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Post by bill on Dec 4, 2015 11:12:38 GMT -5
I created the following post on YMB. It's an abbreviated version of the one I posted in the Time to Go Long thread. It seems to have gotten some good play there, so here's a link and the original text... tinyurl.com/gshrzbgSuppose SNY realized how effective Afrezza was back in the summer and that Al was right, all along. Suppose SNY then decided to place a premium price on it to help with future global pricing even though it would hamper insurance coverage and US sales in 2015--the results of which we've clearly seen. Suppose SNY planned on using the results from the two studies and the early adopters that are meeting in San Diego this weekend to create a full launch, improve insurance for 2016, and apply for better labeling in US and beyond--we are starting to see hints of improved insurance coverage. Suppose MNKD knew all this, but could only say they were happy with SNY, were pleased that SNY had significantly increased their marketing budget, thought SNY had a solid marketing plan, and that SNY was all over improving insurance coverage. Suppose the shorts knew that SNY and MNKD were going to be silent on all this until at least December. If the above is true then it's no wonder the shorts have been having a field day with MNKD's stock. However, I suspect SNY's true intentions will shortly be known. Of course, the above is still nothing more than guesses...
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Post by mnkdnut on Dec 4, 2015 16:29:24 GMT -5
To enable a launch worthy of generating exponential growth in scripts, we'll need to document clinical proof of Afrezza's benefits. Early documented patient experiences and the 2 recent "studies" (really just homework from FDA to help provide better guidance on dosing) fall far short of the bar set for such proof. These will likely not move the needle on insurance reimbursement or allow advertising to claim superior efficacy. Too see what we need to do both, here's an example from Regeneron on what was done for Praluent: newsroom.regeneron.com/releasedetail.cfm?ReleaseID=901604A published (or publishable) controlled, randomized, blinded clinical trial done under Good Clinical Practices (GCP) with sample sizes that allow statistical confidence IS where the bar is set these days for clinical proof. As we saw from the FDA Trial data, unless the clinical trial is designed to really show Afrezza's benefits, you can end up with results that just show non-inferiority - which does not help convince anyone to try something new with big black box warnings. I'm hoping (there's that word again) that SNY is using this weekend in San Diego to devise a formal clinical trial that will provide that proof (a la Praluent's) once and for all. The real-world experience is now there to do that. IMO, the turning point for MNKD is when such a trial is announced - well, probably when it's finished, but I'll go with announced. Until then, all the DTC advertising is just building awareness for a product not well accepted by insurance or physicians, and can say nothing about clinical benefits while saying everything about risks. I'm sure SNY is aware of this, and that's why I have trouble believing they are really committed until they announce such a trial. With all the distractions this year of a new CEO and the restructuring of their diabetes business, maybe it's just taking them this long to build concensus on what their Afrezza strategy is.
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Post by EveningOfTheDay on Dec 4, 2015 17:23:49 GMT -5
To enable a launch worthy of generating exponential growth in scripts, we'll need to document clinical proof of Afrezza's benefits. Early documented patient experiences and the 2 recent "studies" (really just homework from FDA to help provide better guidance on dosing) fall far short of the bar set for such proof. These will likely not move the needle on insurance reimbursement or allow advertising to claim superior efficacy. Too see what we need to do both, here's an example from Regeneron on what was done for Praluent: newsroom.regeneron.com/releasedetail.cfm?ReleaseID=901604A published (or publishable) controlled, randomized, blinded clinical trial done under Good Clinical Practices (GCP) with sample sizes that allow statistical confidence IS where the bar is set these days for clinical proof. As we saw from the FDA Trial data, unless the clinical trial is designed to really show Afrezza's benefits, you can end up with results that just show non-inferiority - which does not help convince anyone to try something new with big black box warnings. I'm hoping (there's that word again) that SNY is using this weekend in San Diego to devise a formal clinical trial that will provide that proof (a la Praluent's) once and for all. The real-world experience is now there to do that. IMO, the turning point for MNKD is when such a trial is announced - well, probably when it's finished, but I'll go with announced. Until then, all the DTC advertising is just building awareness for a product not well accepted by insurance or physicians, and can say nothing about clinical benefits while saying everything about risks. I'm sure SNY is aware of this, and that's why I have trouble believing they are really committed until they announce such a trial. With all the distractions this year of a new CEO and the restructuring of their diabetes business, maybe it's just taking them this long to build concensus on what their Afrezza strategy is. This is a great post. One that focuses on what is happening without looking for mysterious fitting pieces. I just have a question, would you care to guess how long such a trial could take? Would it only take a few months to get results, as it seems it has been for many of the early adopters or would it take considerably longer. Mahalo Nui Loa.
