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Post by Chris-C on Nov 21, 2015 13:07:06 GMT -5
The interesting thing about the "Afrezza saga" is the new "breaking bad" conspiracies that pop up regularly. Perhaps some of these suspicions are true, but then again, perhaps Sanofi genuinely recognizes the benefits and long term revenue potential of Afrezza. After all, they pocket 2/3 of every revenue dollar and they have millions in "sunk costs" invested already. This is to say nothing of the multiple legal risks associated with being caught perpetrating such clandestine strategies. I prefer to think that because systems are always perfectly aligned to get the results that they get, the current situation is best explained through a complex array of several factors, many of which are mentioned in this thread. Every once in awhile things go wrong despite honest, good faith attempts directed toward making them successful.
JMHO
Chris C
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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! |
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Post by slugworth008 on Nov 21, 2015 16:42:59 GMT -5
mssciguydecisionresourcesgroup.com/sanofis-diabetes-alliances-third-or-fourth-times-the-charm/ This may be a must read for those of us who don't know what a challenge the spirometry still appears to be, and those of us who don't know how confused Sanofi appears to be in it's current approach to competition in the Diabetes space globally. --------------------------------------------------------------------------------- We can thanks the jack wagons at the FDA for what should have been an unnecessary test. (IMO) And bottom line is IF enough patients start asking for Afrezza the docs will get off their assets and handle the damn testing. Benefits and awareness - Once again that 'ol "Real and effective marketing thingy" just keeps popping up.
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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.
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Post by slugworth008 on Nov 21, 2015 17:46:41 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.
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Post by fedakd on Nov 21, 2015 17:50:00 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.
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Post by jurystillout on Nov 21, 2015 17:55:20 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. |
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Post by jurystillout on Nov 21, 2015 18:00:38 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. Not taking a position on what sny will do however I'm not aware of any requirements originating from the SEC that would mandate the mnkd disclose this information immediately, fedakd, could you please reference the source of this mandate? |
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Post by ezrasfund on Nov 21, 2015 18:04:08 GMT -5
"Find out if you're eligible for a $0 co-pay for your first prescription*. After that, pay no more than $30 for each prescription refill through December 2016. Afrezza® is not right for everyone, so it's important to speak to your healthcare professional to learn if Afrezza® may be an option for you." www.afrezza.com/meet-afrezza?=ca1234Just sayin'. |
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Post by hankscorpio7 on Nov 21, 2015 18:15:36 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. They can state that, but can they state and prove it is superior to current therapies? Reason MNKD is where it is. Isnt it odd though? But Stevil is not new. Many have posted the same thoughts since the partnership. Judge me by my posts do you? We are speculators, we kick the tires and look under the hood. There are only speculators in MNKD- at this point. |
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Post by suebeeee1 on Nov 21, 2015 18:17:41 GMT -5
"Find out if you're eligible for a $0 co-pay for your first prescription*. After that, pay no more than $30 for each prescription refill through December 2016. Afrezza® is not right for everyone, so it's important to speak to your healthcare professional to learn if Afrezza® may be an option for you." www.afrezza.com/meet-afrezza?=ca1234Just sayin'. This is patently not true. IF your insurance covers Afrezza, you MAY be eligible for a $0 co-pay on your first prescription after that, IF and only if you have insurance, will you pay no more than $30 per prescription. If your insurance is one of the more than 60% right now that does not cover Afrezza, then you pay full price minus the maximum $150/prescription that Sanofi is offering. So, if your prescription is the average of over $400/month, you will pay at least $250/month, beginning with the first month if you have one of the insurance companies not covering Afrezza. I don't think it helps anyone to claim that they can get their drugs this cheaply as long as we have this huge insurance disconnect. If you make this claim, at least tell people this is if their insurance company covers it. I think we make long term haters when we tell them that their prescription is only going to cost $30 and they get a bill from the pharmacy for $250! Most people will hand it right back to the pharmacist and get their old prescription refilled. Then how long do you think it will take for them to try Afrezza again? |
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Post by ezrasfund on Nov 21, 2015 18:31:36 GMT -5
I agree, suebee. It's in the fine print, "co-pay." I was just pointing to the "through December 2016." Then Sanofi will pull the plug if things aren't moving IMO.
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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. |
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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. |
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Post by suebeeee1 on Nov 21, 2015 18:54:12 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. Relax...take a deep breath. We welcome the good, the bad and the ugly (we do not want AF posting here however). This stock will recover and we will have a winner, with or without Sanofi. Afrezza....just breathe! |
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