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Post by matt on Jun 14, 2016 16:38:23 GMT -5
It kinda of suggests desperation in filling the remaining slots, which btw, I thought was already a done deal. Oh well. Publicis is not a career for most of their sales people, often they are experienced pharma or med device people who have been victims of downsizing. If a contract rep get an offer of full-time employment with another company, they would be idiots not to accept it because it probably has a substantially higher salary, better benefits, and more job security.
It is not a reflection on Mannkind if Publicis can't fill 100% of their openings. Besides, you don't know who else is staffing up in those four markets and for what type of product; it may not even be a pharma or med device company hiring the good prospects. Most pharmas would hire where they could and relocate the new employees, but that rarely happens in contract sales due to the cost and lack of employee loyalty.
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Post by matt on Jun 13, 2016 12:35:50 GMT -5
I don't know if that insulin will ever be used in the United States. But they should use it to enter other countries. What you are suggesting is illegal. Either the insulin is good drug, in which case there is no reason it can't be sold in the US, or it is expired product in which case it cannot be exported. FDA applies the same quality regulations to domestic and exported drugs.
What many people don't realize is that active pharmaceutical ingredients don't permanently expire the way a manufactured product does. While raw material has a presumed life based on its stability testing, many times that testing is limited to three years. After sitting on the shelf for three years, a sample can be retested and if it passes the lot is reclassified to unexpired. This can happen multiple times and some molecules essentially never degrade. All that FDA cares about is that the medicine as released to the public will be safe and effective, and not how long the API has been sitting in inventory.
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Post by matt on Jun 10, 2016 14:46:27 GMT -5
This was a better short a year ago when the price was still above $6. While there is theoretically money to be made all the way to zero, the lower the price the higher the risk that the stock will pop unexpectedly and cause some pain. That was less of a risk at $6 and poorly performing script numbers than it is now at $1 and a new marketing plan.
The biotech world always has high PPS targets that are overpriced relative to fundamental value. No use chasing the last few pennies in $1 stocks when there are easier pickings elsewhere for those that like to trade the short thesis. It may not be MNKD so much as MNKD in comparison to other opportunities.
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Post by matt on Jun 10, 2016 9:52:09 GMT -5
Sounds like an assisted short covering....lol Which is a win win for shorts. Almost makes me wonder if that is why that language about the trust dumping was in the 10-q It could be a short covering a position, but somebody shorting MNKD in a big way would know where to go to buy up shares on the cheap; no need to advertise it. I think the reason the language was in the 10-Q is because it was a material fact and the officers felt it had to be disclosed once they knew it (which I agree with). Given the number of shareholders kept in a constant state of darkness by non-communicative management teams, on balance this is a better way to dealt with the markets. MNKD may win or lose, but at least management is playing the game honestly. |
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Post by matt on Jun 8, 2016 14:33:25 GMT -5
Somebody dumped or bought 1,000,000 share at 14:00:27 today Very strange that 1,000,000 shares doesn't move the price at all. I'm not sure how accurate yahoo is, but it shows a large green candle which would be an order to purchase, right? If so, there must be a LOT of shares for sale at $1.02 to keep the price from going up. My guess is some short covered 1,000,000 shares and mann's trust is selling and is able to single handedly keep the price down while they sell (not that they want to, but they have nearly 1 or 200,000,000 shares to sell)... thankfully they decided to sell over $1 I guess. if true, what a perfect situation the shorts have to cover. The light at the end of the tunnel for me is that once they cover or Mann trust stops selling, it seems very realistic for the price to increase. I'd imagine shorts would soon after turn long. If the shares are from the trust, this would not be unusual. Many times when a major holder wants to move significant blocks without crushing the price, they use a friendly brokerage firm to find a block buyer and the deal is negotiated off the market. When the shares trade hands, the broker has to report the executed trade to update the tape but since there was no 1 million share transaction hitting the bid there was no opportunity for the HF trader to try and jump in front. When you see a big volume trade with no price movement it is almost always an off-exchange deal that has already happened. |
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Post by matt on Jun 6, 2016 15:21:03 GMT -5
Not to put words in anyone's mouth, but capnbob appears to be using a definition that describes "Onset of Action" as the of time it takes from when the insulin is administered to when it enters the bloodstream...similar to the definition used within the Humalog website.
