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Post by celo on Jun 8, 2019 10:21:28 GMT -5
Great job by Rose to announce on stock twits that Afrezza received Ultra Rapid designation in Brazil. Rose? This is major news. There is a massive population in the USA that doesn't know there is an ultra rapid product in existence, including the ADA. This should be shoved in every endo's face. There are legal things on what reps can and cannot say (I found out it's actually extremely limited and if they were to start saying ultra rapid to an endo that'd be a huge nono) and the FDA is all too eager as we've seen in the past. I'm not asking a rep to say it. I'm asking Rose to promote the fact that Afrezza got the only Ultra rapid acting insulin designation in the world to other people besides stock jockeys on ST. Unless there is another location in the world that has given the Ultra designation to an insulin medication. Lilly already has an Ultra rapid designation to a drug that is still only in phase 3 (URLi). This is definitely not for a rep to promote. It is for Mannkind to promote.
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Post by peppy on Jun 8, 2019 10:35:35 GMT -5
There are legal things on what reps can and cannot say (I found out it's actually extremely limited and if they were to start saying ultra rapid to an endo that'd be a huge nono) and the FDA is all too eager as we've seen in the past. I'm not asking a rep to say it. I'm asking Rose to promote the fact that Afrezza got the only Ultra rapid acting insulin designation in the world to other people besides stock jockeys on ST. Unless there is another location in the world that has given the Ultra designation to an insulin medication. Lilly already has an Ultra rapid designation to a drug that is still only in phase 3 (URLi).
This is definitely not for a rep to promote. It is for Mannkind to promote. Abstract URLi (LY900014), a novel ultra-rapid mealtime insulin in Phase 3 development, is shown to reduce postprandial glucose after subcutaneous injection. This study evaluated the pharmacokinetics and pharmacodynamics (PD) of URLi via CSII. In a double-blind, randomized cross-over study, 24 adult patients with T1D received URLi or insulin lispro (Humalog®; HL) for 3 days. Mixed meal tolerance tests (MMTT) were conducted on Days 1 and 3 after catheter insertion using a standard (1.5 U/min) single-wave bolus. URLi showed faster insulin lispro absorption on both days compared to HL. URLi reduced time to early half-maximal drug concentration by 37% (-8.5 min) and 32% (-5.3 min) compared to HL on Days 1 and 3 (both p<0.0001). Area under the insulin lispro concentration time curve (AUC) for the first 15 min was >50% higher than HL after dosing with URLi on Days 1 and 3 (p<0.005). URLi reduced 1-hour postprandial glucose excursion of the MMTT by 45% on Day 1 (p=NS) and 47% on Day 3 (p=0.059) compared with HL (Figure). Accelerated URLi absorption was associated with trends toward lower postprandial glucose excursion for the entire MMTT (57% and 20% reductions in ∆AUC[0-5h] on Days 1 and 3; both NS). The study was not powered for PD assessment which may contribute to the lack of statistical significance. No differences were seen in the number or severity of hypoglycemic events or local tolerability between URLi and HL. diabetes.diabetesjournals.org/content/67/Supplement_1/1006-PThe ADA does not have an ultra fast designation. One would need to be created.
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Post by nylefty on Jun 8, 2019 11:32:07 GMT -5
Rose didn't "announce" anything on StockTwits.
Somebody using the handle"GKSbay" on StockTwits posted what he or she represented as a private email response from Rose to an email question.
And where is the line between what "MannKind" can say and what its reps can say? Just asking.
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Post by celo on Jun 8, 2019 12:01:47 GMT -5
Rose didn't "announce" anything on StockTwits. Somebody using the handle"GKSbay" on StockTwits posted what he or she represented as a private email response from Rose to an email question. And where is the line between what "MannKind" can say and what its reps can say? Just asking. So you are defending the way Rose wrote an email to a stock twits guy as appropriate way to disclose how great the ultra rapid designation is? If you can email some random person then you can definitely proclaim how great this new designation is to the rest of the world. WTF!?! This is ridiculous. This is a big deal. Stop whispering it to one individual. Figure out with a few lawyers how you can shout this from the rooftops. Company is teetering on having to do another financial raise with its 1.22 stock price and Brazil just proclaimed it is the only Ultra Rapid designation in the world. Mannkind can do better. Maybe, I've got Saturday morning coming down. But I think every long term shareholder that has believed in the amazing qualities of Afrezza deserve better.
