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Post by compound26 on Mar 9, 2017 17:17:15 GMT -5
www.afrezzajustbreathe.com/tv-news-report-on-afrezza/www.tudiabetes.org/forum/t/afrezza-question/59564/10?u=charles5Inhaled Insulin Is Quick & Easy To Use, But Is It A Game-Changer?
March 8, 2017 5:45 PM By Dr. Maria Simbra pittsburgh.cbslocal.com/2017/03/08/inhaled-insulin-is-quick-easy-to-use-but-is-it-a-game-changer/PITTSBURGH (KDKA) – Could insulin that you inhale, instead of inject be a game-changer for diabetics? For some people with diabetes, injecting insulin is the only way to keep their blood sugars under control. What if there was another way? “When you inhale something, it gets in the body very quickly, and works very quickly, and then goes away quickly,” Dr. Wayne Evron, a diabetes specialist at St. Clair Hospital, said. Inhaled insulin is a quicker, easier way to get the medicine into your body. People get less of a spike in blood sugar after eating. Inhaled insulin came about six years ago, and has undergone some refinement. The initial versions were linked to a decrease in lung function at six months, and had to be taken off the market. Even with the current version, doctors have to watch carefully how well the lungs work. “Even now, any inhaled insulin, you still have to make sure they don’t have COPD or any other lung problem. And, you still have to measure lung function before and during. So, that’s a deterrent a little bit to doctors,” Dr. Evron said. The device looks like an inhaler. You insert capsules of insulin in different doses, depending on your needs based on blood sugar readings. “There are some preparations you have to do. You have to put a capsule in the bottle, you have to measure it right, not that you don’t have to measure insulin, but it’s a little more involved,” Dr. Evron said. “The advantage, I guess is that people don’t like to take shots.” It tends to be more popular with his younger, more tech savvy patients. But even so, it isn’t for most of them. “We live in Pittsburgh. And, there’s a lot of COPD both from smoking as well as pollutants,” Dr. Evron said. It’s also about double the cost of injectable insulin. “Very few insurances are paying for it now. Because it’s very expensive,” Dr. Evron said. There are a few case reports of cancer. “It’s irritating. Insulin is a growth hormone. So, when you put insulin in the lung, there’s always that fear that you get growth of lung tissue as well,” Dr. Evron said. It also may not work well in the long run. “It’s in a foreign place. So, the body attacks it. So, there was some worry about anti-insulin antibodies forming from this. So yes, the question is this could become less effective with time?” Dr. Evron said.
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Post by compound26 on Mar 8, 2017 18:12:35 GMT -5
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Post by compound26 on Mar 7, 2017 17:39:39 GMT -5
The rumor is.....they are talking about medical pot:-))) Don't ask me to drive over there because if I say yes, it will for sure get canceled! Lol Huh. Can you elaborate miss Rancho  .. Who is talking about pot.? |
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Post by compound26 on Mar 5, 2017 18:40:43 GMT -5
"He (Mike Castagna) has been here long enough that he could have personally gone out and sold more scripts than are selling now." Well said, Falcon! All these are without efforts from MNKD (their own research, or word of mouth by people here). So, what exactly is MNKD and its employees are doing? I know they are working with insurance, etc.. But, Drs are not prescribing and patients are not asking. Why keep on trying to build the support structure when no one is coming? I know support structure is important, but MNKD doesn't have time and money to wait out. They have to start selling and bringing money *yesterday*.. I'm sure, if all the 60-70 FTE camp out at one or two Drs who are OK with prescribing Afrezza, and educate all their patients one by one and manage them *by hand* day to day, we will have a higher script number. "That, and don't we have 10-20 that take Afrezza here? That's ~10% of the NRx." Are you assuming that every Afrezza user getting a NRx every week? |
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Post by compound26 on Mar 3, 2017 16:41:36 GMT -5
Peppy, its nice to see good investigative thinking but this really again points to management's incompetence (again). And what I see is an incredible amount of effort (including education/promotion) by some shareholders trying to do what management should be doing effectively . It shouldnt be up to the patients or even the doctors to figure this out (and certainly not the shareholders). This is MNKD's responsibility. With a disruptive and revolutionary product you need clear knowledge regarding titration and dosing including step size and timing which all affect retention. How can MNKD spend all this time, effort and funds to educate the endos and still not know what they are doing. Who is going to educate the educator? Forget about the share price and the financial issues ;were talking about the basic properties of the product they cant even instruct on. This should have been figured out a very long time ago. It's appalling. It's no wonder MNKD is where it is. ' But MannKind can't tell the endos anything beyond what the label (currently) says. Why is that so hard to understand? When we get a label change then MannKind can more correctly instruct the docs. Until then the company's hands are tied. Agree. If we get the ultra-fast classification and fewer hypo indication, that would greatly help! My understand is that Mannkind applied for both. |
