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JLS Monday, 08/17/15 06:33:07 PM
Re: TREND1 post# 14048
Post # of 14052
Do you know ...
Drugs applied directly to the skin bypass the liver.
http://tinyurl.com/nu4364o
http://tinyurl.com/pt62mef
What about Omnipod? It's a type of patch, and a lot more -- it has brains.
http://tinyurl.com/og23fh4
And last but not least ...
As for huge breakthroughs ... Diabetics could soon produce their own insulin. Maybe this is why A. Man is not in such a hurry to put more money into MannKind.
http://tinyurl.com/o44c24v Just a little teaser below:
In a study published in the journal Cell, a team of Harvard Researchers transformed stem cells - which have the potential to develop into a range of different cell types - into beta cells, which produce insulin to help regulate blood sugar. These cells were then inserted into diabetic mice, whose blood sugar was observed over a few months.
Results showed that the manipulated cells functioned as normal beta cells and were not attacked by the immune system, which is what usually happens in diabetics. The cells had a noticeably fine-tuned response to sugar levels in the blood, and six months later, the mice’s blood sugar remained under control. This is a huge breakthrough that could help free diabetics from daily insulin injections.
Okay kids, I gotta go do some work. Just make sure you do your due diligence and don't put too much money in the wrong place (or in just one place).
JLS Monday, 08/17/15 04:14:40 PM
Re: TREND1 post# 14045
Post # of 14048
Can you say Flozins?
New diabetes drugs -- bypass liver
Been researching that.
"The Arrival of the SGLT2 “Flozins”
Sodium glucose co-transporter-2 (SGLT2) inhibitors are different from most type 2 drugs. Rather than increase insulin production or decrease glucose production, SGLT2s bypass the liver and pancreas and work on the kidneys. In short, the drugs reduce the reabsorption of glucose from the kidneys by making them shunt the glucose into the urinary tract.
The beneficial effects of doing so include negligible risk of hypoglycemia, weight loss, and reduced A1c.
SGLT2 drugs, sometimes referred to as “flozins” because of the last syllables in their name, include canagliflozin (“Invokana,” Johnson & Johnson), dapagliflozin (AstraZeneca and Bristol-Myers Squibb), and empagliflozin (Boehringer Ingelheim and Eli Lilly and Company)."
http://tinyurl.com/py26447
An exhaustive look at diabetes drugs in the pipeline is available at http://tinyurl.com/o626fq2
The PDF, aimed at professionals, is heavy on scientific and medical terminology, but offers useful information to the lay reader.
VALENCIA, Calif., Aug. 4, 2015 (GLOBE NEWSWIRE) -- MannKind Corporation (MNKD) will release its 2015 second quarter financial results on Monday, August 10, 2015 and its management will host a conference call to discuss the second quarter financial results and other Company developments at 9:00 AM (Eastern Time) on August 10, 2015.
Presenting from the Company will be its Chief Executive Officer, Hakan Edstrom and Chief Financial Officer, Matthew Pfeffer.
To participate in the live call by telephone, please dial (800) 708-4540 or (847) 619-6397 and use the participant passcode: 3859 3128. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at http://www.mannkindcorp.com.
FIRST POST robert sacher 07/28/15
robert sacher Tuesday, 07/28/15 11:55:28 PM
Re: JLS post# 13519
Post # of 13525
I am the author of the article, MannKind's Afrezza May Reach Larger Diabetic Population Than Previously Considered.
Here is a link where readers can read the entire article along with comments:
http://seekingalpha.com/article/3364395-mannkinds-afrezza-may-reach-larger-diabetic-population-than-previously-considered?auth_param=2hisp:1arfccv:171e08b5b04209f6dc0b21aa2aa8a0f2&uprof=44
There are many studies which have shown that the majority of people, not only diabetics, are needle averse and if given an opportunity to use a painless way of receiving medication, they would choose the alternative therapy.
I quote four studies in the article.
I invite readers to also read other articles I have written about MannKind here:
http://seekingalpha.com/author/robert-sacher/articles
Best wishes,
RS
first post Cave In Temptor 01/29/14
Cave In Temptor Wednesday, 01/29/14 08:06:28 AM
Re: martind18 post# 2437
Post # of 13514
Transaction as part of a divorce settlement, says the note.
FIRST POST Phaeton 05/20/14
Phaeton Tuesday, 05/20/14 11:00:20 AM
Re: None
Post # of 13510
Well you had a top officer sell some stock. So why did she get out before the big run up.
I am long and want to buy more but am hopeful for another pull back so I can jump in. 7.68 seems very high in a just a couple of days.
http://www.lulegacy.com/2014/05/19/mannkind-vp-unloads-128323-in-stock-mnkd/
MannKind (NASDAQ:MNKD) VP Diane Palumbo sold 18,176 shares of the company’s stock on the open market in a transaction that occurred on Thursday, May 15th. The stock was sold at an average price of $7.06, for a total value of $128,322.56. Following the sale, the vice president now directly owns 158,858 shares in the company, valued at approximately $1,121,537. The sale was disclosed in a document filed with the Securities & Exchange Commission, which can be accessed through this link.
first post Hypi 05/19/15
Hypi Tuesday, 05/19/15 01:47:45 PM
Re: MrktMovrs post# 11353
Post # of 13509
The stock is so undervalued and should be at a minimum of $10 based upon where we traded prior to the partnership and after approval. MNKD's story has only grown and gotten better, so these levels are a gift to buyers. I think anything under $10 is a solid buy. Shorts doing their best to exit in an orderly fashion without getting steam rolled, but its a stair step move that just keeps on climbing
first post vip1999 02/17/12
vip1999 Friday, 02/17/12 08:15:32 PM
Re: drmoneybags post# 394
Post # of 13507
RISK!
first post kugel 03/28/11
kugel Monday, 03/28/11 03:28:41 PM
Re: TRENDmendous post# 334
Post # of 13507
Looking forward to getting back in one day great product with tremendous health advantages.The FDA will have to pass it.IMHO
first post Denise Chanterelle 03/14/13
Denise Chanterelle Thursday, 03/14/13 09:24:13 AM
Re: primarywatcher post# 634
Post # of 13507
Mahalo for this article. It was very helpful to me. I'm planning to get in very soon here and just waiting for the dust to settle from the recent run up. I see MNKD doing quite well in 2nd half of 2014, possibly sooner. This is a solid investment opportunity. GLTA & Aloha.
