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Post by BlueCat on Feb 19, 2016 14:54:58 GMT -5
Given the gap between the EYES and Mannkind timing, I think Al needed the time put the final pieces in place for Mannkind going forward. I expect we'll hear a much bigger story within a few weeks, partnership or sale. Myself, I doubt the few days of separation between announcements means anything more than someone on vacation not being available to sign a form, or write up a press release, as quickly as was done at the other company. Or maybe even more likely, they just spaced the announcements out so one did not detract from the other; two chances to praise Al and get him in the news instead of just once. More likely, they wanted to do a vote of the board to have the replacement announced at the same time for a smooth transition. And had to get it on everyone's calendars. And there was no need to do both at once. Besides, I think having the 'hint' this was to occur first with EYES may have actually helped in this circumstance, combined with the RBC event to address it next week. |
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Post by Deleted on Feb 19, 2016 17:40:50 GMT -5
No one is buying MNKD without the trial data from SNY. Do you guys see what happens when you invest in user reviews? No ones paying a premium for MNKD based of Adam Lasher and Sam Finta twitter reviews........ The clamp studies? Those are basically extended versions of what has already been done. I'm sure no company would buy MNKD until after full rights to Afrezza have transitioned back, but the data from the completed trials I doubt is a significant factor. Sorry if I came off douchey I was having a bad morning. I totally agree with you there is no sale until rights are back. As per Matt Post marketing results are statistically significant. He mentioned that at JPM and the investor call. He also mentioned that they wanted to release this data at ADA as it is a strong platform. I am work in sales, I negotiate in every deal that I do. Yes, I am that guy. If I were trying to negotiate a price I would drop this data at ADA. I would use this data to get a bette price for the company. Thus my thought on why MNKD is not being bought without people seeing that data. If its an extended version of what has already am I miss reading that they are making it bigger then it is? Mnholdem- I am assuming MNKD was not allowed to share the data with anyone until rights are transferred back to MNKD since technically it is property of SNY. I should have clarified my thoughts but I suck at that big time! |
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Post by dreamboatcruise on Feb 19, 2016 17:59:21 GMT -5
@reverselo... I think you might be assuming that "statistically significant" implies something about the clinical benefit of Afrezza, which it doesn't. These studies are not ones designed to show that Afrezza can lower A1c or reduce incidence of hypos. The only thing MNKD has indicated that might come out of this trial is that these results may allow them to get the ketoacidosis restriction removed from the label. I don't think that alone would make someone pay more for MNKD... as that restriction is never cited as a contributing factor to low sales. I think you're reading between the lines something that isn't there. There could have been results that would be bad... i.e. showing variability of the pk profile or inconsistent with previous clamp studies. I assume based on what Matt said that these new studies were successful and what was expected and that investors need not worry about any surprises from the data.
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Post by jpg on Feb 19, 2016 18:09:25 GMT -5
The small (and cheap to do) clamp studies are minor non 'clinical practice' studies. They do not carry as much weight as the vast majority of posters here give them. So far no really important study has been done. That was our first (or second or third  ?) clue... Ketoacidosis is a clinical entity and I don't see how the clamp studies could change that part of the label? Who said that? It doesn't seem plausible to me anyway. With a lot of luck what could change is the rapid vs ultrarapid designation maybe? It would take a friendly FDA: how has that worked so far? |
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Post by falconquest on Feb 19, 2016 19:02:50 GMT -5
I think it's more likely now that we get sold. Possibly someone wanted Al off the BOD and not attached to company before bidding? But yes, poor health could also be reason. Oh wow! I have never believed this but your post made me wonder.....is it possible that Sanofi will bid for Mannkind and wanted Al off the board as a condition of the offer? Could they then use the clamp study results and cover their butts by saying....."Well, we realize that our efforts to market Afrezza were not very successful but further studies have shown it's efficacy and so we're willing to move forward knowing the favorable results in those patients who use Afrezza" or some such lame excuse? I know, I know, this is highly speculative and I would never guess that Sanofi would be interested. There has been much speculation about this but with Al out of the way......? |
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Post by dreamboatcruise on Feb 19, 2016 19:32:18 GMT -5
The small (and cheap to do) clamp studies are minor non 'clinical practice' studies. They do not carry as much weight as the vast majority of posters here give them. So far no really important study has been done. That was our first (or second or third ?) clue... Ketoacidosis is a clinical entity and I don't see how the clamp studies could change that part of the label? Who said that? It doesn't seem plausible to me anyway. With a lot of luck what could change is the rapid vs ultrarapid designation maybe? It would take a friendly FDA: how has that worked so far? One of the just completed clamp studies has this description when listed as a postmarket requirement.