However, for the sake of discussion, that is not the definition defined by the authors. Regarding the abstracts under discussion, the authors published a specific definition of the term "onset of action" that is used in the study and presented in the abstract/publication.
Therefore, if you, capnbob , or anybody else wishes to unilaterally alter the authors' definition of "Onset of Action" to your own definition, you can basically say anything you want and it's supported by your specific definition(s).
Unfortunately (or fortunately, depending how you look at it) you are no longer validly arguing the merits of the authors' presentations.
Fair point, there are a lot of terms thrown around that would be more helpful if they were more precisely defined and used in a consistent way. The other point with regard to posters is that these are not super rigorous scientific studies meant to reach a supportable conclusion; they are often small studies taking a quick look at something of interest. The abstract comparing Lispro to Afrezza was done on just 30 subjects and, statistically speaking, it is hard to support any particular conclusion over another with a high degree of confidence such as what would be required to get a label. For that you need several hundred subjects stratified for age, sex, and ethnicity, and that is especially necessary in a statistically noisy diabetic population with so many comorbid conditions.
Most of all, realize that these are poster sessions and not plenary sessions or therapeutic tracks with Powerpoint presentations. Those researchers who are interested after skimming the abstract will note the number, will seek out the poster, and can grab a copy of the write-up for later consideration. Posters are meant to further research by sharing how others have designed experiments, and provide the opportunity to meet other researchers with similar interests. The posters are not seen at all by the vast majority of attendees who are too brain dead after sitting through six hours of meetings in dark rooms, sitting on bad chairs, trying to absorb an endless stream of Powerpoint slides. Those who try rapidly succumb to eyeball overload and complaining feet (for some reason poster sessions are always held on concrete floors). |
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Post by matt on Jun 4, 2016 14:24:19 GMT -5
It is also I believe possible to obtain approval from the MHRA, the uk Medicines and Healthcare Products Regulatory Agency, if what is wanted is only approval for the UK. That is an alternative to the EMA but is of course only UK wide. However once authorised in the UK there is a 90 day (excluding time answering questions) process to get mutual recognition of a drug in the rest of the EU based on mutual recognition of the UK approval. See www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk#MRPYou are correct that there is still a country by country licensing procedure available, but it is very rarely used these days. While, in principle, every other EU country is supposed to review and rubber stamp an approved dossier from the originating country, it is significantly more cumbersome and expensive than the centralized approval process which is why it isn't used any more.
On your other point, regarding physician working for both the NHS and taking private patients, that is the way it is in most EU countries. The private patients make up 10-20% of the patients seen, but can represent 80-90% of the physician's revenue (especially in places like Spain). Focused marketing on private hospitals is the way to go to launch anything that is novel, more expensive, and needs some serious sales attention since the national insurers aren't likely to cover a new and more expensive treatment in most of the countries (there will be exceptions).
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Post by matt on Jun 2, 2016 14:21:58 GMT -5
At the risk of sounding cynical, remember that 2008 was an election year and Wisconsin was in play as a potential swing state (Harley-Davidson is headquartered in Milwaukee) and a lot of jobs were on the line. Maybe Mannkind needs to relocate its operations to a battleground state with lots of electoral votes!
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Post by matt on May 30, 2016 8:15:42 GMT -5
Tradeshows are country AG fairs. Tradeshows are, sure. But is the ADA conference a tradeshow or is it a serious scientific meeting? I've never been to the ADA conference, but the web site suggests it is the latter (a scientific meeting): www.afassanoco.com/ada/I've been to many scientific conferences in my day, and never seen the sort of gimmicks some have suggested. (IOTW, exhibitors at a scientific meeting behave differently than exhibitors at a tradeshow or county fair.) Big meetings like the ADA are mostly serious science, partly trade show, with a dash of street theater thrown in. The plenary session and scheduled presentations are all serious science as you would expect, as are the poster sessions. These are all vetted by the conference organizers and it is very bad for your karma as a scientist to cheapen the event. There can also be PAID presentations which take place before or after the main conference (i.e. 6:30-8:00 in the morning or early evening). These are quasi-promotional scientific lectures sponsored by pharma companies and, depending on the meeting, can be seriously informative or so full of fluff that you regret waking up that early.
