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Post by Deleted on Mar 8, 2017 10:33:17 GMT -5
I thought pediatric trial required less than 50 participants?
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Post by goyocafe on Mar 8, 2017 10:35:53 GMT -5
You left out pediatric trials seem to have taken a back seat to the back seat. Never ceases to amaze me, too. Do you know how much a clinical trial costs?? Much as we need it, funding a trial right now detracts from the one immediate goal of selling more product. I don't know. But I look at the news it would generate once approved for kids, the uptake by organizations like JDRF, and additional prescribing pool (pediatric docs), as a huge potential for increased sales. Without numbers for all of it, we're all guessing, but it's long overdue (IMO).
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Post by derek2 on Mar 8, 2017 10:42:54 GMT -5
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Post by brentie on Mar 8, 2017 10:51:34 GMT -5
Does anybody know if they've even done the Phase 1 pediatric study that Matt referred to here? "Clearly, we’ll be responsible for taking over the costs of those trials. The costs are relatively low at this point. The pediatric study is – it’s a small first phase of a larger study, so at least in 2016 – I don’t know if Ray wants to say anymore about it, the costs are not going to be terribly great." seekingalpha.com/article/3862956-mannkinds-mnkd-investor-conference-call-transcript
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Post by sla55 on Mar 8, 2017 11:08:16 GMT -5
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Post by brentie on Mar 8, 2017 11:17:41 GMT -5
Thanks, sla. I'm glad to hear that. Otherwise, this trial could have gone on forever.
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Post by dreamboatcruise on Mar 8, 2017 13:03:37 GMT -5
Yes nobody knows what to do. Sanofi didn't know what to do and we are now on what Mannkind 3.0? Our best strategy to date is the titration pack which is great but to me it feels like "hey here are a bunch of different options give it a go and see what works!" Doctors will not prescribe and PWD will not pay the money to experiment like that. Nobody is saying the drug isn't incredible or not a life changer but 2 years later and well the numbers speak for themselves. Sanofi knew exactly what to do. They got $250M and started a new company with Google. Their plan is to go after the PCP T2 market. The question is how? What their plan? They are not going after the endos. What's the Edelman protocol? From coverage I've seen of Onduo it seems as if the cooperation with TCOYD (Edelman) isn't the central focus of Onduo. Which sources of information are you drawing upon to conclude that Onduo is going to be centered around an "Edelman protocol"? One source I found says TCOYD was solicited for input on "future product designs"... implying they had little or no input into what is viewed as the first products of Onduo. Also, it seemed Sanofi was being positioned as providing the expertise in therapeutics. It's nice that Edelman's organization is assoicated with Onduo, and that he's been a supporter of Afrezza, but given that SNY has put in $250M and is clearly anti-Afrezza now, I'm guessing Onduo isn't going to be making it look like SNY were a bunch of idiots or heartless schemers in picking up and then leaving for dead MNKD.
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Post by gamblerjag on Mar 8, 2017 13:11:07 GMT -5
well surprisingly with the new recent highs of 12% gains in the major indicies since November.. there were more 52 week lows than highs the last two weeks. That is suprising to me. At least MNKD isn't alone!!
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Post by agedhippie on Mar 8, 2017 13:45:47 GMT -5
Sanofi knew exactly what to do. They got $250M and started a new company with Google. Their plan is to go after the PCP T2 market. The question is how? What their plan? They are not going after the endos. What's the Edelman protocol? From coverage I've seen of Onduo it seems as if the cooperation with TCOYD (Edelman) isn't the central focus of Onduo. Which sources of information are you drawing upon to conclude that Onduo is going to be centered around an "Edelman protocol"? One source I found says TCOYD was solicited for input on "future product designs"... implying they had little or no input into what is viewed as the first products of Onduo. Also, it seemed Sanofi was being positioned as providing the expertise in therapeutics. It's nice that Edelman's organization is assoicated with Onduo, and that he's been a supporter of Afrezza, but given that SNY has put in $250M and is clearly anti-Afrezza now, I'm guessing Onduo isn't going to be making it look like SNY were a bunch of idiots or heartless schemers in picking up and then leaving for dead MNKD. Well put. I had given up arguing the point. Onduo has to be insulin agnostic, actually treatment agnostic, because it's about using data for better outcomes. People persist in thinking that it is somehow going to drive drug sales. Onduo is focused on connected devices, not what the devices are dispensing. As a case in point there is a lot of work going on at the moment around basal + GLP-1 rather than basal + prandial insulin (I don't think this pans out at the advanced end but it does loot good at the early end.)
