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Biotech / Medical : ARIAD Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?


To: Biomaven who wrote (2932)11/3/2013 4:44:58 PM
From: GregorioAllegri  Read Replies (1) | Respond to of 4474
 
That is what I would like to know as well.

I think what jq1234 is telling us is that the FDA 48% number for the phase I is not cardio events, but is everyone who left the trial for drug intolerance for any reason in over the 3 years of the trial, including those who died for drug unrelated reasons or perhaps even from CML. If so, the FDA wording is worse than ambiguous, it reads like fear mongering - like someone with an agenda. Considering these were very sick people to begin with, considering that Bosulif has an 11 mo median time to progression, the fact that over half are still on ponatinib with complete remission after 2.7 years is a big time twist on what is in the FDA communique, and makes me think that I have been had. I just don't know by whom yet...

ga



To: Biomaven who wrote (2932)11/6/2013 9:18:05 AM
From: Zohar_Power  Read Replies (1) | Respond to of 4474
 
Could be a change in how many are considered "attributable" to the drug vs being hereditary or environmental hypertension, weight-related, etc. It's hard to tell how many very sick middle-aged/Elderly people with high blood pressure had it go up due to a drug or due to disease progression or other factors.