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Post by esstan2001 on May 11, 2015 13:59:48 GMT -5
On this board there are accounts of patients who's doctors knew about and have prescribed them Afrezza. Any one interested can go back and find them.
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Post by esstan2001 on May 8, 2015 12:40:07 GMT -5
Today prompts me to write this open letter to Mannkind Management: You all owe a tremendous debt of gratitude to Al Mann for his genius, foresight, perseverance, and financial commitment in driving Afrezza through the FDA hoops to approval... now it is your turn to repay him with an effective, nimble execution that gets Afrezza into the hands of T1/T2 patients in a manner that validates how correct Al Mann was regarding this being a tremendous blockbuster- possibly the greatest selling drug of all time. And it all needs to be done in a manner that makes it obvious to Al very soon; that is the least you owe to him for the opportunities he had provided to you all. Better sent to Sanofi Management imo. A lot of todays conf call seemed to stop just short of saying Sanofi has screwed up the launch thus far Well... to yours and Savzak's point, yes- you do have a point here. Sanofi bears almost all the responsibility for where we are. (BTW, I do believe this has always been characterized as a controlled launch by both partners... they certainly could have messaged their surprise at the slow uptake better given this). I am hoping that Mannkind management implores Sanofi to do more, or give permission to say more about any corrective actions / plans... whatever they can get in time for the annual meeting, to stem any potential further share price declines (the only other foreseeable material thing we have to gauge with is script counts).
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Post by esstan2001 on May 8, 2015 12:07:47 GMT -5
Getting Afrezza into the hands of diabetics is almost entirely in the hands of SNY. Mostly true however there are certainly things Mannkind can do around the edges to lubricate this a bit. They need to get tighter with Sanofi on this joint operations thing; they can respectfully exert pressure where appropriate as I am sure Sanofi sees the position they are in as a result of where the roll out is (I am not saying this is anything near disaster; but Mannkind needs to demonstrate they are on top of things and in command as much as can be made visible) The next opportunity comes with the annual meeting. I hope to see some signs of improvement- in the messaging, and how they are perceived regarding effective operations (esp in light of the fact that other Technosphere opportunities are now pushed further out than they led us to believe) The importance of this fades as sales ramp up. So, they can worry less about looking like they've kicked back on their laurels IF things are operating.
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Post by esstan2001 on May 8, 2015 11:55:51 GMT -5
Today prompts me to write this open letter to Mannkind Management:
You all owe a tremendous debt of gratitude to Al Mann for his genius, foresight, perseverance, and financial commitment in driving Afrezza through the FDA hoops to approval... now it is your turn to repay him with an effective, nimble execution that gets Afrezza into the hands of T1/T2 patients in a manner that validates how correct Al Mann was regarding this being a tremendous blockbuster- possibly the greatest selling drug of all time. And it all needs to be done in a manner that makes it obvious to Al very soon; that is the least you owe to him for the opportunities he had provided to you all.
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Post by esstan2001 on May 8, 2015 11:26:24 GMT -5
I am now just listening to the call and can yet figure out why ShoutBox was so negative? Management is simply being honest... I hope my criticism of the conf presentation in chat today is not construed as being the opinion of a short. I'm a red investor, I only pipe in here at proboards when i think i can add to the discussion at hand. Being a person who does pr as a part of his profession, I know when it is time to just be a coo, a ceo, a cfo, a scientist, etc..and leave the brunt of the message communication to the experts. My only criticism of the mnkd administration is that it is time for them to realize that at this stage the pr matters as much as the product. They were being honest, at least i think they were but. ..their message was overall unconfident, sometimes indeterminate, and therefore open to interpretation. This should not be case any longer. I sent Matt an email on their messaging (also covering much of what sloppy said below). They need to deliver in a confident, issues well understood, being addressed, and in command manner. And when they deviate greatly from expectations they set up (now 12-18 months for a technosphere partnering) they had better present a good / strategic reason (like we will be able to secure greater value in the deal for shareholders after Afrezza validation or some such nonsense)
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Post by esstan2001 on Apr 30, 2015 15:53:48 GMT -5
MannKind Corp. (NASDAQ: MNKD) dropped about 7.6% on Thursday to post a new 52-week low of $4.23 after closing at $4.58 on Wednesday. The stock’s 52-week high is $11.48. Share volume was about 70% above the daily average of around 5.4 million shares traded. The company’s Afrezza drug continues to see declining sales.
