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Post by babaoriley on Jul 16, 2014 23:38:57 GMT -5
Simple math and logic, jpg, thanks.
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Post by alcc on Jul 17, 2014 0:24:38 GMT -5
jpg,
Good breakdown. Thanks.
We agree that (a) the t2 population is huge relative to t1; (b) under present practice, the vast majority of t2s are on oral only; (c) of those t2s who are on insulin, the majority are on basal only.
We also agree that the foregoing forms the submerged portion of our "iceberg." The above water, visible, quantifiable but small part of the iceberg is your unknown mix of t1 and t2 population who under current practice are on or will have been put on prandial.
My point is that to get to that vast submerged, untapped t2 market, it is necessary (but not sufficient) that we first achieve a significant share (of mind as well as prescriptions) of the "existing" prandial mkt (your A+B). You cannot bet on a paradigm shift re t2 treatment practice (your C+D) without having first unequivocally won A+B. In addition to giving the company the revenue ramp it needs in the near term, this is the only way to gain sufficient credibility and share of mind to effect our paradigm shift. This is why I said I hope Al is not betting on t2. And I don't think he is.
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Post by jpg on Jul 17, 2014 1:08:48 GMT -5
Hi Alcc,
My personal thinking is that the easiest market to tap is C (and even possibly part of D): C. Those 'end of the line type 2s' who are on a basal but really need a basal and a prandial but don't do it
Of all the patterns I see they (group C and part of group D) are certainly those I would give Afrezza to first. They should be on insulin but aren't. Pills will not cut it anymore (and we aren't even certain many pills do much go overall). Afrezza is so made for them... They have no other alternative basically. It is easier for an MD to prescribe something new when there is no alternative. It is easy to defend to oneself, to patients and to other MDs. This is how MDs prescribe stuff and feel ok about prescribing stuff. Observation of patterns of practice I think can teach us a lot of how drugs sell or don't. Another powerful reinforcer is when thought leaders give you the same message (see article by ADA posted yesterday in another tread). The ' beauty' (not from a publIc health point of view though...) of it all is that this is a huge group of patients. These patients are the 'moral equivalents' of the 'needle phobic' patients. They might not be scared of the needles per say but they certainly won't or can't take them (once a day and certainly not 3 times a day). This group overlaps into group D. Again without paradigms shifting as to how diabetics are 'optimally managed' these patients (independently of the other groups in my mind) will get a lot of Afrezza. Afrezza will optimally manage their diabetes for their particular set of circomstances. There are basically 3 choices for these patients: 1. the status quo of really bad glycemic controls and all it's complications. 2. Somehow getting them or forcing them to inject 'something': good luck with that. 3. Afrezza. Which is the path of least resistance for MDs, patients and third party payers? Afrezza. Again this is a huge market.
I assume that there will be a lot of self reinforcing positive feedback between prescriptions to different groups (A,B,C,D) and that patterns might be messy but I am confident we don't and won't need to 'conquer' one group at a time.
We will soon see!
JPG
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Post by babaoriley on Jul 17, 2014 1:14:18 GMT -5
Agree, jpg, we just need to get a quarter or so of sales to get the whole thing going; sales should spread like a nuclear chain reaction. When that first quarter will actually be is a good question. Management is hoping first quarter of 2015, right? I'd settle for second quarter, with a hopefully strong, enthusiastic partner along, and a guy like Don Draper coming up with an ad campaign!
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Post by jpg on Jul 17, 2014 1:24:06 GMT -5
Don't know when the first quarter will be either but the ADA article is better then what the vast majority of big pharmas could do. With expert opinion on our side an average BP (Lilly even) will do wonders. Don Draper of BP would change the medical standards in a few short years. Hope we get Don Draper! He was on the 50s-60s so sadly he probably retired?
