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Posted On: 11/04/2019 5:28:39 PM
Post# of 148908
Re: DoubleBagger24 #10535
Here is the overall results on 350 given in January.
Here is the results after 10 weeks, these were all was before the long half-life was found and longer overlap was tested with 525mg and 700mg; so these numbers could be higher with the 4 week overlap added.
Here is the paper on phase 2 mono, where most of the failures where shown to have a higher density than those that succeeded.
https://www.tandfonline.com/doi/abs/10.1080/1...ode=yhct20
Anyway, 350mg alone would never had been approved. What the results after 10 week show, if they add the density test to determine the correct dose at the beginning (instead of random), the responder rate even with 350mg can be high (i.e. the failures the first 10 weeks on 350mg have a higher density and would be put on 525mg or 700mg). So the density test, if done correctly could yield numbers close or maybe higher than the >10 week numbers (for 350mg I suspect maybe higher)
When they started this trial though, the KOL as NP said was against it, because the low success rate with 350mg, which was the only dose used at that time. The overall response rate with 525mg jumped significantly and 700mg even higher.
Here is the results after 10 weeks, these were all was before the long half-life was found and longer overlap was tested with 525mg and 700mg; so these numbers could be higher with the 4 week overlap added.
Here is the paper on phase 2 mono, where most of the failures where shown to have a higher density than those that succeeded.
https://www.tandfonline.com/doi/abs/10.1080/1...ode=yhct20
Anyway, 350mg alone would never had been approved. What the results after 10 week show, if they add the density test to determine the correct dose at the beginning (instead of random), the responder rate even with 350mg can be high (i.e. the failures the first 10 weeks on 350mg have a higher density and would be put on 525mg or 700mg). So the density test, if done correctly could yield numbers close or maybe higher than the >10 week numbers (for 350mg I suspect maybe higher)
When they started this trial though, the KOL as NP said was against it, because the low success rate with 350mg, which was the only dose used at that time. The overall response rate with 525mg jumped significantly and 700mg even higher.
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