Interesting, will have to wait and see what happens with the approval process. I'd imagine it would have to come down from 234K for the PBS. I'd always imagined it would have to be priced at some multiple of average hospital admission costs to make it practical - which as I understand it are...
Thanks for the updates GenH. I'm incredibly intrigued as to how Vertex will try and price Kalydeco in Australia. Let's hope for a smooth approval process.
saveferris2009, this has definitely put the heat back on Vertex. I do find it interesting that some of the issues people have been highlighting are in this release. If it's possible, the final results are now even more hotly anticipated.
Vertex has released some corrected results from the trial, with the results not quite as good as previously thought. <a title="http://investors.vrtx.com/releasedetail.cfm?ReleaseID=677520 "...
Rainsmom, on the call I think they said they were waiting for the full results to try and understand the inconsistency that you pointed out. trw144, you are spot on. We certainly can't make accurate comparisons at this stage, all we can take from this is that the results are promising enough to...
Rainsmom, on the call I think they said they were waiting for the full results to try and understand the inconsistency that you pointed out. trw144, you are spot on. We certainly can't make accurate comparisons at this stage, all we can take from this is that the results are promising enough to...
That's a good question. My interpretation was that those that saw the 10% increase were a part of the 17. So only 46% saw an improvement. The other 54% increased by less than 5%. I certainly could be wrong though - and hope I am. Analysts were pressing for an average FEV1 increase (mean) which...
That's a good question. My interpretation was that those that saw the 10% increase were a part of the 17. So only 46% saw an improvement. The other 54% increased by less than 5%. I certainly could be wrong though - and hope I am. Analysts were pressing for an average FEV1 increase (mean) which...
I agree bigstar. The only negative is the sweat chloride levels compared to the significant changes we saw with 770 and G511D. Is certainly good news that FEV1 levels were comparable though.
Will be interesting to see the sweat chloride results from the 2a 661 trial. They shouldn't be far away...
I agree bigstar. The only negative is the sweat chloride levels compared to the significant changes we saw with 770 and G511D. Is certainly good news that FEV1 levels were comparable though.
Will be interesting to see the sweat chloride results from the 2a 661 trial. They shouldn't be far away...
Yeah I think that's what they are saying Rebjane.
Will include all the different breakdowns for dosage and time and results for both single DF508 and the double delta's.
Yeah I think that's what they are saying Rebjane.
Will include all the different breakdowns for dosage and time and results for both single DF508 and the double delta's.
Finally from the call,
Similar level of sweat chloride reductions compared to the earlier studies, but there is no correlation between FEV1 and sweat chloride. FEV1 is what they are focused on.
Accelerated approval is something they'll be discussing with FDA.
Can't comment on what's more...
Finally from the call,
Similar level of sweat chloride reductions compared to the earlier studies, but there is no correlation between FEV1 and sweat chloride. FEV1 is what they are focused on.
Accelerated approval is something they'll be discussing with FDA.
Can't comment on what's more...
They also said, no reason the current results shouldn't be maintained over the duration of the trial. A 10% increase in FEV was about what they saw in phase 3 trials of 770 for G511D. Moving forward as quickly as possible with further studies to get drug combos to market.
They also said, no reason the current results shouldn't be maintained over the duration of the trial. A 10% increase in FEV was about what they saw in phase 3 trials of 770 for G511D. Moving forward as quickly as possible with further studies to get drug combos to market.
From listening to the conference call, they said the results exceeded expectations.
Didn't release results of the single F508 del as not enough patients have completed enough of the study.
From listening to the conference call, they said the results exceeded expectations.
Didn't release results of the single F508 del as not enough patients have completed enough of the study.
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