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Post by stevil on Dec 4, 2015 18:32:44 GMT -5
I created the following post on YMB. It's an abbreviated version of the one I posted in the Time to Go Long thread. It seems to have gotten some good play there, so here's a link and the original text... tinyurl.com/gshrzbgSuppose SNY realized how effective Afrezza was back in the summer and that Al was right, all along. Suppose SNY then decided to place a premium price on it to help with future global pricing even though it would hamper insurance coverage and US sales in 2015--the results of which we've clearly seen. Suppose SNY planned on using the results from the two studies and the early adopters that are meeting in San Diego this weekend to create a full launch, improve insurance for 2016, and apply for better labeling in US and beyond--we are starting to see hints of improved insurance coverage. Suppose MNKD knew all this, but could only say they were happy with SNY, were pleased that SNY had significantly increased their marketing budget, thought SNY had a solid marketing plan, and that SNY was all over improving insurance coverage. Suppose the shorts knew that SNY and MNKD were going to be silent on all this until at least December. If the above is true then it's no wonder the shorts have been having a field day with MNKD's stock. However, I suspect SNY's true intentions will shortly be known. Of course, the above is still nothing more than guesses... Just to poke a few holes... Here are a few things off the top of my head that don't disprove, but leave me scratching my head if what you said above is true. Why did Hakan quit/get fired? It's rare to be so involved and then just disappear. I guess Matt was doing most of the talking and was the face of the company for the most part anyway, but if things were rosy, why did Al resume CEO? If all the dominoes were in place, why isn't a successor already appointed? Next, why did Matt say "we're not there yet" after being so optimistic the prior CC? Sure, you could say that he knew about a deal and was amped up at the time of the CC, but then he overcompensated on the next one by admitting he made a mistake with the "embarrassment of riches" comment. Then, the rushed and disorganized presentations (could have been due to the technical difficulties). Followed then by the "we're behind schedule from where we expected to be at this time". What you're proposing sounds like a purposeful, methodical plan. While it's still possible that you're right, I'd contend that the events that have transpired over the past 6 months don't point to a purposeful, methodical plan being executed. What I see is MNKD doing everything they can- i.e. opening up the 3rd line and then having to wait on their partner to uphold their end of the deal. I'm pretty sure a milestone payment was attached to that line, so that may have been the incentive to complete it so quickly, but all the evidence I see show SNY and MNKD being out of sync with each other. Sorry, didn't complete that thought. Why would MNKD rush so quickly to open up a 3rd line just to have it sit for 6+ months? It seemed like they were motivated and excited about a near term explosion, just based off the energy that seemed to come out after approval. On top of that, I still can't understand why SNY wouldn't also then buy in to MNKD so they didn't have to hurt their future potential by laying off so many of their R&D folk. SNY would want a strong partner to keep pumping out more drugs for them to partner on. I know there are some here that think MNKD may be stopping SNY from buying in, but really, would you rather lay off half the workforce rather than allowing a (trusted) partner to invest only 5% into your company? Things just don't add up to this... but I guess it's still possible. SNY may just be playing the bully and not caring at all about being a good partner to MNKD. They probably figure they'll get theirs either way.
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Post by stevil on Dec 4, 2015 18:41:36 GMT -5
There may not be many here who believe me, and I guess I don't blame them, but I'm not here to try to quell any optimism. In the last week we've gotten word of a top secret meeting in San Diego that may or may not be happening and people went from being doom and gloom to pie in the sky. We need to try to stay a little more even keel and stay rooted in facts.
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Post by figglebird on Dec 4, 2015 18:42:41 GMT -5
Al is prepared and continues to keep them off guard. He has negotiated with purpose - and remains defensible regardless of mkt cap.
