|
Post by mnkdnut on Jul 16, 2016 23:28:54 GMT -5
If Afrezza works best with CGM's then its clear why MNKD has been recommending/promoting CGM use despite the costs for the user. Mike was asking everyone to sign the petition regarding CGM use and dosing so its clear that they see its importance for Afrezza. I assumed that those reading my post understood that I was discussing collaboration not just recommendation of use and noted the issues with this as well. No question at the moment that the economics are problematic especially in the US where the health care provisions for supplying a CGM to a patient are restrictive (less so in other places where national heath care systems are more amenable). Perhaps that needs to change with changes in how far the US nationalizes health care to meet the demands of a population with an expansive diabetes problem. Dexcom and Medtronic are well known. Abbott is fighting for a share of this. Senseonics just got EU approval and San Meditech in China is a growing concern. The field and players as I said in my post are expanding. No doubt there will be more and this may have the effect of lowering costs. I don't think it has ever been proven that Afrezza works better with a CGM. What has happened is the social media Afrezza users with CGMs can post graphs of their numbers and pictures always get more attention. From that a belief has grown that you need a CGM to best use Afrezza and I can see no reason why that should be the case. In my view as an Afrezza user you should be less likely to need a CGM. National health systems are far more restrictive about the use of CGMs than the US. It is difficult to get a CGM and the acceptance criteria are extremely restricted. In most countries it requires regional sign-off to issue a CGM which is a big deal. I don't think France allows them at all. CGMs need to be around an order of magnitude cheaper than they are today to get taken up generally by the national health systems. I always thought the CGM's value to Afrezza use was as a training tool. The CGM allows the beginner A user to learn how much to take and when to take it over a variety of circumstances. After a few months of this accelerated learning though, I doubt they'd find nearly as much value out of their CGM. They've developed their own A usage "rules" by then, and have confirmed that they work. That's why a partnership with a CGM company is questionable. CGM manufacturers want long term users. MNKD may be wisely targeting existing CGM users as those likely to see/get the benefit the fastest. Beachhead.
|
|
|
Post by mnkdfann on Jul 17, 2016 0:14:50 GMT -5
I had this all written down but its on my work computer. I thought Al Man had around 132,000,0000 of shares between himself and the Mann Foundation.. I think it would be aggressive speculation if they got rid of a 1/3 to this point. Oh and more importantly there would be short shares available every where if they were sold. 153.2 million data.cnbc.com/quotes/MNKD/tab/8used to be 151.1, not sure when it changed but it did. Institutional ownership is reported quarterly, isn't it? I read that large holders have to report by the 15th of the second month following each quarter. So if that is correct, by mid-August we should have numbers current to the end of July. Right now, the figures at that link may be current only as far back as end of March.
|
|
|
Post by matt on Jul 17, 2016 7:29:28 GMT -5
Institutional ownership is reported quarterly, isn't it? I read that large holders have to report by the 15th of the second month following each quarter. So if that is correct, by mid-August we should have numbers current to the end of July. Right now, the figures at that link may be current only as far back as end of March. You are partially correct, institutional holders have to report 45 days after quarter end, but "large holders" and "institutional holders" are not the same thing. Institutional ownership reporting only applies to entities regulated under the Investment Act of 1940. That includes any entity that manages money for a third party in exchange for a fee such as mutual funds, index funds, and brokerages but, generally speaking, private foundations and family offices are not Investment Act companies and have zero reporting obligations. This is similar to the difference between public companies that must file 10K and 10Q reports with the SEC while privately held businesses do not. Investment Act reports are due regardless if the fund holds 10% of the shares or just 10 shares; holding size does not matter. The only way you will see changes in private holdings is if the individual entity has filed a 13D or 13G, which is required if the entity purchases more than 5% or if it makes a subsequent change equal to more than 1% of the shares outstanding. If Al Mann had 35% of the shares spread around 10 separate entities in roughly equal proportions, then each entity would only own 3.5% and would not have to file disclosures (there are complicated rules for figuring out if two entities are under common control and therefor must be combined for reporting, but I have not had enough coffee to even think about explaining that). The bottom line, if the various foundations and trusts that remained after Al's death each have less than 5% of the shares they can sell it all without having to report anything. You can be sure that Al's private wealth advisers thought carefully about such things when the structure was set-up in the first place, and the trustees will diversify the holdings quietly to avoid putting too much pressure on the PPS. Remember that the trustees that control the various foundations have a fiduciary obligation to act in the best interest of the trust even if that is not to the advantage of the company, and over concentration of holdings in a highly volatile company violates their legal obligation to act with prudence. Since the trustees can be sued by the beneficiaries, they tend to take such obligations very seriously.
