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Post by celo on Oct 12, 2017 16:38:51 GMT -5
Thank you what a great video to listen to. I cannot believe he said hes announcing a partnership for Brazil in 2 weeks. I haven't really looked at the message board yet but am I the only one who's unbelievably excited about this? Today's comments by Mike C. Re:Brazil on Biz Radio, "Were on the cusp of announcing, ahh.. we did a partnership in Brazil and that should be filing within the next week or two as well, so we are excited about that"They already announced they are going to work with Biomm in Brazil back in May, and that Biomm would be preparing and filing in Brazil for Approval, so it sounds like Biomm is Filing the application within the next week or two. investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=1028526
MannKind and Biomm Enter Into Distribution Agreement for Afrezza in Brazil
VALENCIA, Calif. and BELO HORIZONTE, Brazil, May 31, 2017 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) and BIOMM SA (BVMF:BIOM3) today announced that they have entered into a supply and distribution agreement for the commercialization of Afrezza® (insulin human) Inhalation Powder in Brazil. Under the supply and distribution agreement, Biomm will be responsible for preparing and filing the necessary applications for regulatory approval of Afrezza, including from the Agência Nacional de Vigilância Sanitária and, with respect to pricing matters, from the Camara de Regulação de Mercado de Medicamentos. Upon satisfactory approval from these regulatory bodies, MannKind will manufacture and supply Afrezza to Biomm, and Biomm will be responsible for promoting and distributing Afrezza within Brazil. The filing for approval in Brazil will happen in the next week or two. Anybody have an idea of the length of the approval process in Brazil? I'm just trying to understand how long until sales can occur in Brazil. |
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Post by peppy on Oct 12, 2017 16:48:41 GMT -5
hard to say? Afrezza is human insulin. dmsjournal.biomedcentral.com/articles/10.1186/s13098-016-0150-8Abstract Background In 2011, private pharmacies associated to the Brazilian Ministry of Health provided patients with two types of insulin (regular human insulin and isophane insulin or NPH) and three oral antidiabetic medications (5 mg glibenclamide and 500 and 850 mg metformin) free of charge. The aim was to evaluate the impact of the “Health Has No Price” Program [Saúde Não Tem Preço (SNTP)] for access to diabetes treatment medicines in Brazil. |
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Post by kc on Oct 12, 2017 17:33:00 GMT -5
Consider this, Mike C was probably given 20 or 30 minutes to summarize a 27 year story, and I’d be willing to bet he did it for the most part, “freestyle” or unrehearsed. Its very difficult to decide what gets cut out and what gets attention, and for the most part, anything that does make the cut is only briefly covered. I thought he knocked it out of the park, and as time goes on, and these guest appearances happen more often, he will only get better. Imagine that, our CEO making a guest appearance on live SiriusXM Radio. 👏🏻👏🏻👏🏻👏🏻👏🏻👏🏻👏🏻💯🔝🔝🔝🎯 Agreed - my nitpick was about his need to project his voice more, not a criticism of what he said. It was a phone conversation on a Cell phone. He did just great. Now the question is what size audience was listening to it on Biz Radio. I had seen in on my XM for many years but frankly had not ever listened to it. My xm is always tuned to either Fox News (yah I know) or CNBC in the AM from 6:30 am to 9:00 AM. or to Classic rock (showing my age). |
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Post by kc on Oct 12, 2017 17:36:36 GMT -5
LFD just came out with another hit piece at exactly 4:02 pm on SA with a disgusting header too. You can't tell me that phony writer isn't with BP, nor is he not embedded somewhere here too. I'm so tired of that trash talk. Someday, he will be gone forever and crawl back to the hole he slithered out of! Btw, I did not read that trash piece, just saw the header and "author" which was enough for me. I stopped reading his garbage several years back. I rarely reply to SA and especially LFD. But had to with this one. (LFD title: MannKind: The State Of Denmark Isn't The Only Place Something Is Rotten)
LFD you finally got something right! There is something ROTTON IN DENMARK........
its at the Headquarters of:
Novo Nordisk A/S, Headquarters
Contact info
Head of Office: Mr Lars Fruergaard Jørgensen
He has a delivery problem as his products rely on using icky Needles and old school methods of treating diabetes. He should really investigate a new technology that has a patented method of delivery of Insulin its available from a company named MannKind.
But then again Writers like LFD have pronounced MannKind dead and buried with no pulse. So maybe the folks in Denmark are not aware of Afrezza and how easy it is to use. What immediate action it has for helping a Diabetic gain blood Glucose control. That it also has long term benefits as it reduces A1C. Funny, how this little pimple of a company can cause panic in the world of injected insulin companies.
