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Post by Deleted on Sept 29, 2017 19:19:52 GMT -5
I dont doubt the effectiveness of Afrezza. Nor do I not have a portion of my investable capital in the stock. I am a believer and a semi-long. 5+ years. I want to know if we should temper our expectations. Yes a change in label will bring some much needed clarity to Afrezza's unique drug profile. But in my opinion we will still be battling insurance companies, the stigma of inahling a drug, and the obvious: major paradigm shift in diabetes treatment. I believe that we are the cusp of our Apple stock moment, but just how much a label change will bring I really dont know. If I am wrong or missing something please comment. Thanks.
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Post by sayhey24 on Sept 29, 2017 19:37:58 GMT -5
For three years BP has gone around to every doctor and said afrezza is no good - just read the label. If you read the label and didn't know better you would probably agree. More important, if they get the ultra class this is a huge deal as it makes afrezza the standard for meal time insulin which no other insulin can match. As Joe Biden would say a BIG F'ing Deal.
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Post by Deleted on Sept 29, 2017 20:03:11 GMT -5
For three years BP has gone around to every doctor and said afrezza is no good - just read the label. If you read the label and didn't know better you would probably agree. More important, if they get the ultra class this is a huge deal as it makes afrezza the standard for meal time insulin which no other insulin can match. As Joe Biden would say a BIG F'ing Deal. This is a good point. But again my opinion, any worthwhile doctor would do some due diligence before writing off a product that has started to have these kinds of postive effects on PWD. In particular H1c's that mimic a non-diabetic. Furthermore, its not so much the bad mouthing of the drug, there has been little to none in terms of advertising. What was it. Less than 2% of the population with diabetes knows about the drug. Couple this with doctor's having to go out of their way to get patients an rx. Specifically, calling drug companies, writing letters requesting Afrezza due to special needs, etc. These have got to be taken care of before any major rxs sales will happen. |
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Post by dreamboatcruise on Sept 29, 2017 20:05:14 GMT -5
I dont doubt the effectiveness of Afrezza. Nor do I not have a portion of my investable capital in the stock. I am a believer and a semi-long. 5+ years. I want to know if we should temper our expectations. Yes a change in label will bring some much needed clarity to Afrezza's unique drug profile. But in my opinion we will still be battling insurance companies, the stigma of inahling a drug, and the obvious: major paradigm shift in diabetes treatment. I believe that we are the cusp of our Apple stock moment, but just how much a label change will bring I really dont know. If I am wrong or missing something please comment. Thanks. The pk/pd data has been available to doctors in the prescribing lit, so from that perspective I don't think a new adjective will change the way they view the pk/pd. Though some here have disputed the significance with regard to insurance, management has indicated that it will make a difference in getting better formulary placement. I'm giving them the benefit of the doubt that this is based on their actual discussions with payers/PBMs... hopefully that is not misplaced benefit of the doubt. And if we can ever afford to do advertising, I think it would be beneficial to say "the only Ultra-rapid Acting mealtime insulin." The changes they've requested also include clarifications about dosing/titrating. That could be important in assuring that more doctors have good first experiences with prescribing Afrezza. Who has a stigma about inhaling drugs... I see people using asthma inhalers all the time. |
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Post by letitride on Sept 29, 2017 20:13:41 GMT -5
I have presented Afrezza to many GPs and all of them recognize the PK/PD as a big fing deal! And all of them recognize the lack of insurance coverage as being a big fing deal!
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Post by cjm18 on Sept 29, 2017 20:40:45 GMT -5
For some reason mike is waiting for the label to "recapitalize" the company. Hopefully he has convinced creditors and investors it is a big deal so the most amount of money can be raised.
In short it's a big deal for afrezza and mannkind long term but not short term. Some longs are convinced it's a magic wand that neutralizes the awful balance sheet. Mannkind needs a lot of money.
I hope they dilute enough where they feel
comfortable hiring more reps and speeding up trials. That would be bullish to me.