|
|
|
Post by agedhippie on Jul 17, 2016 9:11:50 GMT -5
I don't think it has ever been proven that Afrezza works better with a CGM. What has happened is the social media Afrezza users with CGMs can post graphs of their numbers and pictures always get more attention. From that a belief has grown that you need a CGM to best use Afrezza and I can see no reason why that should be the case. In my view as an Afrezza user you should be less likely to need a CGM. National health systems are far more restrictive about the use of CGMs than the US. It is difficult to get a CGM and the acceptance criteria are extremely restricted. In most countries it requires regional sign-off to issue a CGM which is a big deal. I don't think France allows them at all. CGMs need to be around an order of magnitude cheaper than they are today to get taken up generally by the national health systems.How much do they cost the patient right now? Source? Around $6,100 per year. Dexcom.
|
|
|
Post by rossomalley on Jul 17, 2016 15:07:02 GMT -5
Institutional ownership is reported quarterly, isn't it? I read that large holders have to report by the 15th of the second month following each quarter. So if that is correct, by mid-August we should have numbers current to the end of July. Right now, the figures at that link may be current only as far back as end of March. You are partially correct, institutional holders have to report 45 days after quarter end, but "large holders" and "institutional holders" are not the same thing. Institutional ownership reporting only applies to entities regulated under the Investment Act of 1940. That includes any entity that manages money for a third party in exchange for a fee such as mutual funds, index funds, and brokerages but, generally speaking, private foundations and family offices are not Investment Act companies and have zero reporting obligations. This is similar to the difference between public companies that must file 10K and 10Q reports with the SEC while privately held businesses do not. Investment Act reports are due regardless if the fund holds 10% of the shares or just 10 shares; holding size does not matter. The only way you will see changes in private holdings is if the individual entity has filed a 13D or 13G, which is required if the entity purchases more than 5% or if it makes a subsequent change equal to more than 1% of the shares outstanding. If Al Mann had 35% of the shares spread around 10 separate entities in roughly equal proportions, then each entity would only own 3.5% and would not have to file disclosures (there are complicated rules for figuring out if two entities are under common control and therefor must be combined for reporting, but I have not had enough coffee to even think about explaining that). The bottom line, if the various foundations and trusts that remained after Al's death each have less than 5% of the shares they can sell it all without having to report anything. You can be sure that Al's private wealth advisers thought carefully about such things when the structure was set-up in the first place, and the trustees will diversify the holdings quietly to avoid putting too much pressure on the PPS. Remember that the trustees that control the various foundations have a fiduciary obligation to act in the best interest of the trust even if that is not to the advantage of the company, and over concentration of holdings in a highly volatile company violates their legal obligation to act with prudence. Since the trustees can be sued by the beneficiaries, they tend to take such obligations very seriously. Thank you for these very helpful comments, Matt!
|
|
|
Post by rossomalley on Jul 17, 2016 15:10:04 GMT -5
How much do they cost the patient right now? Source? Around $6,100 per year. Dexcom. And you too, AgedHippie. I really appreciate the objective and informative contributions you two are making. Glad I found this site!
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Jul 17, 2016 16:04:52 GMT -5
Institutional ownership is reported quarterly, isn't it? I read that large holders have to report by the 15th of the second month following each quarter. So if that is correct, by mid-August we should have numbers current to the end of July. Right now, the figures at that link may be current only as far back as end of March. You are partially correct, institutional holders have to report 45 days after quarter end, but "large holders" and "institutional holders" are not the same thing. Institutional ownership reporting only applies to entities regulated under the Investment Act of 1940. That includes any entity that manages money for a third party in exchange for a fee such as mutual funds, index funds, and brokerages but, generally speaking, private foundations and family offices are not Investment Act companies and have zero reporting obligations. This is similar to the difference between public companies that must file 10K and 10Q reports with the SEC while privately held businesses do not. Investment Act reports are due regardless if the fund holds 10% of the shares or just 10 shares; holding size does not matter. The only way you will see changes in private holdings is if the individual entity has filed a 13D or 13G, which is required if the entity purchases more than 5% or if it makes a subsequent change equal to more than 1% of the shares outstanding. If Al Mann had 35% of the shares spread around 10 separate entities in roughly equal proportions, then each entity would only own 3.5% and would not have to file disclosures (there are complicated rules for figuring out if two entities are under common control and therefor must be combined for reporting, but I have not had enough coffee to even think about explaining that). The bottom line, if the various foundations and trusts that remained after Al's death each have less than 5% of the shares they can sell it all without having to report anything. You can be sure that Al's private wealth advisers thought carefully about such things when the structure was set-up in the first place, and the trustees will diversify the holdings quietly to avoid putting too much pressure on the PPS. Remember that the trustees that control the various foundations have a fiduciary obligation to act in the best interest of the trust even if that is not to the advantage of the company, and over concentration of holdings in a highly volatile company violates their legal obligation to act with prudence. Since the trustees can be sued by the beneficiaries, they tend to take such obligations very seriously. Matt- What would your guess be? Do you think they are still sitting on a lot of the shares or they have sold a decent amount.