FIRST POST conix 01/20/11
conix Thursday, 01/20/11 12:51:48 PM
Re: mlkrborn post# 266
Post # of 13507
MNKD should do a Conference Call soon to answer questions and update shareholders.
I could not resist and bought this morning. I am not going to wait two years to sell, but I think there are plenty of speculators that will buy this up from these lows with more news.
The people who sold are those who, imo, was expecting positive news and wanted a pop in the price to profit. Now it is obvious the short term was not going to happen for them--and they are moving on.
The new guys coming in (or the ones that averaged down) will wait for more news.
That bounce that I am expecting is what I am in for.
then on the convertible debt that comes to in August, the $100 million, can you help us understand what options are on the table there and maybe give us some idea what your plans are for that?
Matt Pfeffer
Well, good news is we have a lot of options. Bad news is with the volatility and the stock and so far that we’ve experienced, currently it makes it harder to choose which one is the best one because it can change from day to day. And as we sit here at this moment and at least the last time I check the price and I did few months ago. I mean, they are in the money. They can just convert or we might want to and just conversationally, just to make them go away and have this not be an issue in people’s minds or we can extend them or stock them out.
There is just a whole host of the things that we can do. People talk about, worry about dilution and so forth. And I have a said couple of times publicly, one thing I can virtually guarantee we won’t do is the marketed secondary offering. That doesn’t mean there might not be some equity components somewhere down the road. It’s not going to be in a way that those shares would be readily made available to somebody who is a short of stock, just hypothetically.
I mean, a convert is still, is really just a matter of when it [Technical Difficulty], does it occur immediately or does it occur when they convert? I think the dilution from these instruments already have been factored in by everybody. So next time, we can do something without issuing more shares then we’d be issuing on to this instrument, I think we will be in good shape.
And I have almost daily talks with different organization and holders of the convert because they are very interested too. Most of the calls I get are from people looking because they like their paper and they want to keep it or some form of it. And so I’ve always said if we can find a way to do it that made sense for the company, we would probably extend it or roll out a bunch of the instrument. When we get closer, we will be able to see which makes more sense.
There is a $25 million milestone.
Matt Pfeffer
That’s a trick one to answer. But it’s good you asked it. So the remaining milestones which totaled some $725 million of milestone are mostly sales-oriented. There are a few that are not. There is a $25 million milestone. It’s more kind of production seems oriented or development based milestones
TV ?
Matt Pfeffer
I’m glad you ask that because I have seen dramatically contradictory information being circulated sometimes from the very same source. So not sure how that happens exactly. Yes, initially, we will be print and web-based for the most part. But the key thing there is initially, we are not moving our TV by any means. In fact, we budget it mainly to gruesome things for TV this year. But it’s not expensive to produce a TV spot. It’s expensive to air the TV spot and I think, Sanofi is wisely leaving options open and seeing how the impacts shakeout for the things they’ve planned initially before they decide how big they go into something like TV or you missed that all, so definitely not ruling out.
MannKind's CEO Presents at Goldman Sachs 36th Annual Global Healthcare Conference (Transcript)
by SA TRANSCRIPTS | JUNE 11, 2015
MannKind Corp. (NASDAQ:MNKD)
Goldman Sachs 36th Annual Global Healthcare Conference Transcript
June 10, 2015 11:40 AM ET
Executives
Hakan Edstrom - Chief Executive Officer
Matt Pfeffer - Chief Financial Officer
Analysts
Jay Olson - Goldman Sachs
Jay Olson
We will get started. It’s my pleasure to welcome Hakan Edstrom, CEO of MannKind; and Matt Pfeffer, CFO of MannKind. And I want to thank you for joining us here today.
Hakan Edstrom
Thank you.
Matt Pfeffer
Thanks.
Jay Olson
So I thought we could start off by talking about ADA, you’ve just come from meeting in Boston. Can you give us some idea of the abstract, I think, there were two AFREZZA abstracts that were presented? What kind of things you are hearing, feedback from doctors about AFREZZA and just sort of overall how did ADA go for MannKind?
Matt Pfeffer
I think we were pleased by the reaction of ADA. I think it was a great opportunity for us. It was obviously very prominently featured in the Sanofi booth, which we are pleased to see. So as it has been commented and I was thrilled because I was coming into the entry hall down the escalator for the first time into the exhibit floor to be met with the 10 by 20 foot AFREZZA sign at the opening of the Sanofi booth. It was pretty encouraging.
But, I think, they track the data and they talked a little bit about it and their diabetes they call which they do traditionally after every ADA, they kind of talk about the data that have been presented. There wasn’t that kind of data on AFREZZA, but they did mentioned a little bit and talked about the reception it was getting and traffic in the booth.
And all I said half of it was traffic in the booth, which was very heavy and up substantially over the prior year was in fact associated with AFREZZA. And I know, Hakan and I both could resist occasionally, hey, you are around and listening in our conversations, and it was very eye opening and very encouraging for both of us.
So their reception was great. The educational session was extremely well-attainted. The semi session, I can only stay for the first two main speakers, as many of you know Al Mann was honored at the banquet that night, so everybody talk to that.
But I think its fine and I could tell, there was not a single open session in whole place and this is a couple thousands seat ball room. So, a lot of interest, a lot of enthusiasm and words clearly getting out there.
Jay Olson
All right. Very good. Now the two abstracts that were presented seem to have been a little bit more safety-oriented? Do you have the impression that some doctors are waiting for additional safety information before prescribing AFREZZA?
Matt Pfeffer
I think it’s more reflective, because there is not a lot of new data available for AFREZZA. So there are some -- some of the data have been announces this. I am not sure who exactly that was. I don’t think that’s associated with that.
But it was pretty much a repeat of things we have done in past. There wasn’t a lot of new news. It did again repeat some of the advantages we have seen in the clinical trials as far as lack of hypoglycemia, weight gain and that sort of thing.
Things that didn’t ultimately make it inflatable but it’s nice to see it revalidate it from the clinical data and as was mentioned by the [indiscernible] at Sanofi and we hope we could get that into print in some preview journals shortly, which will help, because it gets the word there a little better, something that’s medical liaisons can refer to and be more data oriented in their presentation of the product and its advantages.
