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Post by longstocking on Aug 19, 2015 19:12:56 GMT -5
One would think a 2 unit cartridge will be necessary for the pediatric trial. If true, except an announcement next month. MNKD has a small batch line that they used for previous studies. They could dedicate this to producing 2-unit cartridges for the study without tying up any of the regular production lines. Didn't know that. Thanks for the info. |
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Post by BlueCat on Aug 21, 2015 2:18:42 GMT -5
Godspeed, MNKD.
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Post by Deleted on Mar 15, 2016 10:38:23 GMT -5
The study has suspended recruiting . Is the study filled or will resume recruiting after the NDA transfer? It was only 46 patients
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Post by peppy on Mar 15, 2016 10:42:15 GMT -5
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Post by mnholdem on Mar 15, 2016 10:43:24 GMT -5
The study has suspended recruiting . Is the study filled or will resume recruiting after the NDA transfer? It was only 46 patients
This study has suspended participant recruitment.
(Due to transfer of ownership of Afrezza IND & NDA back to MannKind Corporation, enrollment into the TDR14323 study was suspended)
Source: clinicaltrials.gov/ct2/show/NCT02527265?term=SAR439065&rank=2
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Post by 4allthemarbles on Mar 15, 2016 10:57:55 GMT -5
What a shock...
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Post by mnholdem on Mar 15, 2016 11:25:51 GMT -5
Part I of the pediatric trial is cheap. Matt mentioned that at his last conference. I was delighted that he didn't bother repeating it to an analyst who cannot/will not remember information that has been previously supplied.
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Post by mindovermatter on Mar 15, 2016 11:28:29 GMT -5
I don't see this as a problem. Recruitment has halted but not the study itself. Huge difference.
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Post by mnholdem on Mar 15, 2016 11:37:17 GMT -5
Agreed. This is a non-issue, but this is one study that MannKind absolutely does NOT want to delay any longer than necessary.
Being able to prescribe Afrezza to kids? Cha-Ching!
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Post by seanismorris on Jun 20, 2016 18:34:58 GMT -5
For anyone interested, especially those that dislike my negativity...
Restarting the pediatric trial would go a long way to restoring some of my confidence in MannKind. Especially, if Matt said we'd have data to display by the end of the year.
It's been 3 months...it's past time for the restart.
FYI: I was very high on the pediatric trial data for use convincing Docs of the safely and effectiveness of Afrezza.
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Post by Deleted on Jun 20, 2016 19:32:44 GMT -5
For anyone interested, especially those that dislike my negativity... Restarting the pediatric trial would go a long way to restoring some of my confidence in MannKind. Especially, if Matt said we'd have data to display by the end of the year. It's been 3 months...it's past time for the restart. FYI: I was very high on the pediatric trial data for use convincing Docs of the safely and effectiveness of Afrezza. trial protocol in q3. so may be recruiting in q4 and partial trial data may take 30 to 60 days? below is from sanofi trial which is suspended now... Primary Outcome Measures:
Number of patients with adverse events [ Time Frame: up to 1 week after last treatment ] [ Designated as safety issue: Yes ]
Number of patients with hypoglycemic events [ Time Frame: up to 1 week after last treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
insulin maximum observed concentration (Cmax) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
insulin time to reach Cmax (tmax) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
insulin area under concentration time curve (AUC) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
insulin apparent clearance (CL/F) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
insulin apparent volume of distribution (Vss/F) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Assessment of fumaryl diketopiperazine (FDKP) elimination half-life (t1/2) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Number of patients adhered to dose titration rules [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Number of patients completed the scheduled treatment period [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Assessment of patient's ability to use Afrezza inhalation device [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Measurement of anti-insulin antibodies [ Time Frame: Up to 13 months ] [ Designated as safety issue: Yes ] |
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Post by peppy on Jun 20, 2016 19:55:04 GMT -5
For anyone interested, especially those that dislike my negativity... Restarting the pediatric trial would go a long way to restoring some of my confidence in MannKind. Especially, if Matt said we'd have data to display by the end of the year. It's been 3 months...it's past time for the restart. FYI: I was very high on the pediatric trial data for use convincing Docs of the safely and effectiveness of Afrezza. trial protocol in q3. so may be recruiting in q4 and partial trial data may take 30 to 60 days? below is from sanofi trial which is suspended now... Primary Outcome Measures:
Number of patients with adverse events [ Time Frame: up to 1 week after last treatment ] [ Designated as safety issue: Yes ]
Number of patients with hypoglycemic events [ Time Frame: up to 1 week after last treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
insulin maximum observed concentration (Cmax) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
insulin time to reach Cmax (tmax) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
insulin area under concentration time curve (AUC) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
insulin apparent clearance (CL/F) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
insulin apparent volume of distribution (Vss/F) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Assessment of fumaryl diketopiperazine (FDKP) elimination half-life (t1/2) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Number of patients adhered to dose titration rules [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Number of patients completed the scheduled treatment period [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Assessment of patient's ability to use Afrezza inhalation device [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Measurement of anti-insulin antibodies [ Time Frame: Up to 13 months ] [ Designated as safety issue: Yes ]seeker, is this the newly stated time frame? trial protocol in q3. so may be recruiting in q4 and partial trial data may take 30 to 60 days?
Sanofi had the trial listed as recruiting for months before the cancel. Pep
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Post by Deleted on Jun 20, 2016 20:26:15 GMT -5
trial protocol in q3. so may be recruiting in q4 and partial trial data may take 30 to 60 days? seeker, is this the newly stated time frame? trial protocol in q3. so may be recruiting in q4 and partial trial data may take 30 to 60 days?
Sanofi had the trial listed as recruiting for months before the cancel. Pep
should have put a disclaimer - thats its my guess as it was stated that the pediatric trials will be designed to suit other countries and so the urgency. as with Sanofi recruiting 4 ever, I would expect no less from such a big company. With mannkind, it could be sooner and the earlier participants can move to the new trial? thats how I would do it if it was upto me.. but you never kno |
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