|
Post by stevil on Apr 7, 2016 15:46:33 GMT -5
First Post, Shareholder, Voyeur of this board and others. Just wanted to share a recent experience. Had my yearly blood work done end of March. Call back from PCP's office (Nurse) message: You have high blood sugar and now are considered Diabetic. Reviewed my blood test results on their "My Chart" online Medical Management Program. Results: Non Fasting Blood Sugar 399. Called back for fasting BS or HbA1c and number was 11.9 Met with my Cleveland Clinic PCP who resides in a large Cleveland Clinic off campus facility in a very large Cleveland suburb. Was given the required speech of what Diabetes is all about and what I need to do. Meeting with Dietician, scheduled for new blood work first of June and placed on 2000 mg of Metformin. Asked my Doctor if he had heard of the new inhaled insulin "Afrezza" he said NO and asked who makes it.... Seeing my appointment was within the time frame of Sanofi handing Afrezza back to MNKD - it was no time to share that information. I just told him there was a new FDA treatment on the market that was inhaled. Fell on DEAF ears. He went on to say that Pfizer had an inhaled insulin that was a big flop and was not an improvement over current insulin therapies. Hence, 2000 mg. of Metformin 1x per day for a grand total with my insurance of $10.00 for 90 Days. Can not be far from the commode room and CAN afford Afrezza. Sucks. (Female- 57yrs. 165lbs. 5'4") Don't give up! I'm sure you'll get a script for Afrezza if you ask for it and your body will be the proof your doc needs! Best of luck to you on your new journey! Hopefully you get back to the point where you don't need insulin.
|
|
|
Post by stevil on Apr 7, 2016 15:41:42 GMT -5
here's the first post of this thread. I don't think I'm kicking anyone who's down. If I am, I sincerely apologize. That is not my intent in the slightest.
[Bankruptcy is] Laughable. The gap necessary to fund us for another year or two is doable in my opinion. If we are so starved for cash he deal with RLS could have been front loaded with immediate cash up front, no? Perhaps leaving more on the table long term. Furthermore. A secondary would aid us. Short stock gets beaten down, long term runway geta extended a year or so. I am very happy with my MNKD investment. Down. But no way in hell I sell. No much freakin potential in this baby.
God speed to Afrezza. And may Sanofi continue to lose market share to other insulins. Eventually being bought out by MNKD. Just kidding. Who wants to buy garbage. Haha.
|
|
|
Post by stevil on Apr 7, 2016 15:32:56 GMT -5
makes sense, thanks!
|
|
|
Post by stevil on Apr 7, 2016 15:18:45 GMT -5
welcome back patryn!
|
|
|
Post by stevil on Apr 7, 2016 15:13:30 GMT -5
... I'm unsure if the patent protects from R&D or just sales, but I'm wondering if a generic manufacturer wanted to, if they could start immediately on cracking the code so to speak so that once the expiration is up, they could immediately sell the drug. It would kind of seem likely to me that this is allowed since generic drugs hit the market as soon as the patents expire for nearly every drug I'm aware of. Making pills out of stable compounds is relatively easy. Stabilizing (insulin human) monomers in a usable form is not so easy. It's obviously going to take MNKD a while to develop the market. MNKD hoped that Pfizer would have done so with Exubera, but they gave up. Now, MNKD has to develop the market and protocols. Until MNKD is clearly on track to make Afrezza a blockbuster, I don't think any other BP's are going down the rabbit hole to copy inhaled insulin. I seriously doubt a generic manufacturer would attempt such a feat. Even the Chinese probably know better. GSK is looking at other dry powders since they seem to realize that stabilizing hormones could be profitable. Most will probably only awaken from their BP slumber after Afrezza drinks their milkshake. This is the way of the world. Few ever see the next big thing coming until it came and went. Do you know how Martin Shkreli's business model worked for buying a generic and raising the price? It takes time to ramp up even when everyone knows how to make it. You can thank the FDA for that. I see your point about starting development now to figure out how to stabilize monomeric insulin. However, we've given people an incredible head start. They know the molecule that can do it (FDKP). Now they just have to figure out how... it now becomes a physics experiment, and there are a ton of brilliant minds out there. I agree with you that Afrezza would have to make it big for a generic copy cat to get made. I thought I'd stated that point in my post but maybe not... The good thing about our portfolio is that it SHOULD only take one drug making it big to pave the way for the others. Hopefully once people get used to inhaling medicine and realize the benefits of it, it'll make adoption of the other meds that much easier. But yes, hopefully Afrezza either makes ridiculous amounts of money, and very quickly before the patent runs out... like several billions of dollars, or only makes enough to not even be worth it to a generic manufacturer to figure it out so we can be the only company that sells inhaled insulin for decades... Although I think stem cells will be curing diseased pancreases before too long.
