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Post by sportsrancho on Jan 23, 2019 15:39:57 GMT -5
I would think MNKD would be hand holding these testing centers to make sure they knew what they were doing. They certainly have enough headcount and should be very aware of the fast action, thus sensitivity to time dosing properly. What a shame to even hear this type of feedback. This is unacceptable! They know exactly how to do this by now, of course you give it after the beginning of meal.
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Post by sportsrancho on Jan 23, 2019 15:42:24 GMT -5
It almost smells like they have something in their shorts. If you are implying I'm short.... you are very, very wrong. I've been in this stock since 2009 and have amassed a HUGE paper loss to date. Not something I'm proud of to say the least. I'm waiting for the turn around like everyone else.
I thought the comment on the Facebook page was worth posting, even if if made me cringe. Sorry if it wasn't a likeable post.
Thank you:-) RisingSkeptic just got caught making up a pharmacy. That may be the case here too but it’s very important information.
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Post by goyocafe on Jan 23, 2019 15:50:01 GMT -5
And some of the nurses who were dosing the kids were doing it before they walked to lunch. Read more: mnkd.proboards.com/thread/10859/update-jpm-jan-21st?page=1#ixzz5dSZMHSmiI wonder if they check backgrounds of people doing these studies to see if they have ulterior motives. Plant a couple of nurses with a bias and this is what you end up with. The notion of dosing and then delaying the meal makes no sense. MC, this is something you can and must sink your teeth into. Well, technically, isn't supposed to be administered before the meal? I doubt they would be allowed to dose it any other way. I don't recall ever reading that you are supposed to dose and then take a walk... or whatever else is being introduced into the delay between dosing and eating.
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Post by sportsrancho on Jan 23, 2019 16:16:15 GMT -5
“The research director said its moving slowly at their location. The protocols were not set up well and needed to be revamped.”
Unbelievable ..whoever that is needs to go! Are they allowed to talk about stuff like this?
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Post by travis1953 on Jan 23, 2019 16:38:33 GMT -5
Well, technically, isn't supposed to be administered before the meal? I doubt they would be allowed to dose it any other way. I don't recall ever reading that you are supposed to dose and then take a walk... or whatever else is being introduced into the delay between dosing and eating. Well, yes, but the instructions only specify to take it at the beginning of a meal. If the people conducting the study see it as similar to humalog, that could be translated as within 15 minutes of a meal.
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Post by brentie on Jan 23, 2019 16:45:36 GMT -5
I don't recall ever reading that you are supposed to dose and then take a walk... or whatever else is being introduced into the delay between dosing and eating. Well, yes, but the instructions only specify to take it at the beginning of a meal. If the people conducting the study see it as similar to humalog, that could be translated as within 15 minutes of a meal. They should have this figured out by now, this is from 2014... SF: Was that when you changed to the new device? Ai Mann: No, I think that a problem during the trials was that some patients took their dose of Afrezza even before starting to eat. The trial protocols called for Afrezza to be dosed “at the beginning of the meal,” but sometimes it was taken even before. We need to do additional trials to gain more experience with optimized dosing times. Actual ingestion of food in most meals in the United States except in restaurants takes only about 30 minutes, so I believe that the first Afrezza dose really ought to be taken ten or fifteen minutes after starting to eat. For a longer meal, which is not very common, a second dose might be taken fifty or sixty minutes after starting to eat. For a long feast that lasts for an hour and a half or more, I suggest a third dose be taken at maybe one and a half hours after start. Interestingly I believe the size of all those doses should probably be the same for most patients. Unfortunately the trial protocols called for dosing at the beginning of the meal so we will need to do more trials to be able to gain FDA label approval of optimized dosing. www.diabetesincontrol.com/an-exclusive-interview-with-al-mann-founder-and-ceo-mannkind-corp/
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Post by peppy on Jan 23, 2019 17:04:07 GMT -5
They certainly have enough headcount and should be very aware of the fast action, thus sensitivity to time dosing properly. What a shame to even hear this type of feedback. This is unacceptable! They know exactly how to do this by now, of course you give it after the beginning of meal. the schools could not perceive the difference? insulin is a nurses office thing. the schools need to rearrange their rules/administration protocol?
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Post by mnholdem on Jan 23, 2019 17:25:33 GMT -5
Pharmaceutical companies typical place one of their own doctors to coordinate and monitor clinical studies but that doesn’t guarantee that they pay close attention to what’s happening at the trial sites (ie the trial protocols are being strictly adhered to). As critical as this pediatric trial is to the future adoption of Afrezza, CMO David Kendall MD cannot ignore this rumor. He needs to check this out with MannKind’s clinical staff ASAP.
As Jerome Pettus graphically illustrated in his recent TCOYD presentation, Afrezza is nothing like injected insulin. It might be difficult for HCPs at the trial site(s) to break decades-old habits for treating diabetes.
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Post by goyocafe on Jan 23, 2019 17:37:53 GMT -5
I don't recall ever reading that you are supposed to dose and then take a walk... or whatever else is being introduced into the delay between dosing and eating. Well, yes, but the instructions only specify to take it at the beginning of a meal. If the people conducting the study see it as similar to humalog, that could be translated as within 15 minutes of a meal. Then the people executing the study have not been trained on the proper use of Afrezza. You're making the case as well as any.
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