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Post by dreamboatcruise on Mar 8, 2017 14:00:39 GMT -5
From coverage I've seen of Onduo it seems as if the cooperation with TCOYD (Edelman) isn't the central focus of Onduo. Which sources of information are you drawing upon to conclude that Onduo is going to be centered around an "Edelman protocol"? One source I found says TCOYD was solicited for input on "future product designs"... implying they had little or no input into what is viewed as the first products of Onduo. Also, it seemed Sanofi was being positioned as providing the expertise in therapeutics. It's nice that Edelman's organization is assoicated with Onduo, and that he's been a supporter of Afrezza, but given that SNY has put in $250M and is clearly anti-Afrezza now, I'm guessing Onduo isn't going to be making it look like SNY were a bunch of idiots or heartless schemers in picking up and then leaving for dead MNKD. Well put. I had given up arguing the point. Onduo has to be insulin agnostic, actually treatment agnostic, because it's about using data for better outcomes. People persist in thinking that it is somehow going to drive drug sales. Onduo is focused on connected devices, not what the devices are dispensing. As a case in point there is a lot of work going on at the moment around basal + GLP-1 rather than basal + prandial insulin (I don't think this pans out at the advanced end but it does loot good at the early end.) Too bad MNKD doesn't have enough money to have an inhaled basal + GLP-1 in the works... assuming this combination is widely adopted. Though I guess basal insulin would be hard if direct into blood through lungs. But at one point GLP-1 was a target for MNKD, which now seems off the table for a long while.
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Post by mnholdem on Mar 8, 2017 14:37:21 GMT -5
The original trial document stated 47 patients. clinicaltrials.gov/archive/NCT02527265/2015_08_17
Excerpt:
Descriptive Information Brief title
Afrezza Safety and Pharmacokinetics Study in Pediatric Patients Official title
Open-label, Single-arm, Multiple-dose Safety, Titration, and Pharmacokinetic Trial of Afrezza® in Pediatric Patients Ages 4 to 17 Years With Type 1 Diabetes Mellitus
Brief summary
Primary Objective: -To assess the safety and tolerability of Afrezza in children ages 4 to 17 years with type 1 diabetes mellitus (T1DM).
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.
Detailed description
The patients are expected to participate in the study for approximately 6 to 8 weeks from Screening to final follow-up visit. Patients who completed 4 weeks of Afrezza treatment and have shown to be safe and well controlled with Afrezza + basal insulin will have the option to continue the extension treatment up to 1 year. Enrollment 46 (Anticipated)
Condition Type 1 Diabetes Mellitus Arm/Group Arm Label: SAR439065 Experimental
Individualized dose of SAR439065 for each patient at each meal (breakfast, lunch, and dinner) for 30 days, with an optional extension up to a year. During the trial, all patients will receive multiple injections of basal long acting insulin, in general at bedtime every day. Intervention
Drug: Insulin human SAR439065 Arm Label: SAR439065 Pharmaceutical form:powder Route of administration: inhalation
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Post by brentie on Mar 8, 2017 15:31:49 GMT -5
That must be the Phase 1 trial I asked about earlier.
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Post by Deleted on Mar 8, 2017 15:40:18 GMT -5
thanks mnholdem thats where I remember under 50 from. for each participant, it should require 15k to 20K - so a million? But the damn protocol is being worked for ever.
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Post by buyitonsale on Mar 8, 2017 15:52:03 GMT -5
At JPM conference in January MNKD said pediatric trials are expected to start this year. JDRF partnership should mean something, no?
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Post by lennymnkd on Mar 8, 2017 16:02:03 GMT -5
As far as ondou is concerned , glad I'm not in business with you guys / your telling me some type of deal could not become a reality aside from the data portion of their "project" ... it's not like we're building jet engines.. we have a products with synergies of the GLM that could not be more perfect / I ENVISION: television ads run in a joint advertising venture with the likes of a Dexcom 5 , or whomever CGM... monitor/ look at watch ... inhale and (. The rest is up to you : sports, food , work, beach , etc :BEST PART SPLIT ADVERTISING COST .. mike Lenny says get on it !
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