Jay Olson
Okay. Now just moving on to the script performing, I think that’s the key issue top of mind for most investors? I know that I personally lowered my forecast a couple of times based on lower than expected scripts. They have been running around 300 per week. We look at them every Friday. They are -- again they are lower than what I have forecasted? Can you help us understand what’s going on with the script performance? What kind of things are in place to help turn that around? I know you talked about the spirometry? Are there other steps that can be taken to overcome some of the key hurdles towards getting an AFREZZA script?
Hakan Edstrom
Yeah. I think that initially also the expectations probably looks at the adoption would be say much more rapidly. When it comes to insulin, insulin is a very important drug. So even from, say, patient and doctor point of view education is very critical component.
So that’s why we have focused, one most exclusively and an iconologist in the beginning, because they tend to be the reference point for the practitioner in terms of putting their patient on that.
We also know that iconologists are not necessarily the big prescribers in terms of drug and they tend to have the type 1 patients. And what we see in the data are actually so far if you go to social media that’s a lot of type 1 patient. So very enthusiastic about what they see in terms of their data, particularly they are postprandial because they are may be on continues glucose monitoring so and so forth.
So we knew that an educational process is very important. We need to invest in that one today we want to reach the piece of piece and majority of all target audience which is type 2 patients.
So we are basically invested in that one. We facilitated some of the primary function testing the prior the sessions and if I need that, having established together with Sanofi. What I would call [indiscernible] service, where the reps, the doctors and the nurses can go to say, hey, if I need the primary function that in the area where can I go, where can I find that. So also in terms of [indiscernible] what do we need to do.
So we really try to facilitate the process, because it’s more an administrative challenge than it is a product challenge, because physicians we speak, to the patient we speak to are very, very enthusiastic in regards to the product.
We are now in the process and I now actually met with the Sanofi leadership last week in the process of reallocating some of the efforts to more towards [piece of piece] [ph]. We are increasing the sales force coverage and we are increasing the investment to almost kind of taking to the next level of the threshold, which then will coincide as always also with the direct-to-consumer advertising.
Jay Olson
Great.
Matt Pfeffer
Now Sanofi has been pretty open but initially it was going to be a very focused and targeted much and it has been.
Hakan Edstrom
Yeah.
Matt Pfeffer
But now that you have been equally opened, this is the time to after their respectful interval as they call it. [Indiscernible] had a lot more with the doctors. I mean we still see a lot of surveys, let say, frankly to me because I have been living and breeding AFREZZA for so long. There is an off a lot of doctors who still don’t know about it. But that’s the focus now to change that. I think direct-to-consumer advertising will be a big factor and that which has been now said, we said -- we’ve been saying early third quarter, I think Mr. [indiscernible] had in a few weeks. So I think we tipped his hand and we are talking July and probably early July at that. So we’re right on the brink. I think that will help. This is a product that was made itself to that kind of advertising I believe.
Jay Olson
Can you talk about just in terms of the AFREZZA JV P&L. Where do scripts need to be in order for that JV P&L great season? What kind of run rate are you looking for?
Matt Pfeffer
Yeah. That’s a little further value. It’s becoming very comfortable going in the disclosure because it touches on so many areas. Certainly, they need to be higher than this. That should be surprise to nobody.
But this is a product that’s very sensitive to volume. So these full volumes make a people because markets are not there. But they decrease dramatically rapidly. We view it from our side since we are the manufacturer particularly because we have a big beautiful manufacturing facility ready to produce all types of the product and we need to get some of the fixed cost covered a little more. So we’re clearly not there yet. I had some forecast to say we didn’t get there pretty quickly but beyond that I’m not sure I want to be too open at this point.
Jay Olson
Okay. And then how can you mention sort of a concierge service to get patients into doctor’s offices who can perform spirometry. I think on the last earnings call, you mentioned idea of a low cost effective spirometry test that could potentially be more broadly used. Can you update us on any of those plans in terms of overcoming that initial hurdle to getting the AFREZZA script?
Matt Pfeffer
Yeah. We’ve gotten a few samples from the manufacturing of the device. We basically provided it to Sanofi as an option just to look at. Sanofi also has really a product division, more of a capillary equipment division. So they are working also together with them in terms of looking at what is the doctor looking for because they should hear it’s probably more just with endocrinologist. When you look at the PCPs because they are dealing with people with asthma and other kind of respiratory diseases, they tend to have this piece of equipment. And it is reimbursable. So it’s not like it’s -- you basically have to pay back that was within a couple of months since we have a recent patient population to deal with.
Jay Olson
Okay.
Matt Pfeffer
It was mentioned by at least one of the doctors in one of the educational session where I talked a couple of them as well. It could potentially be an advantage because there is a reimbursement code for spirometry testing. The payback period could potentially be relatively short. The issue is do you have the machine available to you. And then this person that I most recently spoke to, happen to be an endocrinologist. He said yes, he bought one for that reason. I think he said he has paid between $500 and $600. For the pricing of these things, it’s all at the math, depending on whether you really intended to be doing full pulmonary work-ups or if you really just needed to do an FEV1 which is a pretty simple test.
In fact, he said one of the reasons he bought it was because he didn’t want to have to refer his patients out to pulmonology lab where they would probably do a lot more than it’s necessary. They can keep it quite simple and easy for the patient. So we hope to see more and more of that.
Jay Olson
Okay. And you mentioned shifting the physician promotional strategy from focus on endocrinologist, moving out more broadly to PCPs. Are you still focusing on high -- very high subscribers or are you going to go to doctors who haven’t prescribed a lot of insulin and with regard to the patient type, are you targeting type 2 diabetics who are already on insulin or those who are controlled by or not controlled by oral diabetes products who might benefit from insulin with the strategy in terms of the patient?
Matt Pfeffer
The simple answer is kind of all the above. I mean the primary focus is and I think what the greatest benefit will ultimately be is to focus on those who ought to be on insulin because they are failing orals for whatever reason their A1Cs are climbing that are resistant to doing that. And that’s a very right area for we could make a big impact on the patient base.
Additionally, we know that those -- I mean, quite often today when you start insulin, you start with a basal insulin. And it’s hard to keep control. You can see as you arise, your A1C is what proportion is related to basal insulin versus prandial insulin or prandial rises and you see that it kind of shifts to prandial overtime and use can increase the base of those very much anymore or you start risking hypoxia. So you are really intervening with a prandial insulin. Again patients are very resistant to doing that but we think they will be much less resistant to AFREZZA. And I think that’s a lot other strategy Sanofi is working on.
