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Post by dstevenson on Dec 10, 2015 9:45:16 GMT -5
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Post by me on Dec 10, 2015 9:52:23 GMT -5
Page 28, Top Slide - "ultra rapid acting inhaled insulin"  !!! |
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Post by Deleted on Dec 10, 2015 9:58:16 GMT -5
Page 28, Top Slide - "ultra rapid acting inhaled insulin" !!! thats in Edelman's notes.. he can choose to say what he wants I guess , but not SNY |
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Post by factspls88 on Dec 10, 2015 10:27:01 GMT -5
Page 28, Top Slide - "ultra rapid acting inhaled insulin" !!! This is fantastic! Thanks for posting. Hosting a meeting like this says to me that Sanofi is committed - not that I really doubted but as we know others have been concerned. If Sanofi were planning on bailing they wouldn't hold such a meeting - their credibility in the professional diabetic community would be shot. |
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Post by mnkdfann on Dec 10, 2015 10:42:54 GMT -5
Page 28, Top Slide - "ultra rapid acting inhaled insulin" !!! This is fantastic! Thanks for posting. Hosting a meeting like this says to me that Sanofi is committed - not that I really doubted but as we know others have been concerned. If Sanofi were planning on bailing they wouldn't hold such a meeting - their credibility in the professional diabetic community would be shot. Just as a point of clarification, unless I missed something, the slides are NOT from the meeting Sanofi hosted. |
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Post by dreamboatcruise on Dec 10, 2015 10:50:43 GMT -5
Edit: by sending patient glucose readings directly to smartphone, the phone can send it up to the Google cloud and patient can get feedback, good, bad or otherwise. A message to reduce carbs, take insulin 5 min after starting meal are a couple of examples. Artificial intelligence makes it nearly infinite as to what type of patient feedback would result based on glucose levels and other patient data that is constantly fed up to google cloud via sensor patient wears. Also, 3 of Dexcoms top management including Terry Greg and Kevin Sayer worked for Al Mann at Minimed. I could be wrong, but I think we're a LONG way off from this sort of thing. I believe the FDA views anything that does this sort of drug dosing as squarely within their realm of jurisdiction and would require the usual extensive clinical trials... and contrary to what others have speculated here, the article you provide a link to says that Dexcom expects the new sensor technology to be 2-3 years from the market, so any AI based dosing would probably be another 1-2 years minimum on top of that (a guess). I'm not suggesting that Google can't do great things in medicine, and particularly in diabetes, but I certainly wouldn't count on news from their efforts to impact MNKD anytime in the near future. There would be no reason for Google to hitch their efforts to one prandial over another this early in the development of all of this. |
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Post by dreamboatcruise on Dec 10, 2015 10:55:11 GMT -5
Page 28, Top Slide - "ultra rapid acting inhaled insulin" !!! This is fantastic! Thanks for posting. Hosting a meeting like this says to me that Sanofi is committed - not that I really doubted but as we know others have been concerned. If Sanofi were planning on bailing they wouldn't hold such a meeting - their credibility in the professional diabetic community would be shot. Hopefully this FUD notion of SNY dropping Afrezza will be put to rest soon. I doubt this meeting alone does it, but something will. That hopefully forms a floor for share price. |
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Post by mssciguy on Dec 10, 2015 11:00:57 GMT -5
By Charles Gave, courtesy of John Maudlin The Apex Of Market Stupidity In some 40 years of watching financial markets, my dominant emotion has been a mixture of curiosity, amusement and despair. It seems the stock market must have been invented to make the maximum number of people miserable for the greatest possible amount of time. dreamboatcruise |
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Post by mindovermatter on Dec 10, 2015 11:06:50 GMT -5
Page 28, Top Slide - "ultra rapid acting inhaled insulin" !!! This is fantastic! Thanks for posting. Hosting a meeting like this says to me that Sanofi is committed - not that I really doubted but as we know others have been concerned. If Sanofi were planning on bailing they wouldn't hold such a meeting - their credibility in the professional diabetic community would be shot. Or they are assessing if they should further their commitment. Remember, Sanofi is a business. They know how much they want to commit to Afrezza before they pull the plug. Sanofi knows exactly what Afrezza does and how well it works but their problem is convincing doctors and insurance companies. The question is how committed is Sanofi? MNKDs run to the TASE to raise capital tells me that Sanofi wasn't ready to further their commitment to their partner. I could be misinterpreting Mannkind's TASE move but that is how I read the move. If so, the beginning of 2016 is going to be very telling as to the future of Mannkind. |
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Post by dreamboatcruise on Dec 10, 2015 11:12:18 GMT -5