I am glad your not invested as most of MannKind's investors while current bag holders are hopeful that one day if the company survives that it will make the lives of diabetics easier and more compliant towards good health and reduced complications that will = a longer life to enjoy.
The CEO of MannKind Mike Castagna is a very motivational person and seems the company heading in a better direction. Listen to some of his comments today on a radio show on the Biz Radio network.
bit.ly/2ydCo4a
Perhaps his Technosphere is filled with a new product called MannKind confidence.
For the Record I am a long term MannKind investor.
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Post by patten1962 on Oct 12, 2017 17:44:05 GMT -5
Thank you what a great video to listen to. I cannot believe he said hes announcing a partnership for Brazil in 2 weeks. I haven't really looked at the message board yet but am I the only one who's unbelievably excited about this? Today's comments by Mike C. Re:Brazil on Biz Radio, "Were on the cusp of announcing, ahh.. we did a partnership in Brazil and that should be filing within the next week or two as well, so we are excited about that"They already announced they are going to work with Biomm in Brazil back in May, and that Biomm would be preparing and filing in Brazil for Approval, so it sounds like Biomm is Filing the application within the next week or two. investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=1028526
MannKind and Biomm Enter Into Distribution Agreement for Afrezza in Brazil
VALENCIA, Calif. and BELO HORIZONTE, Brazil, May 31, 2017 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) and BIOMM SA (BVMF:BIOM3) today announced that they have entered into a supply and distribution agreement for the commercialization of Afrezza® (insulin human) Inhalation Powder in Brazil. Under the supply and distribution agreement, Biomm will be responsible for preparing and filing the necessary applications for regulatory approval of Afrezza, including from the Agência Nacional de Vigilância Sanitária and, with respect to pricing matters, from the Camara de Regulação de Mercado de Medicamentos. Upon satisfactory approval from these regulatory bodies, MannKind will manufacture and supply Afrezza to Biomm, and Biomm will be responsible for promoting and distributing Afrezza within Brazil. So maybe I misunderstood a little bit. I did know that was announced. What I took from the call, I was hoping Mike in 2 weeks would be talking in detail about what this partnership would bring to mankind? Is this company going to give us up front money? Does anyone on this board have any idea of what a partnership like this may bring? |
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Post by Omega on Oct 12, 2017 18:12:22 GMT -5
Today's comments by Mike C. Re:Brazil on Biz Radio, "Were on the cusp of announcing, ahh.. we did a partnership in Brazil and that should be filing within the next week or two as well, so we are excited about that"They already announced they are going to work with Biomm in Brazil back in May, and that Biomm would be preparing and filing in Brazil for Approval, so it sounds like Biomm is Filing the application within the next week or two. investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=1028526
MannKind and Biomm Enter Into Distribution Agreement for Afrezza in Brazil
VALENCIA, Calif. and BELO HORIZONTE, Brazil, May 31, 2017 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) and BIOMM SA (BVMF:BIOM3) today announced that they have entered into a supply and distribution agreement for the commercialization of Afrezza® (insulin human) Inhalation Powder in Brazil. Under the supply and distribution agreement, Biomm will be responsible for preparing and filing the necessary applications for regulatory approval of Afrezza, including from the Agência Nacional de Vigilância Sanitária and, with respect to pricing matters, from the Camara de Regulação de Mercado de Medicamentos. Upon satisfactory approval from these regulatory bodies, MannKind will manufacture and supply Afrezza to Biomm, and Biomm will be responsible for promoting and distributing Afrezza within Brazil. The filing for approval in Brazil will happen in the next week or two. Anybody have an idea of the length of the approval process in Brazil? I'm just trying to understand how long until sales can occur in Brazil. I found this while looking for an Approval Timeline for Brazil: Brazil to Expedite Review and Approval Process, Recognize Foreign Audits and Inspections raps.org/focus-online/news/news-article-view/article/3072/<snip> Another goal is to reduce the time it takes the agency to review and approve applications from nine months on average to six months for technological innovation and priority medications for hypertension, diabetes and cancer. The reduction to six months would be consistent with the review time of other agencies such as the US Food and Drug Administration (FDA).
