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Post by centralcoastinvestor on Aug 24, 2017 14:18:36 GMT -5
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Post by centralcoastinvestor on Aug 24, 2017 14:48:01 GMT -5
When the trial is officially launched after recruiting is complete, how much news coverage will this event receive? Will this be considered a milestone event that will help the pps? I hope that Mike C. makes as much headlines as he can.
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Post by sr71 on Aug 24, 2017 14:52:25 GMT -5
From the above-referenced Trial info:
"Estimated Enrollment: 46
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)"
Why would what appears to be largely a 6 week study not be completed until 2021? Even the longest stated secondary outcome branch only goes out 13 months.
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Post by centralcoastinvestor on Aug 24, 2017 14:57:07 GMT -5
From the above-referenced Trial info:
"Estimated Enrollment: 46
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)"
Why would what appears to be largely a 6 week study not be completed until 2021? Even the longest stated secondary outcome branch only goes out 13 months.
Good question. |
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Post by mango on Aug 24, 2017 15:03:24 GMT -5
When the trial is officially launched after recruiting is complete, how much news coverage will this event receive? Will this be considered a milestone event that will help the pps? I hope that Mike C. makes as much headlines as he can. I'm so glad this is finally getting underway. A lot of kids are going to be really happy when they get to use Afrezza. As far as media coverage, I am thinking about this: Make it be known across the nation. MannKind Announces Collaboration with JDRF |
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Post by reality on Aug 24, 2017 15:47:38 GMT -5
From the above-referenced Trial info:
"Estimated Enrollment: 46
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)"
Why would what appears to be largely a 6 week study not be completed until 2021? Even the longest stated secondary outcome branch only goes out 13 months.
Good question. Yes. Good Question. So why? |
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Post by seanismorris on Aug 24, 2017 16:07:02 GMT -5
I seem to remember timetables of 3-6 months. With 6 months being on the long side...
With the timetable that's listed many of the pediatric patients won't be "pediatric" when it finishes...
I didn't see anything "suspicious" when giving it a read through. The only thing I can think of is they're expecting difficulties signing up patients.
But there is 9 locations listed and they only expect 46 patients...weird.
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Post by promann on Aug 24, 2017 16:07:11 GMT -5
From the above-referenced Trial info:
"Estimated Enrollment: 46
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)"
Why would what appears to be largely a 6 week study not be completed until 2021? Even the longest stated secondary outcome branch only goes out 13 months.
It's says a comparison base line from 6- 52 weeks and then it all gets comprised and submitted to the FDA which we all know takes many months |
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Post by seanismorris on Aug 24, 2017 16:11:38 GMT -5
True about the FDA, but this isn't a huge trial and Afrezza is already approved.
I'm hoping it's actually a quick process, and the dates just show that the patients will continue to be on Afrezza and actively monitored.
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Post by matt on Aug 24, 2017 16:44:05 GMT -5
From the above-referenced Trial info:
"Estimated Enrollment: 46
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)"
Why would what appears to be largely a 6 week study not be completed until 2021? Even the longest stated secondary outcome branch only goes out 13 months.
The summary didn't say that it would only be 46 patients; it said the initial cohort enrolled would be 46. This is a first pass through a Phase II study, and 46 subjects is fairly typical for a first Phase II trial, but it will not be enough to satisfy the safety concerns. Expect to see the 46 patients enrolled, then the study will shut down while data is analyzed, and then it will restart with more subjects and a revised protocol that addresses anything unusual seen in the original cohort. That larger group will have much more statistical power and will allow the company to propose different language for the pediatric population, but don't expect to see those revisions until some time in 2021. This will not be a quick process. FDA is very tough on changing label copy and will demand to see compelling data, including absence of adverse events in the original cohort that elect to continue use beyond the initial period. It will be much the same with the other label changes. The FDA based the original wording on the data that Mannkind provided from the original registration trials, so to get that label changed there must be overwhelming evidence that FDA got it wrong the first time. Similarly, with respect to describing Afrezza as "ultra rapid" I don't know that anybody has shown that the rate of absorption is clinically relevant because the onset of activity is the same as lispro. FDA is not going to sign off on a new adjective unless the company requesting the designation shows that there is a meaningful difference to the patient, and I don't think Mannkind has the necessary data because they have not run any large studies since the drug was approved. A limited bridging study on PK alone is not going to be enough. It is up to the company to prove that something is true, it is not up to the FDA to disprove it. Since the default position of the FDA is that nothing is true unless proven to be true, that is a difficult negotiation posture for any company without a ton of data to back up their new claims. |
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Post by peppy on Aug 24, 2017 17:01:57 GMT -5
From the above-referenced Trial info:
"Estimated Enrollment: 46
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)"
Why would what appears to be largely a 6 week study not be completed until 2021? Even the longest stated secondary outcome branch only goes out 13 months.
The summary didn't say that it would only be 46 patients; it said the initial cohort enrolled would be 46. This is a first pass through a Phase II study, and 46 subjects is fairly typical for a first Phase II trial, but it will not be enough to satisfy the safety concerns. Expect to see the 46 patients enrolled, then the study will shut down while data is analyzed, and then it will restart with more subjects and a revised protocol that addresses anything unusual seen in the original cohort. That larger group will have much more statistical power and will allow the company to propose different language for the pediatric population, but don't expect to see those revisions until some time in 2021. This will not be a quick process. FDA is very tough on changing label copy and will demand to see compelling data, including absence of adverse events in the original cohort that elect to continue use beyond the initial period. It will be much the same with the other label changes. The FDA based the original wording on the data that Mannkind provided from the original registration trials, so to get that label changed there must be overwhelming evidence that FDA got it wrong the first time. Similarly, with respect to describing Afrezza as "ultra rapid" I don't know that anybody has shown that the rate of absorption is clinically relevant because the onset of activity is the same as lispro. FDA is not going to sign off on a new adjective unless the company requesting the designation shows that there is a meaningful difference to the patient, and I don't think Mannkind has the necessary data because they have not run any large studies since the drug was approved. A limited bridging study on PK alone is not going to be enough. It is up to the company to prove that something is true, it is not up to the FDA to disprove it. Since the default position of the FDA is that nothing is true unless proven to be true, that is a difficult negotiation posture for any company without a ton of data to back up their new claims. Cmax and AUC were dose proportional for TI but slightly sublinear for
Lispro; saturable GIRmax was obtained over the dose range for both
insulins. Onset of activity for TI occurred ca. 25-35 minutes earlier than for
Lispro. TI duration of action is about 2 hours shorter than an equivalent
dose of Lispro. Dose-response was almost linear up to 48U TI and 30 U
Lispro. www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf
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Post by mango on Aug 24, 2017 17:06:43 GMT -5
• Afrezza Pedi Clinical Trials Timeline  • Label  |
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Post by celo on Aug 24, 2017 17:16:25 GMT -5
Thanks Mango. Chart B says to me that Afrezza is meaningfully different and should get it's own designation/name.
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Post by lennymnkd on Aug 24, 2017 17:57:34 GMT -5
Matt , with All do respect ! With the current technology/ monitoring devices ... the testing would appear to be far less subjective and far more accurate than most studies / hopefully that would help expedite the process as well ... not to mention as inferd to numerous times / insulins historical medical understandings from the medical community.
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Post by itellthefuture777 on Aug 24, 2017 18:35:17 GMT -5
I imagine there will be a label change..before the trial starts..hmm
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