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terragord7

12/09/13 10:04 PM

#40946 RE: jochenVt #40944

Check yahoo and twitter seems great results
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Moanrch

12/09/13 10:12 PM

#40947 RE: jochenVt #40944

BMO Today:
Our View:
1) Durability of ICLUSIG response in the salvage setting, in particular for patients with T315i mutation and few treatment options, is impressive but serious thrombotic and vaso-occlusive events remain a concern.
2) While ARIA has modeled a 40% reduction in thombosis/vaso-occlusive event risk for every 15mg reduction in dose, we would note that ARIA data interpretation has diverged widely from FDA.
3) With focus on prospects for re-introduction of ICLUSIG distribution, ARIA has indicated regular dialogue with FDA but we continue to expect an ODAC panel review before ICLUSIG comes back, and see real risk that additional clinical trial(s) will be required.
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vidpok45

12/09/13 10:30 PM

#40949 RE: jochenVt #40944

The numbers reflect the vast majority of patients stayed in remission despite the lowering of the dose by 15 mg. Is certainly a fantastic result given the potential 40 percent lowering of the arterial thrombotic saes which constitute the most serious saes ( my words). While venous thrombotic events are serious they are likely less problematic in terms of percentages of overall saes and also likely managed well via coumadin, plavix, and similar agents. Heart attacks, strokes, and Ischemic events resulting in limb loss all are all arterial events however, so I don't understand why this news of a 40 percent reduction in these events via a 15mg dose reduction isn't considered a fantastic possibility as discussed by the poster...it is exactly what many of us except the shorts here were praying for.