Among the other proposals announced is one allowing Anvisa to recognize audits and inspections carried out by other international agencies and accreditation bodies. </snip> |
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Post by mnkdnewbie on Oct 12, 2017 18:18:52 GMT -5
I was hoping he used up the whole atm around $6, but for some reason in my gut he only did 10 million shares from the atm because he is saving the others for when he announces the Brazil partnership and other news and thinks pps will be higher...obviously whoverever bought the first 10 million thinks it's worth more than $6....
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Post by patten1962 on Oct 12, 2017 18:19:38 GMT -5
The filing for approval in Brazil will happen in the next week or two. Anybody have an idea of the length of the approval process in Brazil? I'm just trying to understand how long until sales can occur in Brazil. I found this while looking for an Approval Timeline for Brazil: Brazil to Expedite Review and Approval Process, Recognize Foreign Audits and Inspections raps.org/focus-online/news/news-article-view/article/3072/<snip> Another goal is to reduce the time it takes the agency to review and approve applications from nine months on average to six months for technological innovation and priority medications for hypertension, diabetes and cancer. The reduction to six months would be consistent with the review time of other agencies such as the US Food and Drug Administration (FDA).
Among the other proposals announced is one allowing Anvisa to recognize audits and inspections carried out by other international agencies and accreditation bodies. </snip> I don't understand things as well as some of you guys But I thought mannkind had already filed paperwork in Brazil before the partnership was announced a few months back. I thought this happened when Matt was still CEO. Can someone clarify that for me. |
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Post by sayhey24 on Oct 12, 2017 19:30:43 GMT -5
Today's comments by Mike C. Re:Brazil on Biz Radio, "Were on the cusp of announcing, ahh.. we did a partnership in Brazil and that should be filing within the next week or two as well, so we are excited about that"They already announced they are going to work with Biomm in Brazil back in May, and that Biomm would be preparing and filing in Brazil for Approval, so it sounds like Biomm is Filing the application within the next week or two. investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=1028526
MannKind and Biomm Enter Into Distribution Agreement for Afrezza in Brazil
VALENCIA, Calif. and BELO HORIZONTE, Brazil, May 31, 2017 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) and BIOMM SA (BVMF:BIOM3) today announced that they have entered into a supply and distribution agreement for the commercialization of Afrezza® (insulin human) Inhalation Powder in Brazil. Under the supply and distribution agreement, Biomm will be responsible for preparing and filing the necessary applications for regulatory approval of Afrezza, including from the Agência Nacional de Vigilância Sanitária and, with respect to pricing matters, from the Camara de Regulação de Mercado de Medicamentos. Upon satisfactory approval from these regulatory bodies, MannKind will manufacture and supply Afrezza to Biomm, and Biomm will be responsible for promoting and distributing Afrezza within Brazil. So maybe I misunderstood a little bit. I did know that was announced. What I took from the call, I was hoping Mike in 2 weeks would be talking in detail about what this partnership would bring to mankind? Is this company going to give us up front money? Does anyone on this board have any idea of what a partnership like this may bring? In the past they said they are signing distributors. Today Mike said partnership but he also stumbled and stopped what he was going to say "Were on the cusp of announcing, ahh.." I am not sure which direction they are going. Of course things could change but distributors purchase the goods they sell and resell it. They have well defined territories. In my personal experience I never cared what my distributors did with my product as long as they met their contractual quotas and paid the invoice. For all I cared they could have taken all the product and thrown it in the trash. For sure one thing we did was push product on the distributors so they would exceed quotas and make bonus. We will need to wait for the details of the exact model MNKD is following and how good a negotiator Mike is. Right now, IMO between the new label and the $60M Mike is holding an ace high flush. We should not have to wait much longer for the answer. |
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Post by patten1962 on Oct 12, 2017 19:36:28 GMT -5
So maybe I misunderstood a little bit. I did know that was announced. What I took from the call, I was hoping Mike in 2 weeks would be talking in detail about what this partnership would bring to mankind? Is this company going to give us up front money? Does anyone on this board have any idea of what a partnership like this may bring? In the past they said they are signing distributors. Today Mike said partnership but he also stumbled and stopped what he was going to say "Were on the cusp of announcing, ahh.." I am not sure which direction they are going. Of course things could change but distributors purchase the goods they sell and resell it. They have well defined territories. In my personal experience I never cared what my distributors did with my product as long as they met their contractual quotas and paid the invoice. For all I cared they could have taken all the product and thrown it in the trash. For sure one thing we did was push product on the distributors so they would exceed quotas and make bonus. We will need to wait for the details of the exact model MNKD is following and how good a negotiator Mike is. Right now, IMO between the new label and the $60M Mike is holding an ace high flush. We should not have to wait much longer for the answer. Thank you. |
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Post by joeypotsandpans on Oct 12, 2017 19:39:57 GMT -5
LFD just came out with another hit piece at exactly 4:02 pm on SA with a disgusting header too. You can't tell me that phony writer isn't with BP, nor is he not embedded somewhere here too. I'm so tired of that trash talk. Someday, he will be gone forever and crawl back to the hole he slithered out of! Btw, I did not read that trash piece, just saw the header and "author" which was enough for me. I stopped reading his garbage several years back. I rarely reply to SA and especially LFD. But had to with this one. (LFD title: MannKind: The State Of Denmark Isn't The Only Place Something Is Rotten)
LFD you finally got something right! There is something ROTTON IN DENMARK........