|
|
|
Post by anderson on Jul 17, 2016 18:11:58 GMT -5
You are partially correct, institutional holders have to report 45 days after quarter end, but "large holders" and "institutional holders" are not the same thing. Institutional ownership reporting only applies to entities regulated under the Investment Act of 1940. That includes any entity that manages money for a third party in exchange for a fee such as mutual funds, index funds, and brokerages but, generally speaking, private foundations and family offices are not Investment Act companies and have zero reporting obligations. This is similar to the difference between public companies that must file 10K and 10Q reports with the SEC while privately held businesses do not. Investment Act reports are due regardless if the fund holds 10% of the shares or just 10 shares; holding size does not matter. The only way you will see changes in private holdings is if the individual entity has filed a 13D or 13G, which is required if the entity purchases more than 5% or if it makes a subsequent change equal to more than 1% of the shares outstanding. If Al Mann had 35% of the shares spread around 10 separate entities in roughly equal proportions, then each entity would only own 3.5% and would not have to file disclosures (there are complicated rules for figuring out if two entities are under common control and therefor must be combined for reporting, but I have not had enough coffee to even think about explaining that). The bottom line, if the various foundations and trusts that remained after Al's death each have less than 5% of the shares they can sell it all without having to report anything. You can be sure that Al's private wealth advisers thought carefully about such things when the structure was set-up in the first place, and the trustees will diversify the holdings quietly to avoid putting too much pressure on the PPS. Remember that the trustees that control the various foundations have a fiduciary obligation to act in the best interest of the trust even if that is not to the advantage of the company, and over concentration of holdings in a highly volatile company violates their legal obligation to act with prudence. Since the trustees can be sued by the beneficiaries, they tend to take such obligations very seriously. Matt- What would your guess be? Do you think they are still sitting on a lot of the shares or they have sold a decent amount. Also I believe if Al's foundations bought during the stock offering to avoid dilution that would also not be reportable since their % didn't change. The only way to know for sure is to wait till next years share holder meeting.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Jul 17, 2016 19:53:58 GMT -5
Matt- What would your guess be? Do you think they are still sitting on a lot of the shares or they have sold a decent amount. Also I believe if Al's foundations bought during the stock offering to avoid dilution that would also not be reportable since their % didn't change. The only way to know for sure is to wait till next years share holder meeting. they could have just bought direct not thru that institution.. so you dont have to wait till next year
|
|
|
Post by surplusvalue on Jul 17, 2016 20:45:13 GMT -5
If Afrezza works best with CGM's then its clear why MNKD has been recommending/promoting CGM use despite the costs for the user. Mike was asking everyone to sign the petition regarding CGM use and dosing so its clear that they see its importance for Afrezza. I assumed that those reading my post understood that I was discussing collaboration not just recommendation of use and noted the issues with this as well. No question at the moment that the economics are problematic especially in the US where the health care provisions for supplying a CGM to a patient are restrictive (less so in other places where national heath care systems are more amenable). Perhaps that needs to change with changes in how far the US nationalizes health care to meet the demands of a population with an expansive diabetes problem. Dexcom and Medtronic are well known. Abbott is fighting for a share of this. Senseonics just got EU approval and San Meditech in China is a growing concern. The field and players as I said in my post are expanding. No doubt there will be more and this may have the effect of lowering costs. I don't think it has ever been proven that Afrezza works better with a CGM. What has happened is the social media Afrezza users with CGMs can post graphs of their numbers and pictures always get more attention. From that a belief has grown that you need a CGM to best use Afrezza and I can see no reason why that should be the case. In my view as an Afrezza user you should be less likely to need a CGM. National health systems are far more restrictive about the use of CGMs than the US. It is difficult to get a CGM and the acceptance criteria are extremely restricted. In most countries it requires regional sign-off to issue a CGM which is a big deal. I don't think France allows them at all. CGMs need to be around an order of magnitude cheaper than they are today to get taken up generally by the national health systems. You'll notice my post began with the provision "If" so it already precludes that "it has ever been proven that Afrezza works better with a CGM" and clearly did not make such an assertion. Noticed you have had this discussion on the "Holy Grail" thread as well. Management seems to think that the benefits of using Afrezza with a CGM is substantial and they have reiterated this view publicly more than once. It may be the case, that CGM use for initial dosing and beginning on Afrezza is optimal. After that it may depend on the individual's need for continuous monitoring as opposed to self monitoring using the many non continuous devices on the market now. Discussions regarding short term vs long term use of CGM's are present in diabetes literature/sites.