Great info, thanks for sharing. For any of you who know and understand the regulatory process, will any of the studies that Sanofi has just completed allow the label to be changed to say "Ultra Rapid Acting" and / or "Reduces incidences of hypoglycemia" and / or "Reduces A1c"? If none of the current studies (assuming the data supports the claim) will allow for these label changes, what kind of studies would allow for this and how long would they take to complete? Ultra Rapid Acting and Reduced Hypoglycemia on the label and we are off the to races. Even if the Spirometery requirement and Prior Authorization issues stayed around. Ditto on that tweet... indeed, very encouraging. Put a smile on my face even with the share price where it is. I'm no expert on regulatory filings (though I guess I've learned a lot more about them than I ever would have thought because of MNKD), but the clamp studies are way to short to effect A1c and by there very nature wouldn't have any incidence of hypoglycemia (unless they are being done by a dangerously incompetent clinician). So those two metrics have nothing to do with these clamp studies. As for "ultra", these studies are basically more exhaustive versions of clamp studies already done. We already had data clearly showing quicker clearance from the system, and that didn't warrant "ultra" in FDA's eyes... though the graph is clearly in the material supplied to physicians and patients. If these new clamp studies clear up the issue of faster onset, would the FDA then allow "ultra" in the description... maybe? I wouldn't count on it though. They may well want to have a trial showing that there is some clinical benefit to the time profile in order to give a designation setting Afrezza apart from other insulins. If the FDA does grant "ultra" simply from clamp studies, I think we'd clearly have SNY to thank, because MNKD has not been treated kindly by the FDA in the past and "ultra" at this point is going to require a friendly hearing at the FDA, not a hostile one... because "ultra" would be a judgement call not one where there is any agreed on end point in the studies as to what would qualify as "ultra". |
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Post by dreamboatcruise on Dec 10, 2015 11:18:21 GMT -5
This is fantastic! Thanks for posting. Hosting a meeting like this says to me that Sanofi is committed - not that I really doubted but as we know others have been concerned. If Sanofi were planning on bailing they wouldn't hold such a meeting - their credibility in the professional diabetic community would be shot. Or they are assessing if they should further their commitment. Remember, Sanofi is a business. They know how much they want to commit to Afrezza before they pull the plug. Sanofi knows exactly what Afrezza does and how well it works but their problem is convincing doctors and insurance companies. The question is how committed is Sanofi? MNKDs run to the TASE to raise capital tells me that Sanofi wasn't ready to further their commitment to their partner. I could be misinterpreting Mannkind's TASE move but that is how I read the move. If so, the beginning of 2016 is going to be very telling as to the future of Mannkind. You are conflating two very separate issues. SNY's commitment to Afrezza has nothing to do with MNKD raising capital. The agreement between SNY and MNKD gives SNY access to Afrezza even if MNKD disappears (no I am not predicting that will happen). SNY has no reason to further their commitment to their "partner" MNKD regarding MNKD share price. Conceivably they may view some buy in as being a good investment, but they aren't going to do it to help out MNKD shareholders. |
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Post by mnholdem on Dec 10, 2015 12:20:28 GMT -5
On that separate issue (if I may stray for a moment) I'm wondering if suggestions that MannKind ran to the TASE for financing (above) are really painting an accurate picture. Unless he is misleading us, which I don't think he can since his remark is so easily disproven, Matt Pfeffer's statement on the matter was that it was some of the Israeli TASE fund managers who approached and asked to help MannKind directly by purchasing shares directly from the company. Many Wall Street pundits are reporting that it was MannKind who went to the TASE for financing and that they were largely rejected. But is that really what happened? I don't think so, based on Matt Pfeffer's comment on the matter from the last earnings call:
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Source: seekingalpha.com/article/3669586-mannkinds-mnkd-ceo-hakan-edstrom-on-q3-2015-results-earnings-call-transcript?page=2
As background to this deal, some of you may know that our Chairman, Al Mann, has a history of involvement in medical research in collaboration with Israeli-based entities. Perhaps the best known of these is his donation of over $100 million to establish the Alfred Mann Institute at the Technion, which supports the development and commercialization of biomedical innovation conceived by Technion researchers. He has also engaged in business partnerships with pioneering Israeli companies. So it was a logical step for MannKind to pursue the idea of the company listing on the Tel Aviv Stock Exchange.
Per Tel Aviv Stock Exchange rules, MannKind being listed on the exchange means we are now included in several major index funds, which are now required to maintain substantial ownership positions in MannKind shares. These shares must be accumulated within a prescribed period following such listing.
During the listing process, some of these funds approached us suggesting they buy the shares from us directly, thus allowing their cash investment to be put to work inside the company. We expect that the majority of shares for index fund purchases will be issued directly for MannKind, with remaining demand required to be satisfied by open market purchasers from existing holders to fulfill these ownership requirements. All purchases are expected to be completed within the next week.
Selling directly to these index funds offers critical benefits to MannKind shareholders. First, that these index funds are required to hold the stock essentially indefinitely as long as we are included in the associated index, providing a stabilizing force in the market. Second, the index funds are required to hold the shares, and not make them available for lending. And therefore, will not be part of a potential shorting pool here in the U.S.
You will remember that I have said more than once that the last form of financing I thought we should consider would be a traditional marketed secondary offering. There are many reasons for this, not the least of which is that such an offering would play into the hands of those who short our stock, allowing them a painless way to unwind their positions.
With that in mind, the Tel Aviv Stock Exchange listing and related index fund purchases provides a creative solution to MannKind's financing needs.