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Post by compound26 on Mar 3, 2017 14:13:08 GMT -5
Scripts aren't the only thing that can help the share price. We could get positive news of royalties or milestone payments for something going on behind the scenes. Given mnkd's track record it is unlikely but is possible. This is the only reason I can think of for a 5:1 split instead of a 10:1 split. I still have some small hope that management is not incompetent. Per Matt's recent presentations, there are many things that Mannkind is working on. A pediatric trial is expected to start right now. Two additional trials (dosage and titration and time in range) for both type one and type two should start sometime later this year. Progress in international filing, discussions with FDA on label improvement (if any, after they filed their application), EpiPen development, discussion with FDA on direct to consumer advertising, etc. |
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Post by compound26 on Mar 3, 2017 12:38:56 GMT -5
less than 5% of outstanding shares sold dropped the price about 30%. NatesNotes Nate Pile @doubledown202 heh - tell me about it :-) I guess all I can remind you of is that nothing changed overnight that makes the co worth 25% less View Message: stocktwits.com/message/76185675 |
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Post by compound26 on Mar 3, 2017 12:25:41 GMT -5
According this site: shortvolume.com/The short volume is about 66% for today, one of the highest in recent months. |
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Post by compound26 on Mar 3, 2017 11:37:33 GMT -5
It certainly is, peppy. I was a little surprised at the 5 to 1, rather than 10 to 1, but I can see a possible rationale for it. Maybe they thought $5 would be an even brighter red target for shorts. However, the specter of the price being driven below a buck quickly, such that we don't get the 10 days over a buck thing rears its head in my sick mind. That would be the penultimate insult. At $5 THEY would have to short the price down by 80% rather than only 40% to drive it again under $1. With needed additional equity funding on the horizon, a 40% decline in PPS was almost a foregone conclusion. IMHO, 5 for 1 is either criminally stupid or maybe just criminal. Starting to wonder about the BOD. 60% (not 40%) at $2.5. 1.5/2.5=60%. |
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Post by compound26 on Mar 2, 2017 19:13:02 GMT -5
Too bad they threw in that "can't be used when you have a cold" nonsense. But overall still an excellent report. The user is very happy and enthusiastic. Showed the user dosing the Afrezza in a happy environment (dining in a restaurant). Showed a scene where the user is saying that "that's (Afrezza) all I needed" for controlling my diabetes. Also clearly stated in this case Afrezza actually saved money (a lot cheaper) compared with RAAs (30$ copay vs $100 copay)! So for this user, much happier life switching from RAAs to Afrezza. And the reporter also did some research on the cost of Afrezza by pooling information from the various insurers and shared such information to the public. That's also helpful. Anyway, this is a much improved report compared with the first few reports that we saw sponsored by Sanofi (see link below), where we just had someone (looks like a diabetes educator) just stated that there is an inhaled insulin available, but then just went through all the situations where Afrezza can not be prescribed. My overall impression is that this report (other than the mistake they made regarding taking Afrezza when you have a cold) is very pleasant to watch (and I do not mind watching it several times) and watching it leaves me (pretending that I knew nothing of Afrezza before watching this report) the impression that Afrezza is something really good. While the report below is not so pleasant to watch and I probably will not watch it more than one time and after watching it, I do not have much impression of what Afrezza is. |
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Post by compound26 on Mar 2, 2017 11:55:31 GMT -5
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Post by compound26 on Feb 22, 2017 12:30:13 GMT -5
Correct, FDA is currently reviewing the ad MNKD plans on running. I believe, final approval will depend on the new label. I am biting. The new label due August/Sept.
It seems to me the FDA could speed that up.
Any insight?