Description: Conduct a dose-ranging PK-PD euglycemic glucose-clamp trial to characterize the dose-response of Afrezza relative to subcutaneous insulin in patients with type 1 diabetes. Select at least three to four doses for each route of insulin administration to ensure both the linear and curvilinear portions of the dose-response curves are adequately captured and characterized. Compare the dose-response curves for Afrezza and subcutaneous insulin noting the dose at which the response becomes curvilinear for each. These data may impact labeling recommendations for dosing and thereby mitigate the risk of diabetic ketoacidosis, which has been observed with Afrezza.
So actually this doesn't even imply any risk or warning would be removed from label, simply that the dosing recommendation might be different. I think somehow this has morphed into a belief that the restriction on using Afrezza to treat ketoacidosis would be removed... or something. And of course others wishfully believe that these clamp studies are the ones not yet started to show superiority. |
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Post by BlueCat on Feb 19, 2016 19:53:33 GMT -5
I think it's more likely now that we get sold. Possibly someone wanted Al off the BOD and not attached to company before bidding? But yes, poor health could also be reason. Oh wow! I have never believed this but your post made me wonder.....is it possible that Sanofi will bid for Mannkind and wanted Al off the board as a condition of the offer? Could they then use the clamp study results and cover their butts by saying....."Well, we realize that our efforts to market Afrezza were not very successful but further studies have shown it's efficacy and so we're willing to move forward knowing the favorable results in those patients who use Afrezza" or some such lame excuse? I know, I know, this is highly speculative and I would never guess that Sanofi would be interested. There has been much speculation about this but with Al out of the way......? If they were going down this path they would not have depositioned the product as far as they did in the comments to the media on why the ditched. Nope. I think this one is done. |
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Post by dictatorsaurus on Feb 19, 2016 20:04:16 GMT -5
Sanofi is gone, done, history, it's over.
They're busy trashing Afrezza and throwing it under the bus.
They're not going to U-turn and buy it out. The lawsuites alone would be devastating from them misleading investors.
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Post by kdaddyfresh2000 on Feb 19, 2016 22:32:26 GMT -5
Sanofi is gone, done, history, it's over. They're busy trashing Afrezza and throwing it under the bus. They're not going to U-turn and buy it out. The lawsuites alone would be devastating from them misleading investors. For good or ill, it looks like our long nightmare is almost over. In that vein (hopefully in jest!): youtu.be/O5zGkqAWsWE |
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Post by LosingMyBullishness on Feb 20, 2016 7:20:02 GMT -5
falon,
in the corporate french world the board of SNY are gods and they never fail in their decisions. MNKD was a fly that was squidged either when Brandicourt took over or Mid of last year when SNY realized how good Afrezza is. Al Mann is probably just that very old man in the U.S. This is not a personal thing, they just do not care.
This could be an advantage now: If they had made the directive that MNKD should be destroyed MNKD will be destroyed. If they do not bother or did not examined properly the other TS opportunties, MNKD might have a chance to stay long enough in business to establish Afrezza.
SNY knows basically everything now about Afrezza: They know preliminary results of studies, they know about weaknesses in studies, they know about concerns of endos and (after last years come together with early adopters) real experience by Afrezza users.
So SNY is MNKD's biggest threat, a real Goliath, Leviathan.
I also do not believe that Viebacher has been different. A Directeur Général is a Directeur Général.
My hope is with TS partners with upfront payment that allow MNKD to stay in business, something SNY can not forsee because they did not bundle their dispersed experience to evaluate it thoroughly, a disadvantage in such a hierarchical multi-national entity.
I believe this is also how the institutional shorts evaluate it and sadly they were proven right so far.
Disc: Overly bullish retail investor with 12k shares and some options.