Read more: The 52-Week Low Club for Thursday - Nokia (NYSE:NOK) - 24/7 Wall St. 247wallst.com/investing/2015/04/30/the-52-week-low-club-for-thursday-34/#ixzz3YpO8ienkFollow us: @247wallst on Twitter | 247wallst on Facebook What garbage innuendo.
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Post by esstan2001 on Apr 29, 2015 6:58:18 GMT -5
Great points, poorneil... I remember Preston(?) Tucker made a fast car too.
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Post by esstan2001 on Apr 25, 2015 8:27:39 GMT -5
I agree with everything you wrote but I think you may've missed my point. I wasn't criticizing him for selling 73k shares. The point of my post was to address the sentiment of long investors given the totality of our current circumstances. The sale was his right, I just think it's unfortunate for longs who would like to see their accounts stop losing substantial value every day. savak in the end, it really amounts to noise about something not in our control. Take the long view. We are either going to be right based on our conviction, or wrong. Keep the near term focus on the real data to keep the assessment accurate. ...and I don't think I'm telling you anything new that you don't do already.
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Post by esstan2001 on Apr 22, 2015 21:12:08 GMT -5
So how do you explain that Toujeo willl have 10x more scripts in the same time frame? Well...it is a slightly improved version of Sanofi's Lantus that they sell over a billion of, sales channels / existing patient base already there for this upgraded replacement. Almost no educating or sales effort required. Use similar as Lantus. yahoo. The place for you.
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Post by esstan2001 on Apr 10, 2015 8:30:48 GMT -5
Pfizer indicated that the drug could be the "first non-injectable" treatment for diabetes on the market and JP Morgan analyst Chris Shibutani expects it to have annual sales of more than $1.1 billion by 2009, Bloomberg reports. Exubera was recently recommended for approval in the US and the EU. An FDA decision on the drug, which was delayed for three months as the agency sought more data, is expected later in January. Nice example of an analyst being 'off slightly' on the numbers. Tempted to look up if he's still an analyst. But he's probably risen to executive for all i know..though perhaps blown out during the 08-09 bloodbath But what is interesting is that his model had over $1 billion as revenue about 3 years out; along the same lines as what we see from analysts here.
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Post by esstan2001 on Apr 8, 2015 6:26:57 GMT -5
credit to lakers_w over on the yahooey board
Must Read: Phase 3C - Market Approval and Soft Launch Phase 3C – Market Approval and the Soft Launch
For years we have followed the logical progression of products through clinical trials and into launch and commercialization. The approval of an NDA is also known as “marketing approval” and is usually followed quickly by launch—also known as commercialization. Launches are usually treated as an event, often signaled by a “launch meeting” in which we fire up the troops, provide some high-level training, and rally ‘round the flag. Lately, however, the launch process for many products seems to have sputtered, with the excitement inside the launching company unmatched in the marketplace. Many sales teams feel rejected when the market doesn’t jump to embrace the product, and these same salespeople often feel let down by their company and their colleagues in marketing. True, there have always been failures in pharmaceutical markets, but why is it becoming so much more common? The simple answer is that the market has changed.
Over the past several years three forces have aligned to make the successful commercialization of new pharmaceuticals more difficult: the crowding of therapeutic categories by more new (and not so new) products, the rise of third-party payers, and some spectacular product failures. These forces are not independent: they interact and each, in fact, magnifies the power of the other.
CROWDED CATEGORIES
Whether we blame “me-too” drugs, the lack of innovation and inspiration, or whatever, there is no denying that most therapeutic categories are becoming more crowded. This is not new; in fact I wrote a paper about it in 1995.1 At that time, though, new competitors were often likely to offer real improvements, either in efficacy or tolerability, and were readily accepted by the market. What is new now is that we have more products that do not offer substantial new benefits; they simply provide more options. The value of Zantac over Tagamet was fairly easy to establish (I know this is ancient history to many but the point is important), and the value of Lipitor over Zocor was enough (at that time) to convince more doctors to prescribe the newer drug. But as we look to our crowded categories today, it is often much more difficult to identify the meaningful differences among products—certainly, product teams and their agencies will attempt to point out any differences, but in most cases the market does not appear to appreciate them.
I’ve often talked about understanding market opportunity in terms of “receptor sites,” as in, “Are there enough open receptor sites in the market for your product, or are they already occupied firmly by another product?” We can see in the listing of NDA approvals that there are more “repurposed” and reformulated drugs and fewer priority reviews (other than in oncology), which means that fewer truly innovative medicines are coming to the market. This isn’t a criticism of pharma R&D, just an acknowledgement that it is less common—and perhaps more difficult—to discover and develop truly innovative and needed new drugs. Although your new ADHD product (or antihypertensive or other category) may be special to you, if the market doesn’t see the product fitting a specific unmet need it is unlikely that there will be much use. In many categories, it appears that new products are not offering new value, but often only offering another choice. That offering of another choice—without new value—shifts power from the marketer to the customer, which brings us to the next force.