|
|
|
Post by surplusvalue on Jul 17, 2016 20:49:40 GMT -5
I don't think it has ever been proven that Afrezza works better with a CGM. What has happened is the social media Afrezza users with CGMs can post graphs of their numbers and pictures always get more attention. From that a belief has grown that you need a CGM to best use Afrezza and I can see no reason why that should be the case. In my view as an Afrezza user you should be less likely to need a CGM. National health systems are far more restrictive about the use of CGMs than the US. It is difficult to get a CGM and the acceptance criteria are extremely restricted. In most countries it requires regional sign-off to issue a CGM which is a big deal. I don't think France allows them at all. CGMs need to be around an order of magnitude cheaper than they are today to get taken up generally by the national health systems. I always thought the CGM's value to Afrezza use was as a training tool. The CGM allows the beginner A user to learn how much to take and when to take it over a variety of circumstances. After a few months of this accelerated learning though, I doubt they'd find nearly as much value out of their CGM. They've developed their own A usage "rules" by then, and have confirmed that they work. That's why a partnership with a CGM company is questionable. CGM manufacturers want long term users. MNKD may be wisely targeting existing CGM users as those likely to see/get the benefit the fastest. Beachhead. The need for short vs long term CGM monitoring likely depends upon individual circumstances aside from benefit/cost calculations. And promotion/recommendation, collaboration and partnership are not all the same thing. See my response to "peppy" mnkd.proboards.com/thread/5857/afrezza-tresiba-new-holy-grail?page=2
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Jul 17, 2016 22:18:47 GMT -5
Matt- What would your guess be? Do you think they are still sitting on a lot of the shares or they have sold a decent amount. Also I believe if Al's foundations bought during the stock offering to avoid dilution that would also not be reportable since their % didn't change. The only way to know for sure is to wait till next years share holder meeting. Anderson I def respect your thoughts but I fail to understand why they would buy.
|
|
|
Post by mnkdnut on Jul 17, 2016 22:52:21 GMT -5
I always thought the CGM's value to Afrezza use was as a training tool. The CGM allows the beginner A user to learn how much to take and when to take it over a variety of circumstances. After a few months of this accelerated learning though, I doubt they'd find nearly as much value out of their CGM. They've developed their own A usage "rules" by then, and have confirmed that they work. That's why a partnership with a CGM company is questionable. CGM manufacturers want long term users. MNKD may be wisely targeting existing CGM users as those likely to see/get the benefit the fastest. Beachhead. The need for short vs long term CGM monitoring likely depends upon individual circumstances aside from benefit/cost calculations. And promotion/recommendation, collaboration and partnership are not all the same thing. See my response to "peppy" mnkd.proboards.com/thread/5857/afrezza-tresiba-new-holy-grail?page=2 Sure, I agree that Afrezza users can find a range of usefulness in CGMs in the short and long terms. What we've observed though are a few reports of committed Afrezza users dropping use of CGMs while I've not heard of any reports of any adding it. I'm sure many just keep using their CGM after adopting Afrezza, but no data there to speak of. So far, what's been reported by users seems to support the idea that the better control they have with Afrezza seems to lessen the utility of their CGM. Of course, there could be any number of ways MNKD can structure cooperative promotion with a CGM manufacturer. Dexcom, with CEO Kevin Sayer having had a long and close business relationship with Al Mann, would be in the driver's seat to capitalize on that opportunity if they had an interest. So far though, no reported activity or stated support for Afrezza from Dexcom. Doesn't mean something can't or won't happen, but you have to wonder what's taking so long if there is any interest.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Jul 19, 2016 1:24:03 GMT -5
totally agree. Desisto becomes available in Sept 2016 if i recall correctly I find the speculation about Desisto interesting. What has he been doing since his hire at Mnkd fell through? Is he just sitting at home collecting unemployment, waiting for a call from Mannkind? No other compny wanted / wants him? Or did some other company hire him, even though ( apparently) everyone knows he is moving to Mnkd asap? Easy. He is a Director for Stereotaxis, Inc. ir.stereotaxis.com/phoenix.zhtml?c=179896&p=irol-governance
|
|
|
Post by mnkdfann on Jul 19, 2016 2:05:52 GMT -5
I find the speculation about Desisto interesting. What has he been doing since his hire at Mnkd fell through? Is he just sitting at home collecting unemployment, waiting for a call from Mannkind? No other compny wanted / wants him? Or did some other company hire him, even though ( apparently) everyone knows he is moving to Mnkd asap? Easy. He is a Director for Stereotaxis, Inc. ir.stereotaxis.com/phoenix.zhtml?c=179896&p=irol-governanceYeah, but he has been doing that since May of 2015. It's not a full-time gig (like the Mnkd appointment would have been), which is what I was talking about. ir.stereotaxis.com/phoenix.zhtml?c=179896&p=irol-newsArticle&ID=2043201(Not that it matters, but STXS is also a tiny company (31M market cap) that hasn't done particularly well since he joined its board.)
|
|