its at the Headquarters of:
Novo Nordisk A/S, Headquarters
Contact info
Head of Office: Mr Lars Fruergaard Jørgensen
He has a delivery problem as his products rely on using icky Needles and old school methods of treating diabetes. He should really investigate a new technology that has a patented method of delivery of Insulin its available from a company named MannKind.
But then again Writers like LFD have pronounced MannKind dead and buried with no pulse. So maybe the folks in Denmark are not aware of Afrezza and how easy it is to use. What immediate action it has for helping a Diabetic gain blood Glucose control. That it also has long term benefits as it reduces A1C. Funny, how this little pimple of a company can cause panic in the world of injected insulin companies.
I am glad your not invested as most of MannKind's investors while current bag holders are hopeful that one day if the company survives that it will make the lives of diabetics easier and more compliant towards good health and reduced complications that will = a longer life to enjoy.
The CEO of MannKind Mike Castagna is a very motivational person and seems the company heading in a better direction. Listen to some of his comments today on a radio show on the Biz Radio network.
bit.ly/2ydCo4a
Perhaps his Technosphere is filled with a new product called MannKind confidence.
For the Record I am a long term MannKind investor.
Love it, very clever with the rotten in Denmark twist  so so true! Mikey slinging the rocks at the Giant, rotten in Denmark too funny! |
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Post by casualinvestor on Oct 13, 2017 8:42:47 GMT -5
I was hoping he used up the whole atm around $6, but for some reason in my gut he only did 10 million shares from the atm because he is saving the others for when he announces the Brazil partnership and other news and thinks pps will be higher...obviously whoverever bought the first 10 million thinks it's worth more than $6.... My understanding is that the ATM is not share based but $ based. After the 10 million share offering, they still have 12 million shares to work with and shares sold on the ATM will come out of that. So if the ATM hasn't been used there's still $50 million waiting. As far as timing, there's a couple of ways to look at it. 1) Why use the ATM at all, rather than just make a slightly larger stock offering. 8 million vs 10 million vs 12 million shares. Then you have the whole ATM in reserve or 2) Use the ATM (maybe not all, but as much as you plan to use for a few months) before the stock offering if you really need the money (IMO they did for a couple million shares), because you know the stock is going to drop A Brazil filing will be good long-term news. We'll find out about the ATM at the quarterly meeting hopefully |
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Post by dreamboatcruise on Oct 13, 2017 15:50:28 GMT -5
I found this while looking for an Approval Timeline for Brazil: Brazil to Expedite Review and Approval Process, Recognize Foreign Audits and Inspections raps.org/focus-online/news/news-article-view/article/3072/<snip> Another goal is to reduce the time it takes the agency to review and approve applications from nine months on average to six months for technological innovation and priority medications for hypertension, diabetes and cancer. The reduction to six months would be consistent with the review time of other agencies such as the US Food and Drug Administration (FDA).
Among the other proposals announced is one allowing Anvisa to recognize audits and inspections carried out by other international agencies and accreditation bodies. </snip> I don't understand things as well as some of you guys But I thought mannkind had already filed paperwork in Brazil before the partnership was announced a few months back. I thought this happened when Matt was still CEO. Can someone clarify that for me. No understanding of it needed, but you are mistaken. Afrezza had not been submitted earlier for approval in Brazil. |
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Post by patten1962 on Oct 13, 2017 16:08:20 GMT -5
I don't understand things as well as some of you guys But I thought mannkind had already filed paperwork in Brazil before the partnership was announced a few months back. I thought this happened when Matt was still CEO. Can someone clarify that for me. No understanding of it needed, but you are mistaken. Afrezza had not been submitted earlier for approval in Brazil. Ty |
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so so true! Mikey slinging the rocks at the Giant, rotten in Denmark too funny!