THE RISE OF THE PAYER
For more than 20 years, I have heard people talking about how powerful payers are becoming, and for close to 20 years my response has been: “Oh yeah, when?” I now have an answer to that question: “Right about now, depending on the category.” Payers are using their muscle and influence in markets as never before, but they really couldn’t do this until they were provided with more products that allow them to play one against the other without denying physicians the ability to treat patients effectively. The inevitable result of a crowded category without substantial and meaningful differentiation is price competition, and payers know this and use it to their advantage.
The first stage of management is, in fact, non-management. At launch, virtually all new products will either be placed on third tier, a co-insurance tier, or be not covered. In over 99% of cases, this is a policy decision that has nothing to do with the product or its price. This allows the payers to evaluate the product and its use before making a formulary decision—but it also acts to slow the adoption of the product. Medicare Part D requires a “review” within 90 days of commercialization, but that “review” can be as simple as a decision to keep the product on a high co-pay tier for another year before making any other decisions. If you are fortunate enough to be launching a new product that meets a gaping unmet need in a critical area, your product may be reviewed fully and more quickly, but that’s the exception not the rule.
In my conversations with payers, which occur at least once per week, the one constant theme in the “rule of management” is that when there are four or more agents in a category, it is a target for management, and when there is at least one generic in the mix, it becomes a very attractive target. “Management,” in this case, may range from simply placing some products on higher or lower co-pay tiers to the imposition of prior authorizations or step therapy (also called “generics first”). Many categories (such as contraceptives) are “managed” in this manner: some call it a “first and third” approach, with all generics on first tier and all brands on third. Whatever the form of management, what makes it possible is the presence of similar competitors—payers love “me-too” drugs because they help them do their job! Payers, in general, are feeling and acting more powerful because so many categories have so many therapeutic choices. In a category with several similar agents, physicians are unlikely to fight for one product over another, and this phenomenon builds on itself because the more “power” physicians give up, in terms of product choice, the more they tend to be willing to give up in the future, as long as patients aren’t harmed.
Thus more choices for the physician has resulted in less autonomy for the physician and more choices being made for them by payers—regardless of the effect on your product and your plans, you must at least appreciate the irony!
PRODUCT FAILURES
There is at least one more reason for physicians to be slow in adopting new drugs. Without going into detail, in recent years several major products have been associated with potentially dangerous sideeffects, and many have been withdrawn from the market. We’ve noticed an increased reluctance among primary care physicians to try many new chemical entities (NCEs), because they were unfamiliar with them and chose to let others gain experience before taking a chance on new drugs. This, too, has helped payers to gain more confidence: they determine their need to cover a drug, in part, by assessing physician demand, and have justified their delays in reviewing new products by their need to assess physician uptake. With many physicians unwilling to risk an early adoption of NCEs, payers either deny coverage for many new drugs or place them on their highest co-pay tier—both actions reduce the value of a drug to the physician because they result in higher patient costs. With the availability of so many good—or at least adequate— therapeutic choices for so many disorders (e.g. fewer “receptor sites” in the market), there is less urgency within the market to adopt new drugs. Not that this is true in every case, but for most new drugs there is little urgency within the market to adopt new therapies because there are so many good options.