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Post by mnkdnut on Dec 4, 2015 18:50:22 GMT -5
To enable a launch worthy of generating exponential growth in scripts, we'll need to document clinical proof of Afrezza's benefits. Early documented patient experiences and the 2 recent "studies" (really just homework from FDA to help provide better guidance on dosing) fall far short of the bar set for such proof. These will likely not move the needle on insurance reimbursement or allow advertising to claim superior efficacy. Too see what we need to do both, here's an example from Regeneron on what was done for Praluent: newsroom.regeneron.com/releasedetail.cfm?ReleaseID=901604A published (or publishable) controlled, randomized, blinded clinical trial done under Good Clinical Practices (GCP) with sample sizes that allow statistical confidence IS where the bar is set these days for clinical proof. As we saw from the FDA Trial data, unless the clinical trial is designed to really show Afrezza's benefits, you can end up with results that just show non-inferiority - which does not help convince anyone to try something new with big black box warnings. I'm hoping (there's that word again) that SNY is using this weekend in San Diego to devise a formal clinical trial that will provide that proof (a la Praluent's) once and for all. The real-world experience is now there to do that. IMO, the turning point for MNKD is when such a trial is announced - well, probably when it's finished, but I'll go with announced. Until then, all the DTC advertising is just building awareness for a product not well accepted by insurance or physicians, and can say nothing about clinical benefits while saying everything about risks. I'm sure SNY is aware of this, and that's why I have trouble believing they are really committed until they announce such a trial. With all the distractions this year of a new CEO and the restructuring of their diabetes business, maybe it's just taking them this long to build concensus on what their Afrezza strategy is. This is a great post. One that focuses on what is happening without looking for mysterious fitting pieces. I just have a question, would you care to guess how long such a trial could take? Would it only take a few months to get results, as it seems it has been for many of the early adopters or would it take considerably longer. Mahalo Nui Loa. Hi EOD, first I'd say you'd need 2 trial designs, one for for Type I and one for Type IIs. Just my guesses here, but each trial should have sample sizes at least in the hundreds per arm. To make a case for A1C reduction, I'd guess you'd need a minimum of 9 or 12 months of follow-up to show you've reduced A1C beyond the control group and sustained it. It should also demonstrate lower incidence of hypos, less weight gain or more weight loss, and lower visits to the ER. The longer the follow-up, the better chance of showing such outcomes with statistical confidence. Besides follow-up time, you'd have to factor in the time it takes to sign-up trial centers (each involving a contract negotiation) and the time to recruit, qualify and enroll the patients. So, I'd say we're talking about a couple of years, nominally, from saying "go" to completion of data collection. Data analysis and writing it up takes another 6+ months. Getting it published by a reputable Journal another 6-12 months. However, SNY would probably start getting benefit from it as soon as the data could be shared privately with FDA and insurance companies - in parallel with Journal submission. A'ole pilikia.
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Post by EveningOfTheDay on Dec 4, 2015 18:52:31 GMT -5
Al is prepared and continues to keep them off guard. It might be a little late in the game for this kind of statement, don't you think?
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Post by bill on Dec 4, 2015 19:05:01 GMT -5
stevil I don't disagree with most of the points you're raising. My explanation for what might have been going on wasn't intended to imply that MNKD and SNY were on the same page regarding my suppositions. In fact, just the opposite. I think MNKD had to figure out what SNY was up to on their own as well, probably between or at the JAC meetings. They may have even gotten partial or misleading information from their SNY representatives since I suspect there was less than unanimity even within SNY about how they were going to proceed. I suspect a lot of the confusion we've seen on our end reflects uncertainty within both the MNKD and SNY camps. My best guess is that SNY was hedging their bets about which way they were going to jump until sometime past mid-year. All options were being kept alive. I suspect that the results of the two studies and the data from the early adopters allowed SNY to build consensus within their own team to expand Afrezza into a full global launch versus just terminating the agreement. It probably didn't hurt Afrezza's position when SNY found out that Toujeo wasn't going to do all that well by itself as the Lantus successor, and then the Genzyme lawsuit occurred which made it more challenging to simply terminate the MNKD partnership. With regards to Hakan. I don't have any more information than the rest of you, but since he was the face of MNKD for all things TS I'm guessing something TS-related caused the rift. I believe that either he was trying to close a partnership under terms that Al and the BOD wouldn't accept, or he expected to close a deal under terms endorsed by Al and BOD that he thought would be acceptable to the partner, but weren't. In either case, he may have gotten sufficiently frustrated that he decided he could no longer be effective as CEO. He may well have lost all credibility with one side or the other as this all unfolded in real-time. We may never know.
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Post by gamblerjag on Dec 4, 2015 19:06:12 GMT -5
Interesting thought.. We all know Al has a difficult time keeping things close to the vest... He has been very very very quiet.. I think something big will happen in the next two months though I have no idea what..... it's just been tooooooo quiet.... for too long.... Heck, there has been no statement since press release from Al. Al may have one of those dog collars on that when he is about to speak.. he gets buzzed...
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Post by stevil on Dec 4, 2015 19:18:13 GMT -5
Ugh, here I go again with the downer post haha. Oh well... someone has to I guess. I'll be that guy for now.
It's just as likely, if not more so, that the reason it's been so quiet is because nothing is happening...
I actually think with the extended explanation that I'm with Bill.
