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Post by lb on Jul 20, 2017 20:46:31 GMT -5
Weren't the new trials supposed to start between mid-June and mid-July per Matt? Why delay? Anyone?
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Post by dreamboatcruise on Jul 21, 2017 1:11:18 GMT -5
Weren't the new trials supposed to start between mid-June and mid-July per Matt? Why delay? Anyone? We know they are on a shoestring budget so that would be my first guess. MNKD is pretty tight lipped, so I assume no one knows for sure. The only other obvious thing I could think of is if trial design and approval with FDA is taking longer than anticipated.
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Post by matt on Jul 21, 2017 7:07:40 GMT -5
There is a small mountain of paperwork that must be completed before any trial gets going. That includes FDA submissions, IRB approval of the protocol and investigator's brochure, legal review by each hospital participating, third-party contracts (like insurance), engagement of a CRO for data collection and statistical analysis, organization of kick-off meetings for the participating centers, and more. In any multi-center trial, the process tends to move as slow as the slowest participant since whatever changes are made for one center winds up propagating to all centers. Given the financial difficulties that MNKD is experiencing at the moment, some participants may also be insisting on prepayment or financial performance guarantees from a third party.
The culprit for the slow down could be the sponsor (Mannkind) or any of the other participants. Combine all those reasons with the general difficulty of doing anything when key players are on summer vacation and there are plenty of opportunities for delay.
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Trials
Jul 21, 2017 7:38:06 GMT -5
Post by lennymnkd on Jul 21, 2017 7:38:06 GMT -5
Let me ask ... speaking of trials , with the pain medication epidemic :opioids / etc ... were we not on to something with the platform that bypassed the brain chemical response that these drug produce .. with the efficacy needed to do the job / seems like all we would need to get the ball rolling ... approved drugs may apply .. gigantic crisis market .. could we still be on track with this , or just not in the cards ... seems it would be a easy sell .
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Post by mnholdem on Jul 21, 2017 7:40:50 GMT -5
Michael Castagna was quoted in an interview that he considered the Afrezza pediatric trials to be the highest priority. The target date for enrollment was June 15, but they had to have missed it. The FDA requires companies to file the details of trials to be published at the ClinicalTrial.gov website no later than 21 days after the first enrollment.
Mike was right. The ped trial is HUGE and I don't understand the delay. I suspect that lack of funding is the issue. Our new CEO had better explain it at the upcoming calls when he presents his strategic plan for Afrezza and MannKind. If he doesn't, then Wall Street may view him as just another paper tiger.
As a shareholder, I expect him to communicate a viable plan in a few weeks and then to deliver results.
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Post by peppy on Jul 21, 2017 7:58:46 GMT -5
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Post by peppy on Jul 21, 2017 8:00:58 GMT -5
Trials
The date on this is 11/11/16
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Post by kball on Jul 21, 2017 9:20:20 GMT -5
There is a small mountain of paperwork that must be completed before any trial gets going. That includes FDA submissions, IRB approval of the protocol and investigator's brochure, legal review by each hospital participating, third-party contracts (like insurance), engagement of a CRO for data collection and statistical analysis, organization of kick-off meetings for the participating centers, and more. In any multi-center trial, the process tends to move as slow as the slowest participant since whatever changes are made for one center winds up propagating to all centers. Given the financial difficulties that MNKD is experiencing at the moment, some participants may also be insisting on prepayment or financial performance guarantees from a third party. The culprit for the slow down could be the sponsor (Mannkind) or any of the other participants. Combine all those reasons with the general difficulty of doing anything when key players are on summer vacation and there are plenty of opportunities for delay. Every single one of these well written, informative posts i read from this guy makes me feel like the rest of us are all just piling in a van on the way to little league practice, while Matt is the lone adult driving. Damn Matt. Now who wants to go for ice cream?
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Post by saxcmann on Jul 21, 2017 9:25:16 GMT -5
There is a small mountain of paperwork that must be completed before any trial gets going. That includes FDA submissions, IRB approval of the protocol and investigator's brochure, legal review by each hospital participating, third-party contracts (like insurance), engagement of a CRO for data collection and statistical analysis, organization of kick-off meetings for the participating centers, and more. In any multi-center trial, the process tends to move as slow as the slowest participant since whatever changes are made for one center winds up propagating to all centers. Given the financial difficulties that MNKD is experiencing at the moment, some participants may also be insisting on prepayment or financial performance guarantees from a third party. The culprit for the slow down could be the sponsor (Mannkind) or any of the other participants. Combine all those reasons with the general difficulty of doing anything when key players are on summer vacation and there are plenty of opportunities for delay. Every single one of these well written, informative posts i read from this guy makes me feel like the rest of us are all just piling in a van on the way to little league practice, while Matt is the lone adult driving. Damn Matt. Now who wants to go for ice cream? Now that's funny! Maybe nap time after ice cream?