That said, if you go out there and check the social media, the people who are most focal are type 1s because they are finding that they are having dramatic success with the product and they are able to control their glucose excursions much more than they’ve ever been able to do before. And I think the reason you’re seeing that and it makes it appear that it’s more focused on type 1s because they typically have the advantage of having continuous glucose monitoring. So they can see the effects immediately in the first week of using it or first couple of weeks versus a type 2 will typically have to wait a few months and watch their A1Cs slowly decrease.
So type 1s are getting all the play but ultimately we think type 2s for intensification or earlier initiation of insulin is where focus ought to be in and will be.
Jay Olson
Okay.
Matt Pfeffer
And I think we missed a part of your question, you said are we focusing on higher prescription?
Jay Olson
Just going back to sort of it types and numbers of doctors that you are reaching at to?
Matt Pfeffer
Ultimately, obviously, it’s not a rationale thing to do as you go to people who tender right scripts the most and then you expand outwards from there. So right now as Hakan said, mostly focused on entreprenologists and now we are moving more and more into high prescribing PCP as well. So, we are kind of broadening out now.
Once you get, you can’t possibly expect to hit every primary care physician of the country. There is just too many, hundreds of thousands of them and nobody has a sales force that can do that. But you start learning about who has the interest and you can also cover them a great deal with what we keep on direct-to-consumer advertising, but in many cases it is directed doctors as well because where you will often see things, at least, especially in issuing is in the diabetes magazines and those kinds of things where you have the benefit of all the patients but also the doctors.
Jay Olson
So with regard to the number of doctors and number of details that you are calling on through the JV, do you have a specific target in mind and do you have a way of sort of auditing back the number of details?
Hakan Edstrom
Yes. Sanofi is very closely following with a number of metrics in terms of who are the key doctors, how often do they get visited in terms of the reps, also how many visit they expect over the reps during the month. So that gets report to us actually on a weekly basis in conjunction with the sales numbers. So, definitely, we see them keeping us well informed.
Jay Olson
Okay.
Hakan Edstrom
In conjunction to that and that is on what we call the joint AFREZZA committee with Sanofi, which basically at this point is meeting on a monthly basis.
Jay Olson
Okay. And then are the sales reps who are doing these details -- because there is some questions about this. Are they Sanofi sales reps, are they contract sales reps who -- what sort of mix do you have involving AFREZZA?
Matt Pfeffer
You will find a little bit of both. Sanofi, I think is very good at figuring out how do this and they will do a mixture of contract people and their own people for all their products, not just AFREZZA. But it gives them a little more flexibility for kind of redirecting and being responsive quickly. It’s easier to do with reps and have some contract people and frankly the contract organizations are a right source for new recruits, their own sales people. So, yeah, it’s -- they have both and they are normal sales people and some contract people and AFREZZA likely do really, I think all their permits.
Jay Olson
Okay. Let’s talk about the DTC campaign. So, I think there has been a few questions about just in terms of kind of the different components of the campaign, the timing. We’ve heard that initially, it’s going to be focus. It’s going to be print and online. Are we correct to understand that there is no television, or what should we sort of expect to see when the DTC campaign moves on?
Matt Pfeffer
I’m glad you ask that because I have seen dramatically contradictory information being circulated sometimes from the very same source. So not sure how that happens exactly. Yes, initially, we will be print and web-based for the most part. But the key thing there is initially, we are not moving our TV by any means. In fact, we budget it mainly to gruesome things for TV this year. But it’s not expensive to produce a TV spot. It’s expensive to air the TV spot and I think, Sanofi is wisely leaving options open and seeing how the impacts shakeout for the things they’ve planned initially before they decide how big they go into something like TV or you missed that all, so definitely not ruling out.
It’s not true that it’s not being considered because there is a budget mainly allocated for -- one of the advantages of having something like the Joint Afrezza Committee that Hakan talked about is we both have to approve where all the money is being spent. It’s is a joint budget and likewise, it has to come to us for approval of variations in that spend and so forth. So, we are able to keep a close eye on it. I should expect because ultimately, 35% of royalty expense is paid full by us. So, we have a good reason to follow that very closely.
Jay Olson
And can you talk about the strategy behind the DTC campaign? Who were the patients you are targeting and just going back again to, are they type 1 or type 2 diabetics and what sort of is the message that you want to reach out to these patients with?
Hakan Edstrom
Hakan again, certainly it’s type 2 patients. Type 1 patients and based on all those patients type 2, they almost come into the table themselves because of their circumstances. So the focus is certainly, again on intensification or if we have patients that are naïve, are not controlled on the oral, I mean, that could be an initiation of therapy. So those are totally focused but it covers really the entire diabetes universe. And I would say as well as the physicians because we have phone calls everyday from physicians that are coming and saying, I have not being yet visited by a Sanofi whereby I had a patient coming, could you please let us know, or we basically then send on a Sanofi rep to inform the physician? So it’s way to make sure that they were expressing and the understanding of the product availability and how it works.
Jay Olson
Okay. Maybe just going on to reimbursement, can you talk about the -- I guess it’s called the Afrezza COACH program on the AFREZZA website where patients can enroll and they get, I guess their first co-pays covered and maybe some part of their subsequent co-pays? How is that going, how many patients are you getting signed up for this program and just any color you can provide on that?
Matt Pfeffer
Yeah. So just to clear, there is the COACH program, there is the co-pay program, there are discrete programs. The patient co-pay cards or the discount card has been in place since day one essentially and it allows the patient to go online and sign up for the card. They get their first month free and then they are assured even though by and large, AFREZZA is mostly in tier 3, not with every plan but for mostly these days. That that’s no penalty so the patient for that being the case so limit their copay to at least $30 which is not atypical for our Tier 2 product.
In addition, they’ve just recently started the AFREZZA Coach program, which is really a -- much like it sounds it’s in a patient assistance program, so it helps them understand how to use the product, how to get the most out of it, and to give them some nice little freebies to go with the - there is a carrying case and nice and things like that. But it’s really to make very well informed people available essentially 24/7 to the patients to help them to get the most out of the products and how to use and answer questions they might have and so forth.
They have done very successfully with their other products and we have a AFREZZA Coach program, I am not sure, excuse me, they have a Coach program for [indiscernible], I should call the AFREZZA Coach program, which -- and for their other products as well and they’ve had a lot of success with it. So I am really gratified they have now rolled it out. But it’s just been within last few weeks, that’s come online. So we’ve not seen any metrics for the coach program yet, but we have obviously higher hopes.