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Post by liane on Feb 20, 2016 7:35:43 GMT -5
SNY knows basically everything now about Afrezza: They know preliminary results of studies, they know about weaknesses in studies, they know about concerns of endos and (after last years come together with early adopters) real experience by Afrezza users. So SNY is MNKD's biggest threat, a real Goliath, Leviathan. Very interesting perspective, and maybe a systemic MO. Partner long enough to learn partners secrets, and then a quickie divorce. Could be worth the few hundred million dollar price tag; pocket change to them. |
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Post by falconquest on Feb 20, 2016 7:55:54 GMT -5
SNY knows basically everything now about Afrezza: They know preliminary results of studies, they know about weaknesses in studies, they know about concerns of endos and (after last years come together with early adopters) real experience by Afrezza users. So SNY is MNKD's biggest threat, a real Goliath, Leviathan. Very interesting perspective, and maybe a systemic MO. Partner long enough to learn partners secrets, and then a quickie divorce. Could be worth the few hundred million dollar price tag; pocket change to them. Yes but to what end? Eliminate the threat of Afrezza? Sanofi has no golden goose to protect unless you mean Apidra. Toujeo certainly isn't stellar and it's basal anyway. Seems a lame way to go about business to me. |
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Post by LosingMyBullishness on Feb 20, 2016 8:11:12 GMT -5
Falcon,
Early adopters pointed out that Afrezza allowed them to use less basal insulin. I looked at the script numbers and I saw a drop in active promotion middle of last year around ADA.
My hindsight is that they made a slow start to understand how much Afrezza would cannibalize their other diabetics medication esp. Toujou as this has major board attention. They figured out that is would cannibalize in the long run but that it would also need significant attention by sales&marketing AND 10 year plan for Toujou was already finalized and no middle management was eager to go to the board with a "risky change of plan".
I found that it is often not the case that top management changes plans to go for the better product or the one that might offer higher margin/market shares in the long run. If it is not in the master plan and risky they avoid it. It is less organisational hassle, less personal risk and they get paid anyway.
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Post by mnholdem on Feb 20, 2016 8:33:16 GMT -5
SNY knows basically everything now about Afrezza: They know preliminary results of studies, they know about weaknesses in studies, they know about concerns of endos and (after last years come together with early adopters) real experience by Afrezza users. So SNY is MNKD's biggest threat, a real Goliath, Leviathan. Very interesting perspective, and maybe a systemic MO. Partner long enough to learn partners secrets, and then a quickie divorce. Could be worth the few hundred million dollar price tag; pocket change to them. I wonder if everybody may be talking around the REAL issue here. Who was Sanofi's target? Early diabetes patients. Those who were either insulin naive or whose condition merits insulin intensification. I have posted many studies that prove early insulin treatment can lead to remission of diabetes. The latest study of over 800 patients given short-term intensive insulin treatment results showed 40%-60% drug-free remissions ranging from 6 to 24 months. Early diabetics were targeted and studied by Sanofi. What if the results were showing remissions? How would a a CEO or BoD of global diabetes giant respond to an insulin whose early use ELIMINATES the need for ANY diabetes drug? This is why I think Sanofi ran scared. I think that they were able to confirm that Afrezza has the potential to revolutionize diabetes treatment and greatly impact the epidemic of diabetes mellitus by significantly reducing the number of patients needing any further drug treatment. The impact of early (and short-term) treatment with Afrezza could literally be tens of $billions of diabetes drugs that will no longer be needed or prescribed because of the ability of Afrezza to repair pancreatic beta cells if administered early enough. Even MannKind would be affected because STII therapy would mean prescribing Afrezza for only 4 weeks. The revenue that would make Afrezza a blockbuster would have to come from diabetics whose pancreas is damaged beyond repair and for whom Afrezza is a life-changing, safe and easy-to-use mealtime insulin. Early adopters are giving testimonials about Afrezza's healing effects. It's not a miracle. It's science. This science developed by Alfred Mann scared the hell out of Sanofi. At least that's what I think has happened. |
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Post by falconquest on Feb 20, 2016 8:38:29 GMT -5
Falcon, Early adopters pointed out that Afrezza allowed them to use less basal insulin. Yeah, I get that. So you spend a couple hundred million to deep six a mealtime insulin and then have to lower your basal insulin prices in order to maintain competitiveness in the U.S. market? See here from a Bloomberg story talking about pill forms of treatment.... Sanofi, Novo Slump as Diabetes Moves on From Insulin Tradition: "For moving on to insulin, there’s also the question of price. Sanofi and Novo are locked in a battle in the U.S., forcing each other to offer insurers bigger rebates. In Europe, where Lantus just lost patent protection, it’s a copycat version introduced by Lilly that’s creating pressure on prices that even Novo says it can feel. The Lilly copy cost 15 percent less than the original when it was introduced in the U.K. in August". I still believe that Sanofi wanted Afrezza but Al wouldn't agree on the price. They could have lowered the price of Afrezza, improved the insurance tier and had the most novel treatment in diabetes care to come down the road ever. But instead they deep sixed it? Not very smart in my mind and I think they still want it. I guess we'll see. |
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?) clue...