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Post by mango on Jul 21, 2017 9:35:26 GMT -5
There is a small mountain of paperwork that must be completed before any trial gets going. That includes FDA submissions, IRB approval of the protocol and investigator's brochure, legal review by each hospital participating, third-party contracts (like insurance), engagement of a CRO for data collection and statistical analysis, organization of kick-off meetings for the participating centers, and more. In any multi-center trial, the process tends to move as slow as the slowest participant since whatever changes are made for one center winds up propagating to all centers. Given the financial difficulties that MNKD is experiencing at the moment, some participants may also be insisting on prepayment or financial performance guarantees from a third party. The culprit for the slow down could be the sponsor (Mannkind) or any of the other participants. Combine all those reasons with the general difficulty of doing anything when key players are on summer vacation and there are plenty of opportunities for delay. MannKind is not the Sponsor. MannKind is one of four Collaborators. Sponsor:University of Colorado Denver School of Medicine Barbara Davis Center Collaborators:Atlanta Diabetes Associates University of Southern California Rainier Clinical Research Center Mannkind Corporation
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Post by lennymnkd on Jul 21, 2017 11:46:32 GMT -5
So much for that one I guess ?
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Trials
Jul 21, 2017 15:29:18 GMT -5
Post by thall on Jul 21, 2017 15:29:18 GMT -5
There is a small mountain of paperwork that must be completed before any trial gets going. That includes FDA submissions, IRB approval of the protocol and investigator's brochure, legal review by each hospital participating, third-party contracts (like insurance), engagement of a CRO for data collection and statistical analysis, organization of kick-off meetings for the participating centers, and more. In any multi-center trial, the process tends to move as slow as the slowest participant since whatever changes are made for one center winds up propagating to all centers. Given the financial difficulties that MNKD is experiencing at the moment, some participants may also be insisting on prepayment or financial performance guarantees from a third party. The culprit for the slow down could be the sponsor (Mannkind) or any of the other participants. Combine all those reasons with the general difficulty of doing anything when key players are on summer vacation and there are plenty of opportunities for delay. As I understand it, the pediatrics trial is just a phase 1 PK and safety study that requires only around 30 patients and a couple of months to do. Sanofi had one up and running by October, 2015, and had even done some patients but pulled out. MNKD couldn't have just assumed responsibilty of that study? Or offered to pay Sanofi to complete the study for them? Or just used the already approved protocol of that study?
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Post by falconquest on Jul 21, 2017 17:17:10 GMT -5
Mannkind management for years has created false expectations they cannot live up to. Probably the worst (or best example, depending on your perspective) is the "embarrassment of riches" comment by Matt about the future potential of Technosphere applications. Quite frankly, they need to respectfully, keep their mouth shut until they know something is actually going to happen rather than opine about potential events. These unrealistic comments serve nothing but to establish false expectations among investors.
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Trials
Jul 21, 2017 17:53:27 GMT -5
via mobile
Post by bioexec25 on Jul 21, 2017 17:53:27 GMT -5
There is a small mountain of paperwork that must be completed before any trial gets going. That includes FDA submissions, IRB approval of the protocol and investigator's brochure, legal review by each hospital participating, third-party contracts (like insurance), engagement of a CRO for data collection and statistical analysis, organization of kick-off meetings for the participating centers, and more. In any multi-center trial, the process tends to move as slow as the slowest participant since whatever changes are made for one center winds up propagating to all centers ............ Every single one of these well written, informative posts i read from this guy makes me feel like the rest of us are all just piling in a van on the way to little league practice, while Matt is the lone adult driving. Damn Matt. Now who wants to go for ice cream? Kball, I used to think we collectively had a bit too much groupthink but perhaps it's the antithesis. Perhaps it's Abilene Paradox. The ice cream run notwithstanding. :-)) en.m.wikipedia.org/wiki/Abilene_paradox
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Post by falconquest on Jul 21, 2017 18:35:46 GMT -5
Kball, I used to think we collectively had a bit too much groupthink but perhaps it's the antithesis. Perhaps it's Abilene Paradox. The ice cream run notwithstanding. :-)) en.m.wikipedia.org/wiki/Abilene_paradoxWait, does this mean we don't get ice cream?
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