THE SOFT LAUNCH
NDA approval, also called “marketing approval,” once marked the beginning of the formal launch of a product, its “birth” if you will. Today “marketing approval” is fine, but unless the new product is a significant breakthrough that will find a ready market just waiting for it, your new offering will likely require “market approval,” by way of formulary coverage decisions and some level of trial and approval by practicing physicians, before it can truly be considered launched. Think of this as an “incubation period.” NDA approval, rather than signifying the end of the pre-launch process, now may signify the beginning of a new final stage of the pre-launch process, the “soft launch.” During this stage, you fine-tune your approaches to the various market participants, help them understand your product and have them help you understand the way they see it, and then finalize your actual marketing plans. This will affect forecasts, budgets, and virtually every aspect of marketing planning, and those who don’t build these new forces into their plans are headed for some big disappointments in the near future. Less
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Post by esstan2001 on Apr 7, 2015 13:39:50 GMT -5
EMA data is controlled data and Afrezza trials have been conducted in Europe for quite some time. The FDA certainly does make use of EMA data, especially when reviewing a drug that was approved overseas first. Regarding Afrezza, I recall reading a few months ago that all but two Afrezza trials have been completed. The reason why Sanofi has "delayed" applying for centralized authorization to market Afrezza throughout Europe is totally incomprehensible and, frankly, the mystery fuels much of the speculation behind the rumor that Sanofi is planning to buy all rights to Afrezza. Back to the point, however. It has been a few years since I reviewed the complete EMA/EMEA approval process, but my understanding is that in Europe the trials are conducted and then application is made for the EMA review committee to review the trial and supporting data. This review has to be completed in a maximum of 210 days (7 months) and then is submitted to the approving committee, which takes another 30-45 days to finalize marketing approval. The slower-than-anticipated Afrezza rollout in the U.S. (planned, I assume) seems to be the primary reason for the delay, and Sanofi may not consider it a "delay" at all. We all know that it's no longer Toujeo that's responsible for holding up application in Europe, as Toujeo has been approved in both Europe and the USA. Besides the "usual suspects", such as gathering anecdotal data from new patients and/or the educating of physicians/endos, I strongly suspect that Sanofi is attempting to get the label fixed before the major marketing push. ...if there's any reason to be hush-hush, re-labeling would be a BIG one. Assuming that one or more of the competing pharmaceutical companies is behind all this negativism and so-called "market corruption", they'd go ballistic if Afrezza was re-labeled as a having a distinct advantage over their own drugs. So the competitors may also be pressuring the FDA and providing reasons why the label should NOT be expanded. We're talking $billions in revenue at stake in this debate over a potentially disruptive new diabetes treatment option. In speculating like this, I'm simply trying to think ahead by identifying what are the most important things that need to be taken care of. That label is top of the list - IMHO. Essentially agree with everything you pose. Yes there were trials in the EU / even Russia at some point; that data was all part of the US FDA submission as best as I recall. The key thing that you bring out (that I was unaware) is that there may still be 2 trials underway, and what protocol design they were set to follow. Were / are the endpoints identical to the trials used for approval? What sway would SNY (and those that have something to lose) have on FDA / EMA, allowing them to be modified mid-stream to add more endpoints... I kept operating under the assumption that new trials would be set up and run to expand the label; anything that can be done to accelerate this would certainly be a game changer not factored into the current price.
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Post by esstan2001 on Apr 7, 2015 11:52:36 GMT -5
...and Sanofi has data from the current European Afrezza trials that can be submitted to the FDA. Finally, discussions of this sort between Sanofi and the FDA do not require disclosure so, of course, I have no way to validate my suspicions. Is this a known fact that you slipped into your wishful speculation? (don't get me wrong, I'm on board- my hopes and dreams too) Is anyone aware of any study activity that has commenced that is looking at these other factors beyond A1C that would benefit the label? I do not expect the FDA to react to anything other than a controlled trial; no anecdotal / social media data would be accepted AFAIK.
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Post by esstan2001 on Apr 7, 2015 7:29:56 GMT -5
based on the contract between mnkd and sny, does mnkd have any legal recourse if sny fails to market Afrezza in a reasonable manor ? cant believe al mann would not have required some agreed upon standard. if there is some langue in agreement what is it ? is it being meet ? If Mannkind is not happy they can initiate dissolution of the partnership. So can Sanofi. IMO, we are not going there, not even close. Strongly agree with jpg that at this stage it is all about mind share and positive social media. What is excellent is the fact that there is hardly any negative feedback from the diabetic community once they get past the learning curve... matter of fact that is the primary criticism of Afrezza so far- getting the dose and timing right for each person. I am sure Saanofi is monitoring this and factoring it into trials design and the next stages of this roll out. IMO, this is executing to a plan. Someone else had highlighted how Afresa is going to have to contribute to the revenue hole left behind Lantus going off patent, once generics arrive on the scene. And I also do not buy that the reps dropping Afrezza in favor of Toujeo efforts- they do not compete at all. They complement. Ergo, whatever Veilbacher, the new CEO, and the Chairman had been saying all along about co-promotion efforts. Of course if you were a rep, you would push both- more commission. We are all just being impatient nervous nellys looking at 8-9 weeks of data. 6 months from now, different story. And I will bet it will be at that point. :-)
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Post by esstan2001 on Apr 6, 2015 9:05:47 GMT -5
Noting the vacuum here this AM, I actually went over to the yahoo board for the first time in ages- and strangely found a few worthwhile posts... go figure! Now I am actually worried that either the Earth may spin off it's axis, or the poles will change polarity :-)
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