|
Post by stevil on Nov 21, 2015 21:36:01 GMT -5
Confession: I like Stevil's posts. Good writer, with thoughtful consideration to the difficulties that are increasingly clear. Thanks, kball. It's nice to know I'm contributing... To someone...
|
|
|
Post by stevil on Nov 21, 2015 18:40:14 GMT -5
stevil, if MNKD was served with the notice they were exiting the agreement, MNKD would be required to file an SEC disclosure immediately. Just an FYI. Thanks for sharing. I wasn't aware this was the case.
|
|
|
Post by stevil on Nov 21, 2015 18:34:02 GMT -5
@ Stevil You invested in Afrezza why? SNY can state that Afrezza works quickly and exits quickly...there is much THEY can hang their hats on. But judging from some of your previous posts I find it odd that you invested in MNKD. Just my take. You have a good point about the PK/PD profile- they have that listed on their pro website, so it appears they are already sharing those details with professionals. The label change was more for better tier coverage and to make more convincing claims. They need to be able to use language like "superior to other rapid acting insulins (super rapid acting would be phenomenal), reduces hypos compared to..., has shown to reduce A1C better than..." Those are the things that are going to make Afrezza more marketable. I invested for most of the same reasons that have been shared over and over on here. But I knew trouble was on the horizon after the summer CC, but by then, it was too late as I timed my entry point poorly. I'd been watching MNKD for a while and thought the time had finally come where there were enough positive events on the horizon to not only justify its price, but also point to gaining momentum to go considerably higher. I would have taken my losses after the call but I didn't think MNKD would get beat down to near bankruptcy this quickly nor did I think it would take this long to get another application announced. Maybe I need to go back and read all my previous posts because I've been called out by a lot of different posters on here and I'm not sure why. I've been honest that I'm a long investor, and holding, but that I won't be adding to my position until considerable momentum builds either with Afrezza or a promising new application. I won't ever short this stock because I don't want to hurt the company, but if I had to choose between the two, I would probably admit that I'm currently short. I don't think we have enough time to turn this around, barring some huge impending announcement, but I am hopeful and eager to see if it can happen. I've spoken of both the positives and negatives of MNKD, but I call it like I see it. Right now, there are significantly more negatives than positives. I don't understand why it's forbidden to have a negative opinion of a company that is clearly having issues. It's not like I'm making stuff up or trying to perpetuate false, slanderous rumors. I share what I know based off my experience in healthcare, patient care, and insurance claims. I'm just trying to help people understand the issues Afrezza is facing a little better. My personality is such that I'm always seeking out the "why". I knew it would take a long time for MNKD to really take off if it was going to. I just didn't think I'd lose so much waiting for it to happen. I also didn't expect Afrezza to take so long to gain traction. I was hoping the label would be changed by now, insurance would be figured out, and TV ads would have started.
|
|
|
Post by stevil on Nov 21, 2015 17:49:42 GMT -5
Sorry mods for all the discussion...
That's what I don't get though. What is SNY's plan?! Afrezza is an FDA-approved, viable drug, that's getting amazing results. While I understand they have first priority for acquisition of Afrezza rights, why would they sandbag it? Work on the label, get it changed, if you can't, lower the price and let word of mouth speak of the things the label can't. But they've spent all this money bringing Afrezza to market to leave it at the 2 yard line?
Wish we had access to SNY's war room. They're either negligent, stupid, or being patient while the trials are completing. Just wish we knew which it was.
|
|
|
Post by stevil on Nov 21, 2015 17:25:46 GMT -5
The label change really needs to occur before marketing makes sense.
My uncle, who has been DM1 for about 60 years, said that he'd read about Afrezza in one of his magazines. His impression after reading about it was that it was INFERIOR! to injectable insulin. I was extremely surprised to hear him talk about Afrezza that way because he's an intelligent man. The information being presented to diabetics/docs should not even be able to leave doubt as to which product is superior.
My uncle shouldn't have needed to spend more than 3 seconds without at least being told that Afrezza is better than everything else out there. SNY can't do that until the label gets changed. Until that happens, Afrezza will just blend in with the rest of the prandials. The only characteristic SNY can use to distinguish it right now is that it's an inhaled insulin, and we saw how futile that was to market with Exubera. Afrezza doesn't even get rid of the finger pricks, so it's not like it's painless compared to its injectable counterparts. While all here probably know that inhaling Afrezza allows for virtually immediate uptake into the bloodstream, the general public does not make that association. They think that injecting a liquid into your body should put that medication directly into your bloodstream. Then there's the hexamer/monomer thing. Who here knew what that was before doing their DD on Afrezza? I wouldn't know unless I was a biochem major...