Jay Olson
I guess it was on their first quarter earnings call, there was talk about how the Tier 3 status did present an obstacle for certain patients and the prior auth. Can you talk about what steps are being taken to overcome the prior auth? And eventually, is there a chance that AFREZZA could move from Tier 3 to Tier 2 on some certain formularies? Can you walk us through that?
Hakan Edstrom
Yes. As I mentioned, look they call the [indiscernible] service is one of the activities that they put in place to help the physicians, the practice management, and even the sales reps in terms of coming over there and also provide the opportunity to get the paperwork filled out, because there are as many forms as there are different cannibalization structures for to get the prior authorization to minimize the burden for the physicians and the offices and eventually also for the patients, so the patient doesn’t have to go to the pharmacy get rejected and then have to go back to the physician and trying to work that out. And it’s been in place now for probably four, five weeks something like that.
So hopefully that’s starting to pay off in terms to facilitate. And eventually you should within six to nine months, the product is coming up for review by the insurance companies and at that time you get your carrying and by that time we certainly expect that the majority on prior authorizations will disappear in terms of requirements. Or if there is anything in place that maybe once a year or whatever that you have to reapply, but should not be then an obstacle to be put on the…
Matt Pfeffer
That’s an important distinction which occasionally is overlooked. I mean this prior authorization with Tier 3 is something that this become much, much more prevalent in recent months than it used to be and it’s certainly been and it delay for prescribing and we have experienced. But to a great extent that will naturally disappear as the insurance companies do their reviews which they as Hakan mentioned usually tends to be six to nine months out post launch and go on to put more permanent formulary placement and supposed to be in run through the prior authorization.
There is a huge difference between Tier 3 and Tier 3 to prior authorization from a patient and doctor standpoint. And it was mentioned I guess day or two ago by Sanofi, they have already had a fair amount of success getting out of the prior authorization requirements with some of the plans and industry Tier 3. So they went nicely, they have that we don’t is a big reimburse organization. We often talk to these people and negotiate formulary placement. So I think a lot of this is actually itself. In the interim, as Hakan mentioned they put in some mechanisms to ease the burden for the patient and doctor. So we hopefully start seeing the benefits of that in the coming weeks.
Jay Olson
Okay. At ADA, there was some discussion about the price of new novel insulin products and I think AFREZZA was mentioned in that discussion. Can you talk about what sort of discounting have you seen, has been more aggressive than you expected sort of just how that kind of wind up with your expectation?
Hakan Edstrom
Well, good news, if there isn’t really any discounting and so you complete that negotiation process. So it’s too early to really comment on that and it really depends on what their strategy is. If you want to end up in Tier 2, you have to discount much more heavily. If you can accept the Tier 3, then you may need little to no discounting, but that’s something that plays out in this six to nine months post launch period. So it’s really kind of early to comment for sure.
Jay Olson
Okay. Great. Looking ahead, can you talk about when we should expect to see new clinical studies for AFREZZA, pediatric study, the long-term safety study?
Hakan Edstrom
Yes, very short that actually during the third quarter I expect that we will start the dosing studies, the pediatric studies. Those protocols have now been agreed with FDA, so they are basically in the process of plants execution, the discussion that’s still ongoing with FDA and actually it’s a little bit later than planned but not because of us actually.
It’s the final protocol for the five-year safety study that we expect that probably will get underway hopefully by the fourth quarter, but those studies are well planned and some of them are underway in terms of execution as well.
Matt Pfeffer
Which is good because people asked about those, and I think the people, the ones most interested in our pediatric study and some of the dosing studies. The safety study is going to be a very long study so that it hasn’t started yet doesn’t really matter. It’s probably going to take seven, eight years easily to complete given it’s a five-year study within the sizeable in the client to enroll and to report as pretty lengthy.
And now once we get past these and the protocols are due with the FDA, Sanofi continue their attention to other things they talked about and they’ve not been very specific yet, but except with us about what their expectations are as label expansion and other studies that could help in the marketing of the product that better show the advantage has been the approval studies did.
Jay Olson
Okay. And then I guess when should we expect to see any studies for ex-U.S. approval and which market are you looking at next outside U.S. to launch AFREZZA?
Hakan Edstrom
Well, probably in most jurisdictions there is probably no need for additional trial, Japan maybe an exception where you have to do some additional clinical trials.
Jay Olson
And probably China.
Hakan Edstrom
And yes, probably, China, that’s great. Sanofi is currently in the process of looking at the different kind of parts of the world. I would say initially it will probably be driven by where is the regulatory process, say mostly inline, more aligned to the U.S. or maybe by the U.S. FDA approval is a significant kind of advance in terms of getting to the market in that. So that is scheduled to be discussed in these, Jay, actually committed with it within the next two meetings. So that’s being approach right now.
Jay Olson
Okay.
Hakan Edstrom
It’s very active way of discussion. People asked about Europe a lot. I mean, we did design our Phase 3 studies with European mind and based on discussions we have with them. So there is some hope that we could file there fairly quickly. That said, I mean, we asked them years ago about that and we all know things change in the regulatory agencies, so about to be approached and talk to. And I think there are these discussions like that going on to see what if anything might still be required to file in those kinds of jurisdictions.
And I think Sanofi is clearly interested in taking this to a lot of different places, but they want to have that cohesive worldwide strategy before they embark. And I think that’s what they are working on now and it should be presented to us this summer while agree on what it is. And then hopefully we can get more forthcoming with some certainty.
Jay Olson
Okay. Let’s move on to some financial questions. You’ve got $925 million in total milestones. You captured $175 million of funds, $50 million earlier this year. Can you give us some idea of sort of when you expect to achieve some of the additional milestones and maybe just some color on your confidence in capturing all of the total milestone in there in entirety?
Matt Pfeffer
That’s a trick one to answer. But it’s good you asked it. So the remaining milestones which totaled some $725 million of milestone are mostly sales-oriented. There are a few that are not. There is a $25 million milestone. It’s more kind of production seems oriented or development based milestones. There is a couple that are based on launching in foreign restrictions. The rest are sales based milestones. And it’s a constant struggle between companies to sign these agreements in the parent for the -- for the big pharma they sign them with, what they can disclose about that and at the end of the day, you typically find them more redacted, which is the case of that, which leaves us with a little ability to talk about them very specifically.