The exhibition floor is pure capitalism at its finest. Companies rent booths to display their products and services, and nobody expects this to be objective science. It is where convention delegates can collect a lot of freebie promotional items and brochures that they will probably never read later. Mostly it is a good chance for smaller organizations to get their name out there. Part of the game is to get attention on YOUR booth, which requires a bit of showmanship if you do not have the dollars for a huge space guaranteed to attract attention, hence the need for a bit of street theater.
The most effective street theater I can recall was from an International AIDS conference I attended in the late 1990's where Durex had a booth with free condoms and a display where they would blow up a condom with an air compressor until it burst with a big boom. People stopped and watched multiple times (condoms can hold a very impressive amount of air before bursting). It was a good display because it was relevant to their product and got them lots of foot traffic; I think that was fair game given the conference. Depending on patient activism, some meetings can be part science and part political events; the international AIDS conferences were always something of a circus (think San Francisco gay pride parade meets the Nobel presentation awards) but way more fun that the other medical meetings I have attended.
I agree that for the ADA meeting a "live demonstration" would probably not be appropriate. Most attendees already discount the truth of anything shown in the commercial exhibition hall and I don't think that demonstration would be enough to stop traffic.
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Post by matt on May 28, 2016 10:26:52 GMT -5
A lot depends on what you mean by "deal". The only thing you can do quickly in the pharmaceutical world is to fail. It takes two to tango and just because MNKD is eager for a deal to prop up the optics of Afrezza until they can get real progress on the business side does not mean the counterparty has the same sense of urgency. If the counterparty smells desperation they can, will, and should take advantage of that.
Everyone seems focused on foreign deals, something I have a lot of experience with (and the 3 million frequent flyer miles to prove it, I managed four businesses worldwide, except the US, with sales in over 120 countries). High value deals with up-front cash come from pharma companies eager to corner a global market, which is why Sanofi paid $150 million plus promised more if Afrezza had taken off. That is the world of big pharma; global deals which have nearly always included the US since the early 1990's. Those that do not do global deals are typically smaller family owned or regional players that behave more like pure distributors than real pharma companies because they sell mainly generics and off-patent drugs. For comparison, I would urge you to take a look at the financial returns of the big distributors (Cardinal Health, McKesson, Amerisource Bergen) who all operate on very thin profit margins, averaging about 1% of sales. Distributors are rarely hungry enough for a new product that they pay anything for the privilege of selling it because the margins simply are not there, while in pharma there are fat profits to be had. It will be exceedingly difficult to find true pharma companies willing to take on Afrezza without the US market included in the deal. It will be possible to find small local pharma companies, but they will not have the deep pockets needed to solve MNKD's financial problems.
As agedhippie noted, EU is a two step process with the EMA being the first barrier requiring a minimum of nine months to get approval (assuming everything is perfect), followed by national coverage decisions. There are 29 countries coverage by EMA approvals and there are 29 different sets of rules for national coverage decisions. It is an extremely time consuming process which sucks a lot of management energy. When I was a road warrior I was in my mid-30's to mid-40's and at times it damn near killed me because I started a 6:30AM working with the Middle East, Africa, and Europe, moved on to the UK around lunch, got a short breather in the early afternoon, started again with Australia / New Zealand late in the day, and worked Japan and the rest of Asia from home in the evening. It was a grind and I had one of the industry's best international business groups supporting me (legal, logistics, finance, regulatory, manufacturing). MNKD doesn't have that kind of infrastructure and cannot be successful at managing many small international deals without it.
Like it or not, MNKD will live or die based on what they can do in the US and anything else is a distraction at this point. Matt needs to be laser focused on US sales and shareholders should encourage the entire organization to focus their efforts on increasing US prescription numbers. If that happens, the company can look at foreign expansion in a year or two; the diabetics aren't going anywhere. Bad deals can be closed quickly, good deals can be had only with time.
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Post by matt on May 27, 2016 9:56:50 GMT -5
All drug regulators require extensive testing on molecular stability under a range of conditions (light, temperature, humidity, etc.) and times (3 mo, 6 mo, 1 yr, 2 yrs, 3 yrs are typical). Those test results make their way into the label copy and expiration dating. I suspect that if all MNKD could prove was two months stability, FDA would have required two month expiration dating which would be a nightmare for the distribution channel to manage. Most drugs can withstand considerably more abuse than implied on the label and expiration dating, but you never know what the real limits are unless you are the person doing the testing.