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Post by matt on Sept 30, 2017 7:58:38 GMT -5
I have presented Afrezza to many GPs and all of them recognize the PK/PD as a big fing deal! And all of them recognize the lack of insurance coverage as being a big fing deal! I think that sums it up pretty well, and some are concerned about the "black box" warning as well. Any time there is a label revision, it gives the sales force something new to talk about with prescribing physicians who rapidly tire of the same old pitch from the same sales person. A change can only help open some office doors that are presently closed. However, I think changing the way the PK/PD is described in the label text is not going to change reimbursement. The PK/PD data has been out there since day one, and the adjectives used to describe it do not compel any insurance carrier to offer coverage or to move an already covered product to a higher tier. At the end of the day the top line of the label will still read "Afrezza (insulin human) Inhalation Powder" because fundamentally that what the product is. Afrezza is the only inhaled insulin, so it is already in a class by itself, but that has not resulted in coverage from most insurers. The fact that it is inhaled is precisely what gives the drug its faster PK/PD profile and this is no secret. The argument that insurance is required to cover all drug classes is not a good one, and isn't even true. When angiotensin receptor blockers were launched, most formularies did not cover them because there was an abundance of cheaper ACE inhibitors available even though ARBs have a better side effect profile. Now that amlodipine is generic, everybody covers ARB drugs but direct renin inhibitors remain uncovered for the most part. Three classes of drugs, three ways to treat hypertension due to overexpression of renin/angiotensin, but widely different coverage decisions. Insurance companies need to offer a treatment option for covered diseases and it would be different if Afrezza were the only insulin available, but all provide coverage for insulin in several forms and there is no additional entitlement to receive the best insulin. |
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Post by peppy on Sept 30, 2017 8:25:24 GMT -5
I have presented Afrezza to many GPs and all of them recognize the PK/PD as a big fing deal! And all of them recognize the lack of insurance coverage as being a big fing deal! I think that sums it up pretty well, and some are concerned about the "black box" warning as well. Any time there is a label revision, it gives the sales force something new to talk about with prescribing physicians who rapidly tire of the same old pitch from the same sales person. A change can only help open some office doors that are presently closed. However, I think changing the way the PK/PD is described in the label text is not going to change reimbursement. The PK/PD data has been out there since day one, and the adjectives used to describe it do not compel any insurance carrier to offer coverage or to move an already covered product to a higher tier. At the end of the day the top line of the label will still read "Afrezza (insulin human) Inhalation Powder" because fundamentally that what the product is. Afrezza is the only inhaled insulin, so it is already in a class by itself, but that has not resulted in coverage from most insurers. The fact that it is inhaled is precisely what gives the drug its faster PK/PD profile and this is no secret. The argument that insurance is required to cover all drug classes is not a good one, and isn't even true. When angiotensin receptor blockers were launched, most formularies did not cover them because there was an abundance of cheaper ACE inhibitors available even though ARBs have a better side effect profile. Now that amlodipine is generic, everybody covers ARB drugs but direct renin inhibitors remain uncovered for the most part. Three classes of drugs, three ways to treat hypertension due to overexpression of renin/angiotensin, but widely different coverage decisions. Insurance companies need to offer a treatment option for covered diseases and it would be different if Afrezza were the only insulin available, but all provide coverage for insulin in several forms and there is no additional entitlement to receive the best insulin. quote: and some are concerned about the "black box" warning as well. reply: they all have black box warnings. Here is one of my favorites:
"IMPORTANT SAFETY INFORMATION
WARNING: RISK OF THYROID C-CELL TUMORS
.Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether BYDUREON causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined
.BYDUREON is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with the use of BYDUREON and inform them of symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for detection of MTC in patients treated with BYDUREON" ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Quote: the PK/PD is described in the label text is not going to change reimbursement. The PK/PD data has been out there since day one, and the adjectives used to describe it do not compel any insurance carrier to offer coverage or to move an already covered product to a higher tier. At the end of the day the top line of the label will still read "Afrezza (insulin human) Inhalation Powder" because fundamentally that what the product is. Afrezza is the only inhaled insulin, so it is already in a class by itself, but that has not resulted in coverage from most insurers. The fact that it is inhaled is precisely what gives the drug its faster PK/PD profile and this is no secret.
reply: agreed, it is no secret. I for one believe physicians especially endocrinologists are able to understand this. Joey explained that ultra-rapid does not exist, it would be a new shelf. That makes sense. From your post I see your thinking is the potential new label will make no difference.
What is crazy about afrezza is it DOES work better. You are saying our medical system does not care. I am not surprised. One thousand plus people are members of this board. One thousand plus people here know medicine can not be trusted. More importantly Matt, you know. Do you get the screenings? Have you had your PSA taken today? What other screens are done routinely on men? Good thing you know as much as you do.
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Post by buyitonsale on Sept 30, 2017 9:26:02 GMT -5
Insurers will eventually come around because
Afrezza delivers things they want in the quality
of care measure improvement and ultimately
their bottom line:
Better A1C
Better medication adherence
Better outcomes
Mike has shown already that he knows how
to make progress on the contracting side.
Better label will will force insurers to take notice
and re-evaluate.
Good things ahead.
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Post by mnholdem on Sept 30, 2017 10:49:09 GMT -5
The comparison to an Apple moment brings home an important component of marketing a disruptive technology. You position your product in a way that consumers feel they must have it.
The CEO made it clear that his research revealed that 98% of PWD haven't heard of Afrezza. How MannKind markets Afrezza will be the key to growth. Steve Jobs created a marketing strategy that was brilliant. Consumers just HAD to have an Apple computer/iPod/iPhone. It was about lifestyle.