I will say that based on our own projections internally and the once we developed subsequently with Sanofi, we do expect to get all those milestones. The question is how rapidly, because they are based on the claims of those sales levels and clearly, we’re not projecting sales at this point.
So it makes it sort of circular and impossible to stay with exactly when they are going to be earned. But, yes, we didn’t sign an agreement that had milestones we think weren’t achievable. In fact, most of the things we talked about at the time were trying to emphasize that they start very soon and we believe they were all certainly achievable and that’s perhaps as much more I can say at this point.
Jay Olson
Okay. And then on the convertible debt that comes to in August, the $100 million, can you help us understand what options are on the table there and maybe give us some idea what your plans are for that?
Matt Pfeffer
Well, good news is we have a lot of options. Bad news is with the volatility and the stock and so far that we’ve experienced, currently it makes it harder to choose which one is the best one because it can change from day to day. And as we sit here at this moment and at least the last time I check the price and I did few months ago. I mean, they are in the money. They can just convert or we might want to and just conversationally, just to make them go away and have this not be an issue in people’s minds or we can extend them or stock them out.
There is just a whole host of the things that we can do. People talk about, worry about dilution and so forth. And I have a said couple of times publicly, one thing I can virtually guarantee we won’t do is the marketed secondary offering. That doesn’t mean there might not be some equity components somewhere down the road. It’s not going to be in a way that those shares would be readily made available to somebody who is a short of stock, just hypothetically.
I mean, a convert is still, is really just a matter of when it [Technical Difficulty], does it occur immediately or does it occur when they convert? I think the dilution from these instruments already have been factored in by everybody. So next time, we can do something without issuing more shares then we’d be issuing on to this instrument, I think we will be in good shape.
And I have almost daily talks with different organization and holders of the convert because they are very interested too. Most of the calls I get are from people looking because they like their paper and they want to keep it or some form of it. And so I’ve always said if we can find a way to do it that made sense for the company, we would probably extend it or roll out a bunch of the instrument. When we get closer, we will be able to see which makes more sense.
Question-and-Answer Session
Q - Jay Olson
Okay. We do have a few minutes left. At this point, I would like to check with the audience if there is any questions. Okay, we’ll keep going. Now you’ve taken a number of steps to reduce your cost structure, you mentioned on the earnings call that you closed your facility in New Jersey. Can you talk about how has your number of employees changed? You spend about $10 million on G&A in the first quarter, should we expect that to go down? And I know recognizing that this isn’t an opportunity to give guidance necessarily but just sort of how we should think about that going forward?
Matt Pfeffer
Yeah. We did say, it’s going down quite a bit. I mean, most of our spend is down by of a half from the prior year but it will continue to go down. The closure of the premise for its facility for example is something that we haven’t seen the benefit of it. I mean, that facility is now empty but we paid rent through May. So this month will be the first month to recognize that 50 something 1,000 a month savings.
In addition there were a lot of people there that are no longer with us. I mean, obviously some of the functions that were based there like clinical trials and regulatory so forth, we don’t need so meet people as we did because we’re not doing those kind of efforts any more. Those are now in Sanofi’s hand. Again as we allow those people, we’re able to find other uses for it or frankly some of them are in Sanofi now, which is a very good thing but some of them are gone.
So there were roughly 60 people in that facility. I think by the end of the month I could probably count the remainder but its still technically consider premise in place on one hand that will certainly result in some savings as well. And we have announced that our headquarters facility in California is now most of the MTD stage because so much of the operations have been streamlined and moved into the Danbury, Connecticut facility so that facility is not for sale.
We spend approximately a million or something a year just operating that facility, so that will be dramatic saving as probably million dollar just from that in addition to whatever we’ve been sales proceed. So there is a lot of things doing progress. It’s continually moving down, have to be pulled in so far but you should expect it to continue.
Jay Olson
Okay. Now in the first quarter you spend about $4 million on CapEx, should we expect that to come down over time? And is there any other color you can give us just in general on sort of cash run rate?
Matt Pfeffer
I give you firm maybe there, just kind of funny. There you should not expect that to be recurring. The most of that cost was associated with the final conclusion of the second two filling lines. So you’d probably remember went from one line to three since we tripling our capacity in that facility. I hope we’ll have to spend some more like that to again, increase our capacity but I wouldn’t expect that it will be this year or anytime real soon. It will all be body dependent and we want to be in a position to ramp up quickly if we need to.
Jay Olson
Okay. And just going back to the agreement with Sanofi briefly, another question that I know I get, you may have also received queries about is just in terms of if Sanofi did choose to opt out of the AFREZZA agreement? Can you describe for us what that would sort of look like in terms of their obligations or notification, any financial obligations, timing of how that would happen?
Hakan Edstrom
So, for all, I just look all the agreements just kind of complex, I don’t want to go into -- I’ll give you the broad brush. I mean, this document is the public document. So if anybody wants to go into details they can find it. And obviously, we have no reason to think that and we have a lot of reasons to think the opposite, but Sanofi is very devoted to this product and has a firm commitment.
If they decided they wanted to discontinue, their first opportunity wouldn’t be until the beginning of next year and at which point they have to be trigger a notice period. So there is no -- somebody misinterpreted something and posted something about their -- they could potentially turn it as quickly as next month, that’s completely untrue.
The first opportunity to give us notice of their intend to discontinue be next year or sometime and then there is three, six months be what it is or the reason for the termination and then there is some potential continuing obligations relating to trials and so forth after that.
Jay Olson
Okay. And then just looking beyond AFREZZA at the Technosphere platform, you’ve spoken about opportunities potentially in supported care of cancer, talking about pain, respiratory disease? When should we expect to see any potential catalyst milestone with regard to new applications on the Technosphere platform?
Hakan Edstrom
Well, we took actually a decision together with the Board yes, recently. So the first project is now underway and we’re getting the API and actually this week we are beginning the discussion internal, how to deal this discussion in regards to adopting one other projects. And we also have a couple of discussions going on with the external potential partners at the point in time.
However, I would say that our assumption is that we will take these two say, proof-of-concept in regards to that that we have differentiate the product. And at that time, at least for the first couple of projects we would look at partnering opportunities that’s what we would kind of seek our partners.
I would say that its probably say, 18 to 24-month period in terms of bringing this still validation through development into proof-of-concept before you would see us necessarily go out and sign specific deals unless we stumble upon something kind of.