The FDA defines "room temperature" to be 20-25 degrees Celsius (about 68-77F) with brief excursions within a range of 15-30C (59-86F) and very brief exposure to 40C(104F). "Refrigerated" means 2-8C (36-46F). Most long-term stability testing for room temperature profiling is done at 25C +/- 2C and 60% humidity so I suspect Afrezza had stability issues under those conditions. It may be that the drug can handle that temperature but the powder formulation cannot withstand the humidity; refrigeration removes humidity so that may be the reason for specifying storage in the refrigerator after 10 days.
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Post by matt on May 26, 2016 11:32:32 GMT -5
I think the key here is to realize that the types of people you see in a typical Rodman & Renshaw deal are not what you would consider true investors. They do zero due diligence because they don't really care if MNKD is going to trade up, down, or sideways because they will be cash neutral within a day or two with essentially no risk. This week it could be a biotech opportunity, next week an energy deal, and the week after a semiconductor company. The investors simply don't care at all about the company; it is all about the chance to make a few percent on the discount and/or on the warrants.
Making small returns might not sound exciting, but if you could make a guaranteed 2% in exchange for tying up your money for a week, what does that get you on an annualized basis? Once somebody is known as a reliable "go to" investor on this type of deal, Rodman and the other banks that play in this space will call again and again. There may not be a placement every week, but over the course of a year a reliable investor might get a piece of 20-25 deals. Those little 2% profit bites add up to a nice income.
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Post by matt on May 25, 2016 15:32:17 GMT -5
There's nothing there that says they "plan" on selling. All it says is that they "may." Depending on circumstances I leave open the possibility that I also "may" sell, but the chances of my doing that anytime soon are highly unlikely. Trustees have a fiduciary obligation to act in the best interests of the beneficiaries of the trust. It doesn't matter what is best for Mannkind or what Al personally would have done or what Al's wishes would have been; all that matters is the language that made it into the trust indenture. Sometimes the drafting lawyer manages to accurately convey the grantor's wishes precisely and sometimes not, but it is difficult to get such things changed after death of the grantor.
A cardinal rule of trust law is that trustee must act with "prudence" and allocating an excessively large portion of the corpus of a trust to a single security is normally considered imprudent unless the grantor specifically provided otherwise. The trustees are usually lawyers and financial professionals that work for specialty divisions of banks or trust companies, and they take their responsibilities very seriously since they and their institutions can be sued for breaches of their fiduciary obligations by the beneficiaries if the value of the trust is diminished because the trustees failed to diversify the portfolio.
We can't know what is going to happen because we don't know what the grantor (Al) put in the trust documents, and because there are various trusts there may be different language in different grants. However, if the main contributions to the trusts were made with stock in entities that Al founded it would not be surprising to see a little portfolio realignment going forward. Time will tell.
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Post by matt on May 25, 2016 12:15:25 GMT -5
If I'm reading this study correctly, it allows a company to run a simulated trial. Very cool. This simulation can show you where you have gaps or problems with the trial protocol. Then you tweek the protocol parameters and run the simulation again. Once you feel that the protocol is good, you use real people. I've never heard of this. Wow. This takes the use of algorithms to the next level. Yes, you are reading that correctly. Experiments used to be done in vitro (test tubes) or in vivo (living animals or humans) but since about the 1990's the term in silico (in silicon) has been adopted for computer simulations. Simulations will never replace in vivo testing, but as simulation techniques improve they can be used to avoid conducting studies that are doomed to failure before they even start. That saves a lot of time and money (and the rats appreciate it too). |
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Post by matt on May 24, 2016 6:47:21 GMT -5
Clinical commissioning groups (CCG) are groups of general practitioners that decide on which products and services are provided to their patients. They operate similar to NICE, except that NICE deals with extremely high priced drugs (mostly cancer and rare disease treatments). CCGs are more like insurance company panels that decide on whether Afrezza is on or off the formulary, except in the UK if you are not on the formulary then you are totally off. Since NHS is the single payor for most of the patients in the UK it pretty much comes down to having NHS coverage or going 100% self-pay.
Note that this is separate from the European Medicines Agency which, like the FDA, has to approve the drug in order for it to be sold legally. Obviously you need both the license to sell and a willing payor to have a business.
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