If Afrezza is marketed with lifestyle being the central message, MannKind has the potential of being phenomenally successful.
Apple didn't have to be prescribed or be covered by insurers. MannKind has more hurdles to clear, but Afrezza can still become a phenomenal success if the consumer patient recognizes how it will change their quality of life.
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Post by bones1026 on Sept 30, 2017 11:22:38 GMT -5
I have presented Afrezza to many GPs and all of them recognize the PK/PD as a big fing deal! And all of them recognize the lack of insurance coverage as being a big fing deal! I think that sums it up pretty well, and some are concerned about the "black box" warning as well. Any time there is a label revision, it gives the sales force something new to talk about with prescribing physicians who rapidly tire of the same old pitch from the same sales person. A change can only help open some office doors that are presently closed. However, I think changing the way the PK/PD is described in the label text is not going to change reimbursement. The PK/PD data has been out there since day one, and the adjectives used to describe it do not compel any insurance carrier to offer coverage or to move an already covered product to a higher tier. At the end of the day the top line of the label will still read "Afrezza (insulin human) Inhalation Powder" because fundamentally that what the product is. Afrezza is the only inhaled insulin, so it is already in a class by itself, but that has not resulted in coverage from most insurers. The fact that it is inhaled is precisely what gives the drug its faster PK/PD profile and this is no secret. The argument that insurance is required to cover all drug classes is not a good one, and isn't even true. When angiotensin receptor blockers were launched, most formularies did not cover them because there was an abundance of cheaper ACE inhibitors available even though ARBs have a better side effect profile. Now that amlodipine is generic, everybody covers ARB drugs but direct renin inhibitors remain uncovered for the most part. Three classes of drugs, three ways to treat hypertension due to overexpression of renin/angiotensin, but widely different coverage decisions. Insurance companies need to offer a treatment option for covered diseases and it would be different if Afrezza were the only insulin available, but all provide coverage for insulin in several forms and there is no additional entitlement to receive the best insulin. Matt- I apologize if I've missed this before, but I'm curious if you are a MNKD shareholder? Very knowledgeable guy, but not clear if you are an actual investor. Appreciate your input |
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Post by peppy on Sept 30, 2017 11:43:09 GMT -5
I think that sums it up pretty well, and some are concerned about the "black box" warning as well. Any time there is a label revision, it gives the sales force something new to talk about with prescribing physicians who rapidly tire of the same old pitch from the same sales person. A change can only help open some office doors that are presently closed. However, I think changing the way the PK/PD is described in the label text is not going to change reimbursement. The PK/PD data has been out there since day one, and the adjectives used to describe it do not compel any insurance carrier to offer coverage or to move an already covered product to a higher tier. At the end of the day the top line of the label will still read "Afrezza (insulin human) Inhalation Powder" because fundamentally that what the product is. Afrezza is the only inhaled insulin, so it is already in a class by itself, but that has not resulted in coverage from most insurers. The fact that it is inhaled is precisely what gives the drug its faster PK/PD profile and this is no secret. The argument that insurance is required to cover all drug classes is not a good one, and isn't even true. When angiotensin receptor blockers were launched, most formularies did not cover them because there was an abundance of cheaper ACE inhibitors available even though ARBs have a better side effect profile. Now that amlodipine is generic, everybody covers ARB drugs but direct renin inhibitors remain uncovered for the most part. Three classes of drugs, three ways to treat hypertension due to overexpression of renin/angiotensin, but widely different coverage decisions. Insurance companies need to offer a treatment option for covered diseases and it would be different if Afrezza were the only insulin available, but all provide coverage for insulin in several forms and there is no additional entitlement to receive the best insulin. Matt- I apologize if I've missed this before, but I'm curious if you are a MNKD shareholder? Very knowledgeable guy, but not clear if you are an actual investor. Appreciate your input mnkd.proboards.com/user/2019/recent The reason I mentioned Aug 16 as a possible date is because that was the last date to file a timely 10-Q. I don't know much about shorted stock, that is not something I am knowledgeable about, but I do know a bit about the bankruptcy procedures having been an expert witness in more than one case. There are a ton of disclosures that a company must make when it files for either Chapter 7 or Chapter 11, and that process is facilitated when a company does so on the same date as when they file their 10-Q or 10-K. It gives the company a clean set of financial disclosures to work from, and because the public was just notified up the updated financial status, it is a way to head off shareholder lawsuits for failure to disclose material information.
