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Post by peppy on Jan 26, 2016 12:38:08 GMT -5
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Post by Deleted on Jan 26, 2016 12:44:17 GMT -5
its just 46 patients
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Post by esstan2001 on Jan 26, 2016 12:58:28 GMT -5
Sanofi's interests are no longer aligned with ours- they can not be permitted to run this trial. As we take it back, I am hoping that the protocol can be amended in some manner to allow a test for superiority, to get a better indication on the label ASAP. |
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Post by peppy on Jan 26, 2016 13:00:16 GMT -5
it was/is phase 1 a safety/dosage, trial.
as near as I can tell.
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Post by esstan2001 on Jan 26, 2016 13:24:18 GMT -5
it was/is phase 1 a safety/dosage, trial. as near as I can tell. From the study: Secondary Objectives: To assess the ability to titrate the prandial and supplemental doses of Afrezza at each meal. To assess pharmacokinetics (PK) following a prandial dose of Afrezza in children ages 4 to 17 years with T1DM. It is here that I hope we can leverage our leeway into something useful to the label. |
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Post by peppy on Jan 26, 2016 13:34:37 GMT -5
it was/is phase 1 a safety/dosage, trial. as near as I can tell. From the study: Secondary Objectives: To assess the ability to titrate the prandial and supplemental doses of Afrezza at each meal. To assess pharmacokinetics (PK) following a prandial dose of Afrezza in children ages 4 to 17 years with T1DM. It is here that I hope we can leverage our leeway into something useful to the label. I hear you esstan, I could be wrong, from my reading, dosage and safety are a phase 1 objective, a label change that could happen is safe for children. The best thing here is the Continuous glucose monitors on the 46 youth. Pictures, like a continuous x ray of sorts.
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Post by dreamboatcruise on Jan 26, 2016 15:06:19 GMT -5
... At that point it becomes questionable whether doing it as part of the pediatric study would have any merit vs simply doing it separately with all ages involved. It's amazing how easy it is to overlook reality (what we should know the FDA requires) in order to engage in wishful thinking, such as I did on hearing CGMs were involved in pediatric... I'm trying to learn lessons from past mistakes. The one thing we can still hope is that perhaps they clear up the dosing timing issue. If I'm correct about how they are blinding this test, they could still have each delivery route used at the appropriate time for its active ingrediant... injection 15 min before meal and inhale after start of meal. Hopefully. Though, perhaps the FDA really would want apples to apples to replicate adult trial. The reason I'd like to see another arm added to the study (I assume it has to stay pediatric, as it is titled as such) that could show superiority, is time.
To at least be able to claim superiority for kids by some time later this year, I think many PWD would assume hey, if it works better for kids, why wouldn't it also work better for adults... An adult superiority study is another study, more money, and has to get through the whole process (more time). Pedi is almost ready to run. I'd take a 2-3 month delay to get some superiority test into the trial. To me the faster we can make any better (even incrementally so) claims on the label, the sooner the fog lifts. If doing a tack on is shorter than simply a new trial then I'd fully agree with you. I would have expected that the time to add a totally different protocol to the pediatric trial involving dosing/titration based on CGM would take as long as simply getting it approved as separate trial... but that may well be incorrect assumption. |
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Post by fofos2000i on Feb 19, 2016 4:17:28 GMT -5
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Post by yash on Feb 19, 2016 4:23:49 GMT -5
Thanks fofos for sharing.
But quite contradictory.
After dropping Afrezza, SNY should be in process of handing over to MNKD by 5th of April.
Is SNY trying to prove that they did their best to avoid legal case or are they are still involved and handing over is from MNKD to SNY?
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Post by kc on Feb 19, 2016 4:42:20 GMT -5
The answer to who is doing the study. |
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Post by agedhippie on Feb 19, 2016 8:50:29 GMT -5
Thanks fofos for sharing. But quite contradictory. After dropping Afrezza, SNY should be in process of handing over to MNKD by 5th of April. Is SNY trying to prove that they did their best to avoid legal case or are they are still involved and handing over is from MNKD to SNY? The handover does not commence until the end of the contract and the start of the transition phase. Until then Sanofi are responsible for the trials so they will continue as before. |
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Post by matt on Feb 19, 2016 9:23:00 GMT -5
As we take it back, I am hoping that the protocol can be amended in some manner to allow a test for superiority, to get a better indication on the label ASAP. Usually a superiority outcome is shown with the same protocol used with different products in a randomized trial. With such a small sample (and 46 is very small) MNKD will be unable to show superiority.
Trials that show superiority have to go head to head against some other treatment that is known to work (insulin pens for example). We all know injected insulin works pretty well so to prove statistically at the 95% confidence interval (the same as p < 0.05) there must be enough patients that do substantially better on Afrezza than the comparator arm. While HbA1c is an important test, you are not going to get a label change simply by showing a difference in one test parameters. The reason you need such a large trial is because injected insulin does work pretty well, and the trial is all about showing the patients that do worse on injections but do better on Afrezza (minus the patients that do better on injected versus worse on Afrezza), as measured on a number of test and functional parameters. Most metabolic disease trials have 2,000+ patients simply because of the inherent statistical noise factor, and that gets expensive.
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Post by tayl5 on Feb 19, 2016 9:44:23 GMT -5
Thanks fofos for sharing. But quite contradictory. After dropping Afrezza, SNY should be in process of handing over to MNKD by 5th of April. Is SNY trying to prove that they did their best to avoid legal case or are they are still involved and handing over is from MNKD to SNY? The handover does not commence until the end of the contract and the start of the transition phase. Until then Sanofi are responsible for the trials so they will continue as before. While we may not be impressed with Sanofi's overall efforts on behalf of Afrezza, no doubt there are many in the Sanofi organization who have given their best efforts and will continue to do so until the conversion date or until they are specifically ordered to stand down. We should not assume that every action on the part of the company is coordinated by the C-suite as part of a campaign to influence how the company is perceived by lawyers, investors and prospective partners. |
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Post by Deleted on Feb 19, 2016 9:46:30 GMT -5
The handover does not commence until the end of the contract and the start of the transition phase. Until then Sanofi are responsible for the trials so they will continue as before. While we may not be impressed with Sanofi's overall efforts on behalf of Afrezza, no doubt there are many in the Sanofi organization who have given their best efforts and will continue to do so until the conversion date or until they are specifically ordered to stand down. We should not assume that every action on the part of the company is coordinated by the C-suite as part of a campaign to influence how the company is perceived by lawyers, investors and prospective partners. Im sure there were many SNY employees that were friends of Al's that had no idea they were going to knife him in the back. |
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