|
|
|
Post by stevil on Apr 7, 2016 15:06:26 GMT -5
Reply: The conspiracy to get rid of Afrezza showed it's self when it was priced three times higher than the latest and greatest subq fast acting. No insurance coverage. With single payor coverage $500 dollars a month or more, it is difficult for many. Then the physicians. repeating myself, "I have never seen physicians stiffen up like that." Sweedee proved that when push comes to shove, you can get it... then the cost,,,
I do not believe the physician is all knowing. I do believe you know physiology forwards and back wards. Acute so different than chronic. Best of luck to you Stevil, you get to evaluate the mechanism of action. (for the rest of your life) May you choose the correct one. Peppy, I'm not your enemy! Thank you for your kind response. I hope mine are just as sweet. I know my tone isn't always the best in my writing, so I apologize ahead of time for that. I try my best to not be offensive, but I'm far from a politician. I don't know how to make my words palatable to my listeners. I just say whatever is on my mind without thinking about how they're received and sometimes it leaves them open to interpretations I'm not intending. Anyway, I don't think the outrageous pricing was intended to sandbag Afrezza. I think it's clear that SNY had an idea of what they wanted for Afrezza and they wanted it to be about what they'd get from each Apidra script. Might have been bad business sense, but I don't think it was malicious. No insurance coverage has more to do with the insurance companies not wanting to pay what SNY wanted for it. Again, more to do with the juice not being worth the squeeze to SNY. They probably figured they could create a more profitable drug with all the money they'd eventually invest in Afrezza. That's a red flag to me in the sense that they didn't think enough of Afrezza to essentially become the novolog of the prandials. The physicians stiffening up fits very well within my thesis. SNY probably found out early on how much resistance there was to an inhaled insulin and knew it'd be an incredible uphill battle from the start. I've been saying from the beginning that I didn't think Afrezza was sandbagged as much as SNY didn't think it would have been worth the trouble to turn the tide and properly educate every physician about the benefits of Afrezza vs the misconceptions. Absolutely, just about any patient can get their physician to prescribe whatever medication they want, within reason. Obviously the drug has to match the symptoms. But any good physician will tell you their opinion on the matter, tell you why a certain drug would probably be better for you, but if you want a certain drug, it's not really up to the physician how to handle your care. It's also up to you. They should be willing to work with you as long as they feel you're understanding and well-informed about the dangers of doing things "your way". There is such thing as refusal of care... This would be a variant of that in my opinion. And yes, I still think Afrezza is the best prandial insulin out there. But it doesn't matter what I think... Not yet anyway. I highly doubt I'll go into either primary care or endocrinology, so it's highly unlikely I'll ever prescribe Afrezza (unless I do EM), but there is no debate from me that this is far and away the best prandial insulin on the market. Let's hope we can somehow gain momentum quickly enough in either the diabetic community or medical community (although hopefully both!) before we run out of money.
|
|
|
Post by stevil on Apr 7, 2016 14:56:36 GMT -5
I took some time out to do some research. media.mmm-online.com/documents/119/pharma_report_2015_29732.pdfLook at page 41, or for ease, control + F to find novolog/humalog. novolog and variants (1.9B +1.6B)= $3.5B in revenue in 2015 humalog and variants (1.7B + 1.4B)= $3.1B in revenue in 2015 now, here's the fun part. (not really. I get no fun from this... but I want to try to open eyes with it) If I'm reading this correctly, it says that last year $164million in sales for Apidra in 2015. money.cnn.com/news/newsfeeds/articles/globenewswire/10159901.htmSo let's look at this and ask ourselves, "who has the most to lose/gain?" SNY or Novo or Lilly? SNY has the most to gain and the least to lose. This essentially 100% nullifies the argument that SNY sandbagged Afrezza because they thought it would cannibalize their market share of Apidra. What market share?! Apidra is the joke of the town as far as RAAs go. If my numbers are correct, Apidra currently owns only 2.4% of the RAA market. Novolog currently dominates the market. If SNY saw any value at all in Afrezza, they'd have been fools to throw it away. This leaves me with the only conclusion (and again, just my opinion!) that the juice wasn't worth the squeeze to SNY. It wasn't worth it to them to sink in the money necessary to steal market share away from their competitors. Maybe it was the 65% profit sharing part that did us in... who knows? Again, I think the stronger argument isn't that they "sandbagged" Afrezza, but that they're letting it go to whomever else would want it. If they truly saw immense value in Afrezza, they wouldn't have allowed one of their competitors to scoop it up. I'm sorry if that seems negative to anyone else, but feel free to give a counterargument. If you're going to say that SNY didn't try to market Afrezza (not disputing that... they certainly didn't do a full scale launch), please give me reasons why they wouldn't have. Please try to make sense of why they'd allow Afrezza to fall to whomever wanted it. The longer I'm in this stock, the more it becomes apparent to me that we've got a thoroughbred dog that just won't hunt. The only people who believe in it are ourselves, but we're incapable of getting the drug to the finish line on our own. Stuck between a rock and a hard place...