That said, there is nothing that requires filing on any particular date; only a requirement that the company meet certain legal definitions of bankrupt. In Delaware simply having a negative value for shareholder equity meets the definition, but that doesn't mean a company has to file for bankruptcy. There are lots of biotechs that have a hole in the equity section that recover nicely so meeting the legal definition is not the same as having to file. The other factor to keep in mind is that you cannot run the cash to zero and still have a Chapter 11 reorganization because there is a significant cost to Chapter 11 (unlike Chapter 7) so a decision to reorganize must be taken some months ahead of the real crunch time. Ultimately that is a judgment call the board has to make based on the deals that may, or may not, be in the pipeline, the financing promises that may, or may not, exist, market conditions for raising additional capital, and a host of other unknowable facts. That is why we have seen events like Dendreon declaring bankruptcy on the same day they filed their 3rd quarter 10Q even though they still had over $100 million in cash still on the balance sheet; that was a shocking event to most shareholders who did not see it coming.
I have said, and will say I again, that Mike has until September 30 to have a workable financing plan executed. October is usually a bad time to raise capital in biotech and I suspect this year will be particularly brutal for the sector as a whole and not just for Mannkind. If the money can be lined up by the end of September, that is very much preferable to pushing the decision later in the year when conditions may turn negative.
Read more: mnkd.proboards.com/user/2019/recent#ixzz4uBJKCuRq
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Post by boytroy88 on Sept 30, 2017 13:10:47 GMT -5
Matt- I apologize if I've missed this before, but I'm curious if you are a MNKD shareholder? Very knowledgeable guy, but not clear if you are an actual investor. Appreciate your input mnkd.proboards.com/user/2019/recent The reason I mentioned Aug 16 as a possible date is because that was the last date to file a timely 10-Q. I don't know much about shorted stock, that is not something I am knowledgeable about, but I do know a bit about the bankruptcy procedures having been an expert witness in more than one case. There are a ton of disclosures that a company must make when it files for either Chapter 7 or Chapter 11, and that process is facilitated when a company does so on the same date as when they file their 10-Q or 10-K. It gives the company a clean set of financial disclosures to work from, and because the public was just notified up the updated financial status, it is a way to head off shareholder lawsuits for failure to disclose material information.
That said, there is nothing that requires filing on any particular date; only a requirement that the company meet certain legal definitions of bankrupt. In Delaware simply having a negative value for shareholder equity meets the definition, but that doesn't mean a company has to file for bankruptcy. There are lots of biotechs that have a hole in the equity section that recover nicely so meeting the legal definition is not the same as having to file. The other factor to keep in mind is that you cannot run the cash to zero and still have a Chapter 11 reorganization because there is a significant cost to Chapter 11 (unlike Chapter 7) so a decision to reorganize must be taken some months ahead of the real crunch time. Ultimately that is a judgment call the board has to make based on the deals that may, or may not, be in the pipeline, the financing promises that may, or may not, exist, market conditions for raising additional capital, and a host of other unknowable facts. That is why we have seen events like Dendreon declaring bankruptcy on the same day they filed their 3rd quarter 10Q even though they still had over $100 million in cash still on the balance sheet; that was a shocking event to most shareholders who did not see it coming.
I have said, and will say I again, that Mike has until September 30 to have a workable financing plan executed. October is usually a bad time to raise capital in biotech and I suspect this year will be particularly brutal for the sector as a whole and not just for Mannkind. If the money can be lined up by the end of September, that is very much preferable to pushing the decision later in the year when conditions may turn negative.
Read more: mnkd.proboards.com/user/2019/recent#ixzz4uBJKCuRq
Guess we're past Matt's "d-day".... |
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Post by Deleted on Oct 7, 2017 8:09:32 GMT -5
matt "I think changing the way the PK/PD is described in the label text is not going to change reimbursement. The PK/PD data has been out there since day one, and the adjectives used to describe it do not compel any insurance carrier to offer coverage or to move an already covered product to a higher tier" Did the previous label show time of on-set and return to baseline for different dosages? So RAA that lingers for hours, increasing the probability of hypoglycemic events, is not a compelling reason?
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Post by Deleted on Oct 8, 2017 8:02:05 GMT -5
MannKind announced that the Food and Drug Administration has approved the label revision Afrezza, including for the first time since its 2014 approval demonstration of the “speed” at which Afrezza delivers insulin and manages blood sugar.
Speed is key: The label now includes the differentiated pharmacokinetic/pharmacodynamic (PK/PD) profile for Afrezza demonstrating linear kinetics. Both the 4-unit and 12-unit doses appear in the blood in one minute and reach effective (effects on insulin) levels in 12 minutes. Peak effects are reached at 35 minutes for 4 units and 45 minutes for 12 units with the 4-unit and 12-unit returning to baseline after 90 minutes and 180 minutes, respectively. The rapid action and exit should help patients not only better control mealtime sugar levels but also overnight hyperglycemia or Hypoglycemia.
Conclusion: The label revision is a victory for MannKind as the relaunch of Afrezza continues to build traction. With label claims highlighting Afrezza’s speed of delivery, rapid glucose control and rapid exit from the body, the 100-plus dedicated reps now have a new tool to engage and educate doctors and patients which should help drive adoption.
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