I think the ads and the label improvement are not tied together, at least not at this moment. If I remember correctly, based on the timeline discussed at the previous conference calls, Mannkind expects to have the ads cleared by FDA sometime in the second quarter 2017 while the label improvement decision is expected to be sometime in the third quarter 2017. If the ads and the label improvement are tied together, since FDA is not expected to make a decision on label improvement until third quarter, then they will not be able to clear the ads until third quarter. I do not think Mannkind wants to wait for the release of ads until third quarter. |
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Post by compound26 on Feb 21, 2017 18:51:23 GMT -5
Isn't that what the time-in-range study is all about? A1c is the standard for measuring the effectiveness of diabetes drugs because none of the existing drugs have shown the capability to manage time-in-range the way Afrezza does. If the time-in-range study is successful, then maybe time-in-range will become the new standard of effectiveness. And, therefore, Afrezza will become the new standard of treatment. I missed that. Trial data from time in range would be a killer argument - both because fluctuations are important but also because it is almost impossible to get a bad HbA1c if you stay in range. Listen to Matt's presentation on Feb. 1 from 7'12'' on this. edge.media-server.com/m/p/wf9e94rm Note that Matt specifically said the Pediatric trial will start in this month (Feb. 2017). Below is what Ray said in last November in the third quarter conference call: We recently conducted an advisory board leading to identify ways to enhance and simplify the initiation of Afrezza in clinical practice. At the ad board they resoundingly felt that Afrezza differentiated pharmacokinetic profile made it an invaluable option for treatment of diabetes. Afrezza clears offers advantage to keep patients within a tight glucose target range, potentially leaning to less hyper and hyperglycaemias episodes. To accomplish this, however, the proper dosing and titration of Afrezza is a paramount importance because this is one of the areas that we have seen where healthcare providers struggle. To address these issues we are planning a 12-week to 16-week time and range dose optimization study in type 1 diabetics using CGM with Dexcom or the new Abbott Libre system. This study will be conducted in three to five of the most well-respected institutions in the country, adding credibility to the data and providing an immediate impact on clinical practice. We expect study start up to begin in the first quarter of 2017 with results sometimes in the fourth quarter. Additionally, we are planning a short pilot study for patients with type 2 diabetes that will allow us to simplify dosing initiation and titration. This will help patients get to the optimal dose quickly and effectively. |
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Post by compound26 on Feb 16, 2017 18:30:02 GMT -5
I wish our sales people are more familiar with the trial data. The weight gain/loss issue is one of the benefits of Afrezza (especially if we are talking about type ones) that we can probably present to the doctors (by referring them to the trial data) and the data is right there. Pages 85 and 89 of the Afrezza FDA briefing documents: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM390864.pdfBody Weight – Study 171 At Week 24, subjects in the Afrezza TI Gen2 group had a weight loss (mean change from
Baseline -0.39 kg), whereas subjects in the insulin aspart group had a weight gain (mean change
from Baseline 0.93 kg; p = 0.0079) with the resulting difference between treatment groups in change from Baseline favoring the Afrezza TI Gen2 group (-1.32 kg; 95% CI -2.33 to -0.31 kg; p = 0.0102). Reviewer’s comment: Analysis of body weight is difficult to interpret in light of the difference in efficacy between Afrezza TI and insulin aspart seen in the trial. Body Weight – Study 175 In the Sponsor’s analysis, from baseline to Week 24, subjects’ mean body weight increased 0.49
kg in the Afrezza TI Gen2 group and decreased 1.13 kg in the placebo group, with a betweengroup difference of 1.62 kg favoring the placebo group, 95% CI: 0.90 - 2.34; p <0.0001). The FDA statistical reviewer’s analysis showed similar results. Reviewer’s comment: This result is not remarkable given that insulin is known to cause
body weight gain. A less effective insulin product would be expected to cause less weight
gain.And anecdotal evidence of Afrezza helps weight control is also right there: www.afrezzajustbreathe.com/weigh-loss-on-afrezza/ |
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Post by compound26 on Feb 16, 2017 15:05:46 GMT -5
The "excitement?" Among shorts? Are only hope is a lot of new scripts on March 3. IMO In the end the short term fluctuations do not matter. If Afrezza sells ultimately, we got a winner, and the PPS will take care of itself (for the longs). If it does not sell, then the shorts got a winner, and the PPS will take care of itself (for the shorts). |
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.. Who is talking about pot.? 
You can access it via one of the following links:
