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Post by Deleted on May 31, 2015 10:10:10 GMT -5
Although the author's conclusion of the abstract is disappointing, I believe it's a very small sideshow, as a few have sated here. I'm hoping that we see some PRs this week from Mannkind and Sanofi highlighting the 2 important events focused on Afrezza, the dinner symposium and product theater presentation. I believe that we could see a small boost in price from these but more importantly put more pressure on shorts as their attack points start fading away. It's not material, they won't press release it |
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Post by Deleted on May 31, 2015 10:10:39 GMT -5
I am hoping that many in the medical community will get better acquainted with Afrezza during the ADA and June will be the month where they just start to "get it" in regards to how well Afrezza works and that it is the closest thing we have to a rainbow farting unicorn! Based on picture of the trajectory I'd call it a $hit or Shart. Picture of what trajectory? |
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Post by harryx1 on May 31, 2015 10:38:36 GMT -5
Although the author's conclusion of the abstract is disappointing, I believe it's a very small sideshow, as a few have sated here. I'm hoping that we see some PRs this week from Mannkind and Sanofi highlighting the 2 important events focused on Afrezza, the dinner symposium and product theater presentation. I believe that we could see a small boost in price from these but more importantly put more pressure on shorts as their attack points start fading away. It's not material, they won't press release it Why does it have to be material to PR it? Here's an example of a PR from EXAS just recently on their product: www.businesswire.com/news/home/20150515006001/en/Data-Supporting-Exact-Sciences’-Stool-DNA-Screening#.VWsqw3D3arU |
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Post by Deleted on May 31, 2015 10:47:06 GMT -5
Because it's MNKD and that's what they do.
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Post by harryx1 on May 31, 2015 11:11:59 GMT -5
Because it's MNKD and that's what they do. Well, I have a rainbow pooping unicorn in my backyard. |
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Post by dudley on May 31, 2015 11:56:32 GMT -5
It seems to me almost impossible that a goodly number of endos are not relatively familiar with Afrezza by now. Dr. Bode alone has many patients and his are the ones who are going above and beyond to get the word out and posting irrefutable CGM evidence of their results. ANY doctor with the slightest degree of interest in their patients cannot possibly ignore these results. I think a lot of people are still in the "sounds too good to be true" camp. But as the script count continues to grow and we get a few thousand patients instead of the few hundred we see right now the stories will be so numerous nobody will be able to ignore them.
It is a statistical certainty with time. The reason for this is that the molecular structure of Afrezza - that being the monomer insulin, such as a healthy pancreas produces - will replicate the same results in ANY human body. ANY patient who tries Afrezza will have the same results - it is a biological certainty. The results are NOT too good to be true. The body deals with insulin in exactly the same way. "All" Afrezza has done is create a formulation that actually mimics a normal endocrine system response. Every other insulin in use fails to do this because they are a hexagonal molecule that the body cannot break down as quickly. This is why they are much slower to begin working and why they stay in the system much longer. There is simply no real competition - this is why Al Mann has been and remains so confident.
So regardless of what happens at the ADA - (I personally believe Afrezza will be a big topic of discussion - at least informally in groups at meals etc. ) Afrezza is destined to be a blockbuster with time.
A REAL game changer would be a scholarly article from the likes of Dr. Bode, who is one of the leading experts in the world on insulin delivery. If he writes a paper documenting the unheard-of results his patients like Sam Finta and his group are posting, and that paper gets posted in an ADA publication - game over.
I'm very comfortable holding my shares as long as it takes - I like statistical certainties.
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Post by ezrasfund on May 31, 2015 12:20:09 GMT -5
I would point out that the primary reason that RAA's like Humalog work more slowly is because they are administered by subcutaneous injection, not because they are hexomers, although that may be a factor. Also, like all meds, Afrezza must be properly dosed to be effective, with the right timing depending on the specific meal and the patient profile. Afrezza may be a breakthrough in diabetes treatment, but it is not a magic bullet.
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Post by kc on May 31, 2015 12:26:35 GMT -5
Dudley, welcome aboard. Great comments. I hope that Sanofi has some great in booth materials for the doctors to pick up and take home. Afrezza is a game changer but it won't happen overnight. Let's just be patient and let the process unfold.
It seems to me almost impossible that a goodly number of endos are not relatively familiar with Afrezza by now. Dr. Bode alone has many patients and his are the ones who are going above and beyond to get the word out and posting irrefutable CGM evidence of their results. ANY doctor with the slightest degree of interest in their patients cannot possibly ignore these results. I think a lot of people are still in the "sounds too good to be true" camp. But as the script count continues to grow and we get a few thousand patients instead of the few hundred we see right now the stories will be so numerous nobody will be able to ignore them. It is a statistical certainty with time. The reason for this is that the molecular structure of Afrezza - that being the monomer insulin, such as a healthy pancreas produces - will replicate the same results in ANY human body. ANY patient who tries Afrezza will have the same results - it is a biological certainty. The results are NOT too good to be true. The body deals with insulin in exactly the same way. "All" Afrezza has done is create a formulation that actually mimics a normal endocrine system response. Every other insulin in use fails to do this because they are a hexagonal molecule that the body cannot break down as quickly. This is why they are much slower to begin working and why they stay in the system much longer. There is simply no real competition - this is why Al Mann has been and remains so confident. So regardless of what happens at the ADA - (I personally believe Afrezza will be a big topic of discussion - at least informally in groups at meals etc. ) Afrezza is destined to be a blockbuster with time. A REAL game changer would be a scholarly article from the likes of Dr. Bode, who is one of the leading experts in the world on insulin delivery. If he writes a paper documenting the unheard-of results his patients like Sam Finta and his group are posting, and that paper gets posted in an ADA publication - game over. I'm very comfortable holding my shares as long as it takes - I like statistical certainties.
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Post by dudley on May 31, 2015 15:23:51 GMT -5
Why then , pray tell, has there never been an injectable insulin that has produced the results we are seeing in the Afrezza community today? Sam Finta has been a Type 1 for many years and NEVER achieved the results he is experiencing today with any subcutaneous insulin. Same is true for many others. When something is introduced to a group of users who are now turning in the best numbers of their lives in a very short period of time - numbers they have never before achieved despite using the best possible treatment available - that very much smells to me like a magic bullet.
And it is not just the A1c results. It is the simplicity - eliminating carb counting to a large extent, we have already seen the doses do not have to be calculated nearly as precisely simply because Afrezza is out of your system so much more quickly. A number of patients are reporting ZERO hypos. Psychologically that is a huge benefit, as is sparing your body the trauma of injections.
Smells very much like a magic bullet to me.
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Post by joeypotsandpans on May 31, 2015 15:42:21 GMT -5
Body 96-LB - Efficacy and Safety of Technosphere Inhaled Insulin: Systematic Review and Meta-analysisView session detail Author Block: GREGORY P. WESTCOTT, ETHAN M. BALK, ANASTASSIOS G. PITTAS, Boston, MA, Providence, RI Introduction: Technosphere inhaled insulin (TI) recently became available for clinical use as a non-invasive alternative to subcutaneous insulin in adult patients with diabetes. The purpose of this systematic review and meta-analysis was to determine the efficacy, safety, and patient acceptability of TI. Methods: . We searched MEDLINE, the Cochrane Clinical Trials Register, and the Food and Drug Administration review documents of TI through January 31, 2015 for randomized control trials that compared TI with placebo, subcutaneous insulin, or oral anti-diabetic drugs ( My question and perhaps someone would like to email Gregory so he doesn't end up embarrassing himself and the other two authors, have you