|
|
|
Post by stevil on Apr 7, 2016 14:29:54 GMT -5
peppy et all,
The following is my opinion. I hope you choose not to take it personally or take offense to anything, although the following might be offensive.
There is no conspiracy going on with Afrezza. There are no paid bashers for this stock. There might be people who come on here with the intent to rile you all up because you're so passionate about Afrezza and some people really enjoy pushing buttons to get a rise out of people, but I can assure you, even if these minions existed, they're not nearly as plentiful as you think. These "FUDsters" would maybe gain a dollar for their efforts in the stock market if they caused you to sell your shares.
MNKD is where it is because Afrezza sales are lacking and we have no real cash flow, and currently, no communicated plan for how we're going to survive past the end of the year. Paid bashers would not be responsible for this. I know the sentiment here is that there is this massive campaign out to smear Afrezza, and while that might be partially true, it's not unique to MNKD. Every company has hit pieces against them. I think you all notice them so much more regarding MNKD because you follow this stock so closely. Every stock that I have followed in the past has people who complain about manipulation, hit pieces, MM corruption, etc. It's just the system we are forced to play in. Where there is money to be made, people will do what it takes to make money. MNKD had a target on its back from the start because the shorts correctly identified all the "FUD" early on. It was much clearer to them long ago than it is to some of us even today. Kudos to them for figuring it out. Shame on some of us for still being too stubborn to try.
I think it's dangerous to assume this massive conspiracy exists because it becomes the scapegoat for all the negative things about this stock. Facts and truths have been mislabeled as FUD instead of facts and truths. Sometimes people just express their opinions about things, especially analysts who get paid to do it. The trick is to dissect truth from lies, and so far the MNKD faithful hasn't done a tremendous job of that and the "FUDsters" have. The Street doesn't tell doctors how to prescribe. The Street doesn't tell diabetics not to be interested in inhaled insulin. The Street is the effect of both of those things, not the cause.
I'm not saying that this can't all change and we won't have our day in the sun. But I find that good information sometimes falls on deaf ears around here and it's really sad. This board has been interesting in the sense that people have assumed a battleground identity. It's an "us against them" mentality. You're forced to pick a side as either long or short and that stance defines who you are and whether someone will like you or not. You're not allowed to be a hopeful long with questions about how MNKD will solve this issue or that issue that are actually causing you to be a short because you're not seeing enough evidence of effective problem solving from management and/or a viable market for your drug. And heaven forbid, if you make a mistake or miscommunicate a point, you get eaten alive.
Ha, can't we all just get along? Can't we all have opinions and have civil discourse? Can't we exchange viewpoints and challenge each other with our assertions? I don't take issue with anyone whose viewpoint is different than mine as long as they have solid reasoning to back up their beliefs. I wish others felt the same...
|
|
|
Post by stevil on Apr 7, 2016 14:04:30 GMT -5
Don't know what other thread I should put this in and didn't want to start one just for this, but I ran into a 1st year pharm student on campus today and they'd said they'd learned about "this new inhaled insulin" in class recently. I'd asked if they'd been taught the PD/PK profile and they didn't seem to know much about it... I thought that was odd, but at least they're being taught about it in school! Even pharmacy school can't get us any added exposure beyond it's inhaled! Really need some studies!!!
|
|
|
Post by stevil on Apr 7, 2016 13:59:51 GMT -5
It makes sense to protect as much as you can, but is a rubber tip for the inhaler really valuable? Is this normal practice for device companies? I'm not really understanding why this would be a valuable asset to protect?
|
|
|
Post by stevil on Apr 7, 2016 11:52:07 GMT -5
Change the label, and you have a shot. If Dr's wont prescribe you think an A list celebrity is going to Endorse? If a celebrity endorsed (if that's even legal... I don't think the FDA allows that, otherwise you'd have athletes bragging about Viagra...oh wait ol Raphael Palmero did that so maybe you can ) more people would be interested in the medication and would ask their doctors to try it. I don't think a label change would be needed for that. Check out Steph Curry and under Armour. People quit buying nikes and went to UA simply because they wanted Stephs shoes. People follow their favorite celebs, even for comparable products. But it'd still be nice to get that label change Hanks should be aware of Afrezza. This is troubling news. I hope and wish for health upon him and for him to get on an Afrezza regimen
|
|
|
Post by stevil on Apr 7, 2016 11:46:37 GMT -5
Absolutely nothing in that article about Tom hanks being on afrezza I made the same mistake you did - thinking the OP said he was on it. Then when I read it again after being annoyed he wasn't on it, I realized they'd said "tell Hanks to take Afrezza" not that he was already on it...
|
|
|
Post by stevil on Apr 7, 2016 0:17:44 GMT -5
Yes, I made the mistake of not cross-checking my sources. I didn't think it would turn into this, otherwise I would have done so. I was incorrect and my source was not valid. To all who read this, the correct expiration for the Afrezza patent is 2023.
My point was that we may only have a limited lifespan for Afrezza of several years. The date wasn't really all that important. It may be in our best interest for Afrezza NOT to become a blockbuster. It may be better for us to be just under the threshold of profitability for a generic manufacturer to compete with us. I would imagine developing this technology would be fairly expensive so if the ROI isn't significant, we would never have competition.
I'm unsure if the patent protects from R&D or just sales, but I'm wondering if a generic manufacturer wanted to, if they could start immediately on cracking the code so to speak so that once the expiration is up, they could immediately sell the drug. It would kind of seem likely to me that this is allowed since generic drugs hit the market as soon as the patents expire for nearly every drug I'm aware of.
|
|
|
Post by stevil on Apr 6, 2016 20:58:56 GMT -5
I try to only be "sure" of the things I'm really "sure" about. If you try to be sure of things you're really sure about you shouldn't me making flat statements such as "The patent for Afrezza is only good until 2020," especially when your only source is an obscure Internet site that you "assumed" was correct. I was concerned that your flat statement might be true and am relieved that it's not. I was starting to worry you'd forgotten about me. If you'd have kept reading, you'd have seen where I stated later in the post you referenced that I wasn't sure about the patent date. I never claimed it was a certitude. That's the value of this board. To share information and see what others think. It's not productive at all to harass others. No one wants to read it and it's just a waste of everyone's time, mostly the moderators that have to read all our garbage. If I truly did worry you in any way, I apologize. I'd like to put our differences behind us and not get into it in every thread, so I hope you can help me make that not happen, again for the sake of our moderators and everyone else that has to read this. If you want to get into a sparring match, go ahead and pm me. I can't promise a timely response, but at least we can throw a few jabs back and forth for funzies. It is important to me to get my facts straight because I want to be seen as a credible person. If people choose to disregard my position, that's one thing, but I want to at least force them to think outside the box a little bit. But by all means, always do your own research. Don't rely on other people for that. I didn't think getting a patent date correct was all that hard for an online publication, but apparently they don't value their readers enough to get their facts straight.
|
|
|
Post by stevil on Apr 6, 2016 20:25:01 GMT -5
TA is useful for deciding when to make a trade. If you've done a fundamental analysis and decided to buy a stock TA helps when deciding which day to buy in and maximize your investment. You might pick up a few percentage points in your favor... On stocks like MNKD there is no fundamental analysis ...you can't look at profits or loses, growth, etc. All you have is a long term thesis. For example, rising diabetes rates around the world, then project out how big a piece of the pie (treating diabetes) Afrezza could capture. Basically we've been guessing and every long has been wrong. With no news coming out of MannKind (that's market moving) but an investor (me) with a desire to own shares (trade) to take advantage of its volatility TA is the only way to go. Looking at the TA and price action of MNKD today, MNKD is setting up as a potential profitable trade. If I like what I see in the first two hours of trading tomorrow I'll be buying. And if the stock recovers, I'll be selling when it looks overextended. If I do it correctly I could make 20% in a month (in this crazy stock). There are many ways to invest, buying Long, Shorting, averaging in, options etc. do whatever works for you. In response to the comment "TA is worthless with no news" I'd argue the opposite. MNKD has been sell the news. I don't want to day trade on news, I want a volatile range bound stock and news disrupts any pattern that I may find. In an attempt to save face, I agree with much, if not all, of what you stated above. I shouldn't have posted what I did because what I posted was incorrect and I'm far from an expert in TA. Having said all that, what I really meant to say was that with no news coming from Matt, that was actually what I would call "bad news". I think the technicals reflected that optimism and now (in my opinion) we'll be heading back downward... Hopefully things will change when we become oversold again, but I'm willing to bet that we won't see another solid wave up, if at all in the near term, until the next CC. But I'll tee this one up for my favorite crush and say that I'll stop posting in this thread before I make an (even bigger) ass of myself.
|
|