So in conclusion, we're pleased to enter the fourth quarter with the financial resources to fully support Afrezza's operations, as well as advance MannKind's product development efforts currently in process. With these transactions, we expect to fund the company's operations into 2017, and ensure we have the staying power to realize Afrezza's potential, and also leverage the Technosphere platform into new areas.
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While it was made clear that MannKind Corporation wanted to be listed on the TASE, I haven't seen conclusive evidence that the intent was for financing. Perhaps some would suggest that I am naïve to not think that Al had some background role in TASE purchasing shares directly. Maybe I am, but I don't believe that I'm being delusional by believing Alfred Mann likely has more than just a few friends who want to see MannKind Corporation survive.
Some might also also argue that Matt's final sentence of "ensuring staying power to realize Afrezza's potential" indicates that MannKind believes that shareholders will see that potential demonstrated in 2016. It did have the ring of a timeline to it... without violating any NDA provisions within the License & Collaboration Agreement with Sanofi.
Good fortune all. 
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Post by factspls88 on Dec 10, 2015 12:49:40 GMT -5
This is fantastic! Thanks for posting. Hosting a meeting like this says to me that Sanofi is committed - not that I really doubted but as we know others have been concerned. If Sanofi were planning on bailing they wouldn't hold such a meeting - their credibility in the professional diabetic community would be shot. Just as a point of clarification, unless I missed something, the slides are NOT from the meeting Sanofi hosted. The very first slide shows the date and the venue. What did I miss? |
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Post by u1682002 on Dec 10, 2015 12:53:35 GMT -5
On that separate issue (if I may stray for a moment) I'm wondering if suggestions that MannKind ran to the TASE for financing (above) are really painting an accurate picture. Unless he is misleading us, which I don't think he can since his remark is so easily disproven, Matt Pfeffer's statement on the matter was that it was some of the Israeli TASE fund managers who approached and asked to help MannKind directly by purchasing shares directly from the company. Many Wall Street pundits are reporting that it was MannKind who went to the TASE for financing and that they were largely rejected. But is that really what happened? I don't think so, based on Matt Pfeffer's comment on the matter from the last earnings call:
---
Source: seekingalpha.com/article/3669586-mannkinds-mnkd-ceo-hakan-edstrom-on-q3-2015-results-earnings-call-transcript?page=2
As background to this deal, some of you may know that our Chairman, Al Mann, has a history of involvement in medical research in collaboration with Israeli-based entities. Perhaps the best known of these is his donation of over $100 million to establish the Alfred Mann Institute at the Technion, which supports the development and commercialization of biomedical innovation conceived by Technion researchers. He has also engaged in business partnerships with pioneering Israeli companies. So it was a logical step for MannKind to pursue the idea of the company listing on the Tel Aviv Stock Exchange.
Per Tel Aviv Stock Exchange rules, MannKind being listed on the exchange means we are now included in several major index funds, which are now required to maintain substantial ownership positions in MannKind shares. These shares must be accumulated within a prescribed period following such listing.
During the listing process, some of these funds approached us suggesting they buy the shares from us directly, thus allowing their cash investment to be put to work inside the company. We expect that the majority of shares for index fund purchases will be issued directly for MannKind, with remaining demand required to be satisfied by open market purchasers from existing holders to fulfill these ownership requirements. All purchases are expected to be completed within the next week.
Selling directly to these index funds offers critical benefits to MannKind shareholders. First, that these index funds are required to hold the stock essentially indefinitely as long as we are included in the associated index, providing a stabilizing force in the market. Second, the index funds are required to hold the shares, and not make them available for lending. And therefore, will not be part of a potential shorting pool here in the U.S.
You will remember that I have said more than once that the last form of financing I thought we should consider would be a traditional marketed secondary offering. There are many reasons for this, not the least of which is that such an offering would play into the hands of those who short our stock, allowing them a painless way to unwind their positions.
With that in mind, the Tel Aviv Stock Exchange listing and related index fund purchases provides a creative solution to MannKind's financing needs.
So in conclusion, we're pleased to enter the fourth quarter with the financial resources to fully support Afrezza's operations, as well as advance MannKind's product development efforts currently in process. With these transactions, we expect to fund the company's operations into 2017, and ensure we have the staying power to realize Afrezza's potential, and also leverage the Technosphere platform into new areas.
---
While it was made clear that MannKind Corporation wanted to be listed on the TASE, I haven't seen conclusive evidence that the intent was for financing. Perhaps some would suggest that I am naïve to not think that Al had some background role in TASE purchasing shares directly. Maybe I am, but I don't believe that I'm being delusional by believing Alfred Mann likely has more than just a few friends who want to see MannKind Corporation survive.
Mn, I would very much like to hear your opinion about the latest financing through TASE: management mistake or good move? Personally I think this is a mistake from the management and it got me very frustrated. They could have settled their bonds by issuing 20mil shares back in August when MNKD stock price still in 4s. Instead they got us in this financial mess: Low cash/sp in all time. |
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Post by bradleysbest on Dec 10, 2015 13:06:29 GMT -5
And we know 2 of the 12 Afrezza users that presented their situation to the advisory board!
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!!!