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Post by theshiv on Jun 8, 2019 12:35:19 GMT -5
An official of any entity, including MNKD executives should understand that any response via email, can and is often shared on various social media platforms. There is no expectation of privacy and the rules governing confidentiality between users within social media appear unclear as it is easy to share/re-tweet.
The inquirer could have asked Rose if it was fine to share this information. Bottom line here is if she shared that information as an officer of the company, it's news. More reason for MNKD to pump this news themselves.
Her comments in my opinion don't even fall under "views are my own," which allows some flexibility. I work with reporters and bloggers as an information officer, so I know a little about this.
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Post by letitride on Jun 8, 2019 12:52:08 GMT -5
What we need here is some Brazilian Reps working the ADA telling it the way they heard it.
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Post by nylefty on Jun 8, 2019 13:04:53 GMT -5
An official of any entity, including MNKD executives should understand that any response via email, can and is often shared on various social media platforms. There is no expectation of privacy and the rules governing confidentiality between users within social media appear unclear as it is easy to share/re-tweet. The inquirer could have asked Rose if it was fine to share this information. Bottom line here is if she shared that information as an officer of the company, it's news. More reason for MNKD to pump this news themselves. Her comments in my opinion don't even fall under "views are my own," which allows some flexibility. I work with reporters and bloggers as an information officer, so I know a little about this. The fact that Brazil had accepted the "ultra" designation was in the initial PR about the Brazilian approval. Should it have been emphasized at the time? Sure, but it's a little late now since "news" is about new developments, not old ones. I spent some 40 years in radio and TV news, so I too "know a little about this."
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Post by agedhippie on Jun 8, 2019 13:09:27 GMT -5
The cynic in me says once Lilly has URLi launched watch for an ultra rapid class popping up. It will comprise FIASP, URLi, and Affrezza. Novo and Lilly have the political clout to get that done, Mannkind alone doesn't.
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Post by slugworth008 on Jun 8, 2019 13:12:49 GMT -5
We don’t know Sherlock, maybe you could go try and find out:-)) I've zenitt all before - I couldn't help it
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Post by theshiv on Jun 8, 2019 13:44:39 GMT -5
Yes. "We all know about this," which is why we are all here. I have 40 years in radio, TV and public affairs myself and a few awards along the way for news and public affairs.
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Post by nylefty on Jun 8, 2019 13:48:50 GMT -5
Yes. "We all know about this," which is why we are all here. I have 40 years in radio, TV and public affairs myself and a few awards along the way for news and public affairs. My awards hereby challenge your awards to a duel (duels?). Twenty paces?
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Post by longliner on Jun 8, 2019 13:50:40 GMT -5
Yes. "We all know about this," which is why we are all here. I have 40 years in radio, TV and public affairs myself and a few awards along the way for news and public affairs. My awards hereby challenge your awards to a duel. Twenty paces? Monty Python came to mind
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Post by theshiv on Jun 8, 2019 13:56:19 GMT -5
As an aside, One would think that Rose as standard procedure would have vetted any comments with upper management before sharing them on any platform.
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Post by mnkdfann on Jun 8, 2019 14:05:04 GMT -5
As an aside, One would think that Rose would have vetted any comments with upper management before sharing them on any platform. YMMV, but I think it is clear by now that they do not run that tight a ship.
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Post by mytakeonit on Jun 8, 2019 14:47:34 GMT -5
Yes. "We all know about this," which is why we are all here. I have 40 years in radio, TV and public affairs myself and a few awards along the way for news and public affairs. My awards hereby challenge your awards to a duel (duels?). Twenty paces? Sounds more like a "show me yours and I'll show you mine" kinda thing. But, that's mytakeonit
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