In the meantime, because our idea is to have, I will say, the portfolio of four to six projects that we will be pursuing during this time and over the next say, six to nine months, hopefully we will get that.
And from there we will under pursue because we have about 35 people that’s devoted to this one. So we do have the experience. We do have the resources. We just need to make some market decisions in terms of which one they are of this products we are pursuing that can provide the financial incentives to us and the partner and the market opportunity.
Jay Olson
Okay. Very good. With that we’re out of time. So wrap things up. I want to thank you again for joining us here today. Appreciate it.
Hakan Edstrom
Thank you.
Matt Pfeffer
Thank you.
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DEFINITION of 'Short Sell Against the Box'
The act of short selling securities that you already own.
This results in a neutral position where your gains in a stock are equal to the losses.
For example, if you own 100 shares of MNKD and you tell your broker to sell short 100 shares of MNKD,
you have shorted against the box.
PS: Could AL MANN be doing this ?
Does this have to be reported to the SEC ?
MNKD SI
Post # of 12065
12 months of Short history on MannKind. From 69 Million to 131 Million shares. Where do we go from here?
http://www.nasdaq.com/symbol/mnkd/short-interest
*** Failure Swings
Wilder also considered failure swings as strong indications of an impending reversal.
Failure swings are independent of price action. In other words, failure swings focus solely on RSI for signals and ignore the concept of divergences
***A bearish failure swing forms when RSI moves above 70, pulls back, bounces, fails to exceed 70 and then breaks its prior low.
It is basically a move to overbought levels and then a lower high below overbought levels.
Chart 8 shows Texas Instruments (TXN) with a bearish failure swing in May-June 2008.
SEE CHART SCHOOL
http://stockcharts.com/school/doku.php?st=rsi&id=chart_school:technical_indicators:relative_strength_index_rsi
Equity Coverage placed under Extended Review
We are placing the following equity securities under extended review due to
reallocation of resources. Investors should no longer rely upon our previously
published reports, recommendations, price objectives or estimates.
Table 1: Equity Coverage placed under Extended Review
Company name BofAML Ticker
ALKS Alkermes plc
ARNA Arena Pharma
ESPR Esperion
KPTI Karyopharm
MGNX MacroGenics
MNKD MannKind Corporation
MEIP MEI Pharma
NKTR Nektar
OREX Orexigen
PRTA Prothena
SRPT Sarepta
SGEN Seattle Genetics
MDCO The Medicines Co.
VVUS Vivus, Inc.
Source: BofA Merrill Lynch Global Research
MNKD SI
5/15/2015: 112,949,758
4/30/2015: 100,934,186
4/15/2015: 96,880,182
3/31/2015: 95,717,587
3/13/2015: 90,882,779
2/27/2015: 90,734,471
2/13/2015: 86,114,829
1/30/2015: 80,678,801
1/15/2015: 76,855,662
MNKD
spirometer issue resolved $500 to $600 as stated today in Sanofi Afrezza session
Seems we have now resolved the Spirometer issue. Sanofi indicated today at a packed session this morning that a doctor can buy a model for $500 to $600 .
Will new RX'S now surge ?
This could be some thing big.
.....................................
Mannkind & Torrey Pine Joint U.S. Patent - Treating Pain
United States Patent Application 20150150980
Leone-Bay; Andrea June 4, 2015
.................................................
Applicant: MannKind Corporation & Torrey Pines Institute for Molecular Studies
METHODS AND COMPOSITIONS FOR TREATING PAIN
Abstract
Methods and compositions for treating pain are disclosed. The compositions are based on dry powders comprising microparticles of diketopiperazines and an analgesic active agent. The analgesic in the compositions comprises one or more peptide analgesics or derivatives thereof, which are administered to a subject using a pulmonary inhalation drug delivery system comprising a dry powder inhaler and the analgesic composition. The present compositions produce fewer side effects associated with current opioid therapy.
CONCLUSION
XBI is a better etf than IBB
why ?
Because each stock is a lower percentage of the total.
GILEAD AND REGENERON LEAD BIG BIOTECHS... Chart 5 shows the Biotech iShares (IBB) with a similar chart pattern. In contrast to XBI, this ETF is weighted towards market cap. Notice that the top ten stocks account for over 50% of the ETF and the top five account for 38%. Chartists interested in this ETF should also analyze the charts for GILD, AMGN, BIIB, CELG and REGN, which is basically the who's who of biotech. Also note that biotechs account for around 8% of QQQ.
...........................................
...............................................................
Chart 6 shows CandleGlance charts for the top six holdings in IBB. These are just quick and dirty chart assessments, which are sometimes the best because too much thinking can be dangerous. GILD, RGEN and MYL are the clear leaders because they are trending higher and their 20-day SMAs (blue) are above their 50-day SMAs (red). GILD broke out with a surge above its December-January highs. REGN Broke out in March, pulled back and then broke out again in May. MYL surged in March and April, and then consolidated with a pullback in May.
On the weak side, the 20-day SMAs for AMGN, BIIB and CELG are below their 50-day SMAs. AMGN is testing support at 155, a break of which would be bearish. BIIB bounced in May, but is hitting resistance in the low 400s and a breakout here is needed to reverse the slide. CELG has been trending lower since mid March and resistance is set around 120. Breakouts in these three would help the biotech ETFs.
BIOTECHS LEAD HEALTHCARE ... Chart 4 shows the Biotech SPDR (XBI) hitting a new closing high last week. With this new closing high, I extended the Raff Regression Channel from the prior closing high (mid April) to Friday's closing high. Key support does not change and remains in the 200-210 area. The lower line of the Raff Regression Channel and March-April lows mark support here.
.................................................................
The March-April decline looks like a big falling flag or channel, which is typical for a correction within a bigger uptrend. The breakout and new high signal an end to the correction and a continuation of the uptrend. Before getting too bullish, note that trading has been choppy the last three months and the ETF is up around 15% from its late April low, which makes it short-term overbought. XBI is a very broad-based ETF with 97 stocks. GEVA weighs the most at 2.02% and OTIC weighs the least at .62%.
FROM BOA :Analyst Note
We are lowering our fair value estimate for MannKind to
$3.70 per share from $6.50 and maintaining our no-moat
rating as the early trends from Afrezza's recent launch in
the United States are disappointing. We are therefore
slowing the sales ramp and peak sales of the drug to $1.6
billion from $2 billion in our model. It is still early days,
and MannKind's partner, Sanofi, is leading the launch;
with its extensive experience and commercial
infrastructure in the diabetes market, we think the inhaled
insulin drug has a reasonable chance of being successful.
