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Post by rfogel on Nov 7, 2019 10:47:54 GMT -5
Per the transcript, the CEO said: "The next part will be running here in a few weeks will be the human factor study. Mankind is running that based on our history of our [dreamboat] device. Our team is fully capable of doing a study. I don't expect a lot of risk."
He appears to be referring to TreT. What is a "human factor study"? Why is Mannkind doing it? Is it necessary for TreT FDA approval?
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Post by mnkdfann on Nov 7, 2019 11:28:40 GMT -5
Per the transcript, the CEO said: "The next part will be running here in a few weeks will be the human factor study. Mankind is running that based on our history of our [dreamboat] device. Our team is fully capable of doing a study. I don't expect a lot of risk." He appears to be referring to TreT. What is a " human factor study"? Why is Mannkind doing it? Is it necessary for TreT FDA approval? As a start, just google the words: human factor study fda. Here's one hit from the FDA: www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/human-factors-and-medical-devices |
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Post by rfogel on Nov 7, 2019 12:05:48 GMT -5
Okay, but why is it being done? The dreamboat has been around for years now with no human factors study that I could find. And if it is necessary to TreT, why isn't United Therapeutics doing it?
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Post by od on Nov 7, 2019 12:28:14 GMT -5
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Post by rfogel on Nov 7, 2019 13:20:14 GMT -5
Okay, so it appears they did one back in 2012 for the dreamboat. Why is another required now? Are they using a different design? And again, if it has to do with TreT, why isn't United handling it?
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sky
Lab Rat
Posts: 46 
Sentiment: Long
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Post by sky on Nov 7, 2019 13:41:15 GMT -5
Okay, so it appears they did one back in 2012 for the dreamboat. Why is another required now? Are they using a different design? And again, if it has to do with TreT, why isn't United handling it? Maybe the Blue hail ? |
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Post by rfogel on Nov 7, 2019 15:58:05 GMT -5
Okay, so it appears they did one back in 2012 for the dreamboat. Why is another required now? Are they using a different design? And again, if it has to do with TreT, why isn't United handling it? Maybe the Blue hail ? Good point, although I thought of that as more of a teaching tool than a true medical device. But that brings up another question, if it is a medical device do they have to follow any sort of approval procedure beyond a human factors study in order to market it? |
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Post by peppy on Nov 7, 2019 16:06:28 GMT -5
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Post by slugworth008 on Nov 7, 2019 16:53:34 GMT -5
Per the transcript, the CEO said: "The next part will be running here in a few weeks will be the human factor study. Mankind is running that based on our history of our [dreamboat] device. Our team is fully capable of doing a study. I don't expect a lot of risk." He appears to be referring to TreT. What is a "human factor study"? Why is Mannkind doing it? Is it necessary for TreT FDA approval? WOuldn't it have been nice if that was clarified on the call? Oh - just more MNKD BS |
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Post by sayhey24 on Nov 7, 2019 19:22:31 GMT -5
What is a "human factor study"? Why is Mannkind doing it? The HFS is where they give study participants the inhaler and cartridge and have them put the cartridge in the inhaler and then suck on it. Back in the day this is where BluHale was developed to see how hard people were sucking and how much powder was left the inhaler. The also kept track of how many people knew how to use the inhaler with little instruction. For example using it upside down. When afrezza was introduced 5 years ago DiabetesMine was a pretty big online publication and one of the writers was an initial afrezza user who swore afrezza was junk and did not work. The bashers loved her back then. After looking at a picture she published online it became clear she had the inhaler upside down. After flipping the inhaler right side up she became a big proponent - www.slideshare.net/amytenderich/mannkind-afrezza-bluhale-data-tool-demo-at-the-june-2019-diabetesmine-ddata-exchangeWhy is Mannkind doing it? First, MNKD is getting paid to do it. So while it may not be a great deal of revenue beggars can't be choosers. Additionally, as Mike said MNKD has a lot of experience in doing this for afrezza and I suspect they developed another BluHale device to fit the form factor of the TretT inhaler. |
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Post by peppy on Nov 7, 2019 19:35:39 GMT -5
What is a " human factor study"? Why is Mannkind doing it? The HFS is where they give study participants the inhaler and cartridge and have them put the cartridge in the inhaler and then suck on it. Back in the day this is where BluHale was developed to see how hard people were sucking and how much powder was left the inhaler. The also kept track of how many people knew how to use the inhaler with little instruction. For example using it upside down. When afrezza was introduced 5 years ago DiabetesMine was a pretty big online publication and one of the writers was an initial afrezza user who swore afrezza was junk and did not work. The bashers loved her back then. After looking at a picture she published online it became clear she had the inhaler upside down. After flipping the inhaler right side up she became a big proponent - www.slideshare.net/amytenderich/mannkind-afrezza-bluhale-data-tool-demo-at-the-june-2019-diabetesmine-ddata-exchangeWhy is Mannkind doing it? First, MNKD is getting paid to do it. So while it may not be a great deal of revenue beggars can't be choosers. Additionally, as Mike said MNKD has a lot of experience in doing this for afrezza and I suspect they developed another BluHale device to fit the form factor of the TretT inhaler.Pulmonary hypertension symptoms include: Shortness of breath (dyspnea), initially while exercising and eventually while at rest. Fatigue. Dizziness or fainting spells (syncope) Chest pressure or pain. Swelling (edema) in your ankles, legs and eventually in your abdomen (ascites) |
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Post by mytakeonit on Nov 7, 2019 20:12:53 GMT -5
Okay, I only have a few of those symptoms ... so, it must be the wine.
But, that's mytakeonit
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