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Post by brentie on Jul 17, 2014 8:19:41 GMT -5
JPG, I think Al agrees with you... That sounds pretty magical. Does this work for Type 2s only, or is it an option for Type 1s now taking basal and bolus insulin? Al:Both could use it. Afresa is for prandial control – mealtime only – not basal doses. For about 70% of Type 2s, all you’ll need is a regular set dose of Afresa. This will work for everyone except the “late-stage” Type 2s, who will need to take basal insulin as well. It’s different for Type 1′s because there’s a very big therapeutic window for them; their insulin needs are so differing. They can use Afresa to cover meals, yes, but they’ll still have the issue that if they dose and don’t eat anything, they’ll get hypo, and if they eat a large meal, they’ll need a larger dose. The advantage for all patients is that they won’t have to do carb counting or anything, because Afresa does not have to be so precisely matched to food intake. Aren’t most Type 2s currently treated with a basal insulin only, instead of mealtime dosing? Al:Yes, but that’s the wrong way around. The correct therapy should be a good prandial insulin and not long-term insulin — Afresa in particular because it turns off glucose production and delivery from the liver. Our latest trials of 600 patients are showing even more significant benefits from the product than our original trials; the most recent trial appears to show that this should replace frontline treatment for all Type 2 patients. www.diabetesmine.com/2009/11/the-truth-about-afresa-inhalable-insulin-a-chat-with-al-mann.html
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Post by alcc on Jul 17, 2014 11:10:45 GMT -5
jpg,
You would be right if everyone (drs, patients, ADA etc.) all aggressively, rationally adopt Afrezza as frontline treatment for t2. I hope you are right!
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Post by babaoriley on Jul 17, 2014 12:05:10 GMT -5
jpg, You would be right if everyone (drs, patients, ADA etc.) all aggressively, rationally adopt Afrezza as frontline treatment for t2. I hope you are right! Won't happen overnight, but eventually and sooner rather than later, a good enough percentage for our purposes will adopt Afrezza.
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Post by seanismorris on Jul 17, 2014 12:35:32 GMT -5
Re
Aren’t most Type 2s currently treated with a basal insulin only, instead of mealtime dosing?
Al:Yes, but that’s the wrong way around. The correct therapy should be a good prandial insulin and not long-term insulin — Afresa in particular because it turns off glucose production and delivery from the liver. Our latest trials of 600 patients are showing even more significant benefits from the product than our original trials; the most recent trial appears to show that this should replace frontline treatment for all Type 2 patients.
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I agree with Al. Eventually, Afrezza should be a frontline treatment for Type2. The problem is the Clinical Trials focused on adding Afrezza to a basal regimen. There really needed to be a trial for pre diabetics and for people that have never used an insulin before... But logically prescribing Afrezza earlier makes more sense. One theory is taking insulin is a major part of what causes the progression of the disease. So, what is needed is a minimalist approach; as little insulin as possible to avoid the adverse events. The time in which patients are in the most danger is around mealtime, so that's where to start. Eventually, everyone will need a basal insulin but delaying that, I think should be a priority. Obviously patients with a more advanced stage of diabetes requires both.
Marketing wise, it may take a year or two before doctors are comfortable prescribing a mealtime before a prandial (because the way the trails were performed) but they will get there. And, for investors that's when our faith will be rewarded. That's when I predict we will have a buy out. (Once that trend is established, but before it becomes standard practice)
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Post by alcc on Jul 17, 2014 12:48:31 GMT -5
Good news is, label says must be used with basal for t1, but is silent on t2. So no fda roadblock there! Just need to overcome defensive practice hewing to "std of care."
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Post by brentie on Jul 17, 2014 13:24:34 GMT -5
"I agree with Al. Eventually, Afrezza should be a frontline treatment for Type2. The problem is the Clinical Trials focused on adding Afrezza to a basal regimen. There really needed to be a trial for pre diabetics and for people that have never used an insulin before..." Sean, the Type I trial included a basal, the Type II trial didn't and consisted of people who were failing on orals and hadn't yet used insulin. One group got Afrezza and the other got a placebo. Purpose: Insulin-naive subjects with Type 2 Diabetes Mellitus will have either Prandial Technosphere® Insulin or Technosphere Powder (placebo) added to their oral antidiabetic drugs. www.clinicaltrials.gov/ct2/show/NCT01451398?term=mannkind&rank=46
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Post by seanismorris on Jul 17, 2014 13:51:16 GMT -5
Brentie thanks for the correction.
I was thinking of Afrezza before everything, including Metformin and other oral medications. (Misspoke)
In reality it may be Metformin then Afrezza for patients with pre-diabetes moving to full diabetes.
In my mind, when I think of full diabetes I think of people that need insulin injections....
The cut offs aren't very clear for the stages of diabetes (at least I haven't seen them) and may be different patient to patient.
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