I do think SNY was multitasking and keeping options open. It makes sense to. It also may explain MNKD's frustration with SNY putzing around while they're ready to hit the ground running. SNY has MNKD locked in for now, so it makes sense that they can do whatever they want. If this scenario is valid, it eases my frustration with management because it would imply that SNY has not been forthcoming in their communication. SNY may have projected a certain plan that got them excited, then put Afrezza on the backburner, leaving Matt and Hakan with nothing to say other than "that's SNY's responsibility". That's about the most PC comment they can make. You don't bite the hand that feeds you. I'm inclined to believe that SNY has MNKD by the balls right now and there's little we can do about it than just wait and hope SNY decides to get serious.
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Post by jeremg on Dec 4, 2015 19:21:30 GMT -5
Ugh, here I go again with the downer post haha. Oh well... someone has to I guess. I'll be that guy for now. It's just as likely, if not more so, that the reason it's been so quiet is because nothing is happening...Horses and Zebras, glad to see someone else isn't hallucinating Zebras.
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Post by mssciguy on Dec 4, 2015 19:30:31 GMT -5
Interesting thought.. We all know Al has a difficult time keeping things close to the vest... He has been very very very quiet.. I think something big will happen in the next two months though I have no idea what..... it's just been tooooooo quiet.... for too long.... Heck, there has been no statement since press release from Al. Al may have one of those dog collars on that when he is about to speak.. he gets buzzed... yeah the silence is deafening. The SNY/MNKD collaboration might as well be a Google X lab project (and if it was, we wouldn't know). Maybe it's better this way. Goldman Sachs has information sources everywhere, and then advises hedge funds.. they are front and center and invisible in all this.
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Post by EveningOfTheDay on Dec 4, 2015 19:34:01 GMT -5
What about this for some play suppose, 1.- Mannkind was in talks with Sanofi from way back, before the second CRL was given by the FDA. 2.- After the CRL, Sanofi wanted to see an approval before a commitment. 3.- Mannkind got the approval and Sanofi signed the deal 4.- Unfortunately for us, Sanofi got rid of the visionary CEO, Viehbacher, that saw real potential on Afrezza and Technosphere. 5.- Brandicourt decides to play it safe from day one, especially having seen what happen to his predecessor. 6.- Mannkind is assured that the deal is still good, but slowly realizes of reality. 7.- Brandicourt focuses on Toujeo, theoretically a much safer bet, even if in retrospect it was the wrong thing to do. 8.- Brandicourt has set us back anywhere between 12 to 18 months in the introductions of Afrezza, if not more. 9.- Mannkind finally catches up with reality and is struggling to figure out how to move forward. First steep get rid of CEO that was never supposed to face the current situation. 10.- Now we really need to start working about what other new technologies might come along that might present a challenge to TS. i.e. www.oramed.com/oramed-signs-up-to-50-million-licensing-and-investment-agreements-for-oral-insulin-capsule-in-china/None of this makes me happy, but it rings true a lot more than all the fanfare and speculation of Mr. Mann having everybody where he always wanted them before he unleashes hell to his enemies.
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Post by mssciguy on Dec 4, 2015 19:36:33 GMT -5
What about this for some play suppose, 1.- Mannkind was in talks with Sanofi from way back, before the second CRL was given by the FDA. 2.- After the CRL, Sanofi wanted to see an approval before a commitment. 3.- Mannkind got the approval and Sanofi signed the deal 4.- Unfortunately for us, Sanofi got rid of the visionary CEO, Viehbacher, that saw real potential on Afrezza and Technosphere. 5.- Brandicourt decides to play it safe from day one, especially having seen what happen to his predecessor. 6.- Mannkind is assured that the deal is still good, but slowly realizes of reality. 7.- Brandicourt focuses on Toujeo, theoretically a much safer bet, even if in retrospect it was the wrong thing to do. 8.- Brandicourt has set us back anywhere between 12 to 18 months in the introductions of Afrezza, if not more. 9.- Mannkind finally catches up with reality and is struggling to figure out how to move forward. First steep get rid of CEO that was never supposed to face the current situation. 10.- Now we really need to start working about what other new technologies might come along that might present a challenge to TS. i.e. www.oramed.com/oramed-signs-up-to-50-million-licensing-and-investment-agreements-for-oral-insulin-capsule-in-china/None of this makes me happy, but it rings true a lot more than all the fanfare and speculation of Mr. Mann having everybody where he always wanted them before he unleashes hell to his enemies. Let's not forget another company beating us to the inhaled migraine trials. Seems like someone really dropped the ball at MNKD.
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