Nevertheless, given that MannKind's future relies entirely
on Afrezza's success and its cash balance is dwindling,
we view the shares as having a very high uncertainty rating
and as fully valued at current prices.
MNKD:FROM BOA :The company finished Q1 quarter with a cash balance of
$121 million, which was replenished by the $50.0 million
milestone payment from Sanofi for the Afrezza deal;
however, given its current burn rate and debt, MannKind
will probably have to raise additional capital in the coming
quarters unless Afrezza trends improve significantly in the
near term.
MNKD FROM BOA
Bulls Say
OAfrezza has demonstrated a much more
favorable side-effect profile compared with
injectable rapid-acting insulin therapy. Long-term
safety data also indicate that the product does not
cause a decrease in lung function.
OMannKind plans to price Afrezza at parity with
insulin analogs and has developed its device to fit
comfortably in the palm, which should remedy the
reimbursement and design issues encountered by
Exubera.
OMannKind has signed an Afrezza commercialization
deal with Sanofi, an ideal partner with extensive
experience and commercial infrastructure in the
diabetes market.
Bears Say
ODespite Afrezza's approval and partnership
with Sanofi, the product could flop on the market.
Exubera was removed from the market after it was
deemed a commercial failure thanks to its hefty
price tag and bulky design.
OBeyond Afrezza, MannKind has only a few
early-stage products in its pipeline, making the
company's future almost entirely dependent on
Afrezza.
OSafety concerns linking Exubera use to lung
cancer in former smokers prompted diabetes
experts such as Novo Nordisk and Eli Lilly to
discontinue their inhaled insulin products.
Is MannKind a Buy?
By Brian Feroldi | More Articles
May 29, 2015 | Comments (5)
Over the past few weeks I've been doing a deep-dive series exploring the history and future prospects of MannKind Corp. (NASDAQ: MNKD ) . Now that we know the company far better, it's time to ask the ultimate question: Is MannKind a buy?
Ever since it went public in 2004, the stock has had both bulls and bears proclaiming the merits and shortfalls of the company. Thus far, the bears have been correct about the direction of the stock, as the company has shed more than 60% of its value over the past decade, while the S&P 500 has almost doubled.
Ouch.
The opportunity in front of the company, however, remains enormous, as the Centers for Diseases Control and Prevention estimates that 29.1 million Americans suffer from diabetes, with that number reaching as high as 387 million worldwide. That number is predicted to grow rapidly, with an estimated 592 million patients expected to be diagnosed worldwide by 2035.
In pursuit of that massive opportunity, MannKind developed its first and only drug, Afrezza, an inhaled insulin that's designed to treat both type 1 and type 2 diabetes. MannKind, along with marketing partner Sanofi (NYSE: SNY ) , officially launched the drug for sale this past February.
Afrezza has several advantages over traditional insulin injections. Afrezza is inhaled and absorbed in the lungs, which both eliminates the need for meal time injections and allows the insulin to reach peak effectiveness faster than other insulins currently on the market. This faster action can help patients better control their blood sugar levels before and after a meal, which could make the drug very appealing to patients who currently take multiple injections ever day.
Still, huge questions remain unanswered about the drug's market potential. Will Sanofi be able to convince patients and providers that Afrezza is safe and easy to use? Will MannKind be able to hit all the milestones needed to receive the additional $775 million in payments from Sanofi? Will Afrezza wind up in the dustbin like Pfizer's earlier inhaled insulin Exubera? How will big pharma fight back against Afrezza?
We got a small glimpse of early Afrezza sales results when MannKind reported first-quarter earnings, and Wall Street didn't like the news. The company mentioned that early adoption was modest, largely due to required lung function testing prior to patients starting treatment. Management is working to overcome these obstacles, but this uncertainty has punished MannKind's stock over the past three months, as the share price fallen nearly 25% since Afrezza was launched in February.
MNKD Chart
Does the drop present a buying opportunity?
MannKind's stock is very high risk, as its near-term future is tied directly to the sales of only one very new drug. Yes, MannKind's Technosphere technology could one day find its way into many applications beyond diabetes, but those opportunities remain untapped, and the company has yet to officially announce any new partnerships.
For now, I'm personally going to stay away from MannKind's stock, as there's just too much risk at play here. Before I'd consider investing, I would want to see proof that Afrezza sales are growing rapidly, that the issues causing the delay in sales are dealt with, and that MannKind recieves one or two more royalty payments.
If those things happen, it's likely the share price will be many multiples higher than where it is now. I'm OK with that, as even if the company doubled its share price from here, the market cap would still be valued around $4 billion or so. If Afrezza really is the wonder drug we hope it will be, and the Technosphere technology platform ends up with other announced applications, there would still be plenty of upside left. But until that happens, I'm happy to sit on the sidelines and watch the story unfold.
JLS Saturday, 05/30/15 12:05:28 PM
Re: Actually it was a 4-day week.
First ...
The usage data just reported was for the period ending on Friday, May 22. Memorial day was on the following Monday, May 25. So the week being reported was a standard 5-day work week.
Second ...
People having Diabetes really do need their medicine. They are not going to wait till the last minute and run out of their medication then all of a sudden discover that their favorite pharmacy is closed because of a holiday. Furthermore, I went shopping on the Monday of Memorial day, and two of the stores I went to had pharmacies and their prescription windows were open. They are also open on Saturdays, and maybe a few hours on Sundays.
Third ...
None of these statistics mean anything (except for one statistic). The Afrezza numbers being reported are so small such that it is much too early to make any conclusions regarding rates of adoption of Afrezza, except for one conclusion.
What is that one conclusion? On the scale of people having diabetes in the USA, the number of Afrezza users could just as well be 0. It really doesn't matter if there were 58 refills during the last week reported or 100 refills during that week. As of 2012: "29.1 million Americans, or 9.3% of the population, had diabetes." What does 58 really mean when compared to 29,100,000?
VERY GOOD URL BELOW
http://www.diabetes.org/diabetes-basics/statistics/
FROM WYCKOFF POINT OF VIEW
Started Wall Street career in 1888
I propose that when the short interest trend turns down,
it will signal that the smart money has finished accumulation
and is ready to bring MNKD's price down
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