals Inc fka ARIA

[grandma_of_jbraika]

"To boost their claim, the FDA listed in a press release the events of some rather unfortunate side effects to illustrate their point, ignoring that the very ill patients had other conditions besides CML, notably diabetes, that could very well have been the leading cause of those SAEs. In some cases, the FDA points out at least two patients in their 20's who experienced FDA-defined SAE's, ignoring to state in their press release these patients were in the end state, or blast phase of the disease, with no alternative treatment than Iclusig. The drug saved one, the other sadly did not respond to treatment. Few of these very ill patients actually die from a SAE while the hundreds and hundreds of patients are alive today because of Iclusig.

Immediately after asking (forcing) Ariad to stop selling the drug, the FDA told existing patients that they could apply through the FDA so that Ariad would provide the drug for free. And that is on-going. Nothing has changed, except that this upstart biotech, Ariad, is slowing going out of business by keeping these desperate patients, who were paying for the drug, alive with free drug.", 2damoon1 wrote.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94092550

[grandma_of_jbraika]

"To boost their claim, the FDA listed in a press release the events of some rather unfortunate side effects to illustrate their point, ignoring that the very ill patients had other conditions besides CML, notably diabetes, that could very well have been the leading cause of those SAEs. In some cases, the FDA points out at least two patients in their 20's who experienced FDA-defined SAE's, ignoring to state in their press release these patients were in the end state, or blast phase of the disease, with no alternative treatment than Iclusig. The drug saved one, the other sadly did not respond to treatment. Few of these very ill patients actually die from a SAE while the hundreds and hundreds of patients are alive today because of Iclusig.

Immediately after asking (forcing) Ariad to stop selling the drug, the FDA told existing patients that they could apply through the FDA so that Ariad would provide the drug for free. And that is on-going. Nothing has changed, except that this upstart biotech, Ariad, is slowing going out of business by keeping these desperate patients, who were paying for the drug, alive with free drug.", 2damoon1 wrote.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=94092550

[grandma_of_jbraika]

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

The clinical trial doctors report SAEs per standard criteria.

But are there such standard criteria? If so, shouldn't everybody follow the standard criteria?

Dr. Michael Mauro 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. ”
http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=902

Whom was Dr. Mauro blaming? Who didn't follow the standard criteria, Ariad or the FDA?

"You went through a lot of the differences in how the thrombotic events are counted. I guess, why was the change in the FDA methodology? Where did that come from?", asked Michael J. Yee, RBC Capital Markets.

"I think that's not anything that we can comment on or know. So we're just not really in a position to comment on that.", answered Timothy P. Clackson.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=93998347

What's the purpose of the change in the FDA methodology? Where did that come from?