Another thing to consider- Docs get inundated with new drugs all the time. There have been few true advancements in drugs over the last several years. New drugs are typically just older generics with fewer/reduced side effects. For most people, it's not worth paying brand price for slightly milder side effects. And docs generally won't even prescribe new drugs unless it's clear the patient would benefit from them. And that's assuming said docs stay on top of their education to stay current on new drugs. People want to criticize docs for taking hand outs, and even pharma companies for doing it, but it's sometimes the only way to get a doc's attention and loyalty in prescribing drugs. There are just too many options and not enough time to properly analyze the benefits of each. While docs are also chemists to a degree, most don't want to mess around with learning thousands of drugs. They want to see and treat their patients. So they prescribe what they are familiar with and what they know works. That's why it's so crucial that pharmas get docs attached to their drug. As long as it works well for the majority of patients and patients don't complain about the cost and ask for a cheaper alternative, docs will likely stay loyal to that drug.
|
|
|
Post by stevil on Nov 21, 2015 14:05:30 GMT -5
I believe the dynamics of the medical profession have more to do with Afrezza's very slow uptake than any marketing or insurance issues, although insurance does remain a critical issue. "First, do no harm." That means using the proven approach and not the "new and improved treatment." Again I point to Clostridium difficile and fecal transplants as a parallel case. There are approximately 500,000 cases and 15,000 deaths from this condition each year in the US. The treatment would be about as difficult to standardize as blood transfusions. A trial of the treatment was halted because it was found to be over 90% effective, and it would be unethical not to offer to all patients in the study. Many of those treated have been suffering for years, and they are cured in a matter of days. Yet few doctors offer the treatment. It is hard to get insurance to cover it. Like Afrezza, it is considered primarily for those who have failed other treatments and never as a first line treatment. Today in the US alone 50 people will die and 1,500 will be diagnosed with C. diff. Most could be quickly cured with fecal transplants. The way these transplants work and why antibiotic treatments are really the cause more than the cure is now well understood. But "first, do no harm" results in the inertia of the standard of care. I now better understand why my physician/investor friend considers "unmet needs" the holy grail of biotech. When there is no other treatment available the medical community is much more willing to try something new. And the only way to be sure a new treatment doesn't have long term side effects is to wait 10 or 20 years and see what happens. And in the case of Afrezza, remember, it is a logical impossibility to prove the negative case, that something does not cause cancer, for instance. ...and yes, there is the lung function test as well. It is always faster, easier and safer (for the doctor) to stick with the old rather than trying the new and improved. Agree completely with the above. I try to speak with as many GP's/IM/Endos that I can about Afrezza. Only a few have heard of it. But their attitude towards it is, "I'll try it once it's been proven safe and adopted by the larger community". Few docs are risky/adventurous/cavalier, whatever adjective you want to use, to try new methods unless they have no other option. The practice of medicine (again from all the docs I've rubbed shoulders with, which may not be a fair representation of the whole medical community because I was privileged to work at a world-class hospital that was extremely conservative...) seems to have a more conservative approach. A bird in the hand is worth two in the bush. It's better to use what is known to be safe and effective, even if it might cause more harm 20-30 years down the line. What's better, to suffer from known causes like neuropathy 40 years down the road or to potentially have lung complications and die a very painful death in 5-10 years... or however long? My fear is that it may actually be to our detriment that we showed up to the party first. Al Mann was the pioneer that provided technosphere that someone else may reap the benefits of long after MNKD is gone. Like you said, we may need to provide a product that no one else has in order to force the adoption of TS particles. And based off mssciguy's post, I'm beginning to wonder if Hakan was let go because SNY will notify MNKD of their JV termination in Jan 2016. It would make sense with the timing and why it was so sudden... Wasn't it only 90 days that they needed to give MNKD? Like the rest, I'm getting tired of speculating though. I guess we'll find out soon enough!
|
|
|
Post by stevil on Nov 21, 2015 13:42:17 GMT -5
I'm either going to be very wealthy or very dumb. I still don't get the reasoning behind the above. I can see my investment in MNKD doubling or tripling in the next few years, which will not make me "very wealthy," but will still have been a good investment. I think it's because there's not much chance that MNKD sticks around if it only produces niche products. It's a completely different administration method than what is currently available for most drugs. So its potential is most likely boom or bust. Either doctors/patients adopt the new method (which, by all indications, should be vastly superior for some drugs- most notably pain) or MNKD will go bankrupt. Sure, there's a chance that it can merely survive, but I think most view it as an all or nothing. And it does make sense if you think about it.... We don't have enough cash to be just one of the other guys. Our technology likely requires more R&D than a tablet/capsule because of its innate complexity.
|
|
|
Post by stevil on Nov 21, 2015 1:14:09 GMT -5
Technosphere can encompass a huge range of atomic weights. Dreamboat may be perfect for insulin. Sanofi may need a different inhaler for optimal performance for the next Technosphere project they are working on. Disclaimer: I'm not an engineer. I don't think that's an accurate statement, though. When you're talking about microparticles, atomic weights matter very little, so long as they are still aerodynamic enough to reach the alveoli of the lungs. All the dreamboat does is provide a mechanism to get medication into the lungs while attached to FDKP. FDKP is such a small molecule that it wouldn't require a different device to maximize its concentration in the lungs- the dreamboat would be more than sufficient. The capillaries in the alveoli, where blood/gas exchange occurs (and where the medication would be absorbed) is only the width of a red blood cell, which is 5-7 microns. Meaning, if the attached molecule is so big that it would require a different device than the dreamboat, it's probably not a good candidate for inhalation ha.
|
|
|
Post by stevil on Nov 20, 2015 17:15:35 GMT -5
There is always the very real possibility, even though in the past I have had a really hard time accepting this, that Sanofi is on his way out. Hakan not having been able to negotiate a single Technosphere deal, is not the most indicated person to renegotiate an Afrezza deal. Yes, more speculation to add to the fire, but unfortunately that is all we are left with. One thing is not speculation anymore, but mostly true is that the situation in MNKD, other than for that glimmer of hope that happen when we got approval and partnered up, is much much worst than I thought possible. Whether Mr. Mann will be able to turn it around or not is anybody's guess, but it is starting to look more and more as a failed enterprise. I said it often, if it was not because Afrezza works I would not be hanging around. Now I am even starting to question if they will be ever able to take advantage of it, or if the most likely outcome is someone coming along, buying it for cheap, and making a fortune after taking over. What I do know for sure is that this is bad all around. So you think Al would sell out on the cheap and take a big loss on his investment? the only issue I have with this is it would not be kosher (oh geez) to list on the TASE and screw his kin over. If Al was going to liquidate the company, the TASE listing doesn't make sense, does it? I'm beginning to think Al was starting to get restless awhile ago and began getting more and more involved, leading to the TASE listing. I think Al is doing everything in his power to keep this thing afloat. He's already stated that his family is set financially and he's going to donate whatever excess income he has when he dies to charity. I think he's going out swinging on this one... he's really got nothing to lose. JMO.
|
|
|
Post by stevil on Nov 20, 2015 16:27:33 GMT -5
I think it's premature to presume that Hakan was given a choice of resign or be fired. After all, Hakan has been there like 10-15 years already, so firing him now is a bit like calling the fire department after the house has burned down. Plus, as I understood it, he was Al'Mann's personal choice to be CEO back when he was originally hired and also when Al retired. Also, why fire him -- as opposed to finding a new CEO and then just replacing him? Then the news might have been perceived in a more positive light. As it is, with no explanation coming from the company, all investors see is that the ship has lost its captain. Al, while great, is still 90 years old and even though only "interim CEO," investors are bound to wonder if he is up to handling MNKD's current situation. So I think one, at least, should reflect on the possibility that Hakan resigned because he either didn't like getting blamed and taking fire from critics -- perhaps for things over which he had no control over -- and/or, possibly,he didn't like what he saw looming on the horizon. Then it was the correct decision for him to make if he didn't like what was looming on the horizon. I don't want a quitter as our CEO. A Captain (good leader) is the last person off the boat in a crisis. They don't abandon ship when they see rough waters on the horizon. That is when their expertise is most needed. The only reasons I would be ok with Hakan stepping down on his own would be for medical/ethical reasons, or he realized he wasn't giving MNKD what it deserved. Granted, I'm not in the know, but considering the state of the company and no rumors of any health issues and knowing how ethical Al is, I can't help but think he was pushed out.
|
|
|
Post by stevil on Nov 20, 2015 16:05:21 GMT -5
Honestly, this thread baffles me.... IMO,,,, there's only one way to look at this as a positive event. That is if you already believed the ship was sinking and Hakan was driving it all along. I never saw it that way... I always looked at Al stepping down and giving Hakan the CEO roll as a sign that the details were done and Hakan, specializing is the science, could run the operations on Al's path without having much he could fuk up. Otherwise, I never would've seen Hakan as the right choice for CEO in the first place, AND how the hell did Al ever think he was??? Today's news confirms to me that the train is off the rails.... I was going to essentially post just this, except spun the other way. The only people who view this as being negative are those who weren't in tune with how bad our situation really was. They didn't realize that the ship was sinking with Hakan aboard. To me, while it isn't a completely positive thing... yet- like others have iterated, it at least gives us hope to succeed. In other words, it's not the decision that's negative, it's coming to terms with reality for some on here. To me, this can only end positively, as I was convinced there was only one direction Hakan was taking us. And now we have a new chance to turn the ship around...
|
|
|
Post by stevil on Nov 12, 2015 16:17:55 GMT -5
Ya, I'm trying my best to tone it down a little, but it gets difficult for a couple reasons. First, I get defensive, but then it gets fun messing with people after a while. PM me and call me out though if I ever step out of line. I'm really not a bad guy and I want to contribute all the knowledge I already have and all I'm acquiring to this board. I gave you the benefit of the doubt when I came to your defense the first time I saw others attacking you in a personal way, but now my sneaking suspicion leads me to believe you may have previously gone by a different name on this board(?). If you are this former poster you may want to just back away from the board slowly before you are booted off again. Just word to the wise. Nope, joined for the first time back in June, I believe. And I don't pretend to be anyone but myself. It's unfortunate that so many trolls exist on message boards. That's truly not my intent. II suppose I'm a polarizing character. I've had pm s both thanking me for being here and others telling me to piss off. I do my best to get along with everyone but for some reason that can be challenging here.
|
|
|
Post by stevil on Nov 12, 2015 15:53:48 GMT -5
It does seem weird that they handled the debt by paying cash... But, I really always do fallback on what we don't know. Look at it this way, my companies don't have billion dollar market caps, but I also don't telegraph our moves to anyone, whether it be the competition, the market etc. Its not hard to see why MNKD doesn't announce every single thing they are doing. They have a huge target on their backs. I love how they didn't respond yesterday to AF. Yeah it shook the market, but by not responding to that piece of garbage they set a precedent that they're not going to get involved in this garbage. We don't know whats going on behind the scenes. I'm totally cool with that. I am confident that everyone involved in this company, whether it be SFY, Matt, Hakan, etc aren't f'ing around and trying to waste money and time. Sanofi partnered for a reason. The slow rollout doesn't seem strange to me, in fact, it seems smart for all the reasons that have been beat to death on here. That hasn't changed for me, as the paranoia of the market changes. Its what keeps me calm when everyone else is selling. We still have plenty of time for this to work out. Al is not going to let this company go BK. Let Fuckstein and his friends suck each other off and spin BS. sucks if you get caught up in it, but if you do your DD, like the a lot of others on this board have, then you can be confident. Science is great, diabetes still exists, ask a diabetic you know if they would rather use a needle or a faster acting inhaler. lets let the companies that have made multi billions for themselves marketing pharmaceuticals figure out when to release an ad and how to educate doctors. you know, their job. There are strong cards both MNKD and SFY are holding close to their chest. Because we don't see them doesn't mean they don't exist. But the dips. breathe. Have a great day! Agree with everything you said, Mannkind Management is doing a great job IMO. Look at the difference in shareholder morale between yesterday after AF blatantly lied, and today. That was Management !!! They handled it beautifully. EOM I'm starting to post too much again so I'll cool it after this, but I want to give managment props for this move and do so publicly for all to see... I've been one of the hardest on them and I'll eat a little crow. Let's hope they can keep it up... Wouldn't mind eating crow for a while...
|
|
|
Post by stevil on Nov 12, 2015 15:52:08 GMT -5
Steevill - your 'objective' opinion annoys some. As long as it is anchored in reality I find it absurd to not listen. You don't have the ability to influence my holdings. And so far your posts are abrasive, but your points aren't easily discredited. theres A LOT of noise on this site. Especially of late. whatever. bring it. Ya, I'm trying my best to tone it down a little, but it gets difficult for a couple reasons. First, I get defensive, but then it gets fun messing with people after a while. PM me and call me out though if I ever step out of line. I'm really not a bad guy and I want to contribute all the knowledge I already have and all I'm acquiring to this board.
|
|
|
Post by stevil on Nov 12, 2015 15:48:23 GMT -5
This is the most fascinating stock I've ever held, Sherlock Holmes himself wouldn't be able to figure out the next move. Hopefully Al is our Holmes. I was thinking maybe we can get some of the best known authors to write a book on Mannkind's history so far. Perhaps we can have another blockbuster like "Barbarians at the Gate" or "The Great Short". Maybe a film will be made someday as well. Mannkind's history is so intriguing, with interesting characters like Martin Shkreli, Adam F and the insider trading at FDA. One candidate I am thinking of is Barry Werth, who wrote "The Antidote: Inside the World of New Pharma" and "The Billion-Dollar Molecule: The Quest for the Perfect Drug", both were about Vertex, a bio-tech company. It really is bizarre to me how such a small company can garner so much attention. And be stocked with fanatics on either side. This truly is a battleground stock and I'm not really even sure why. New, disruptive medications come out all the time. What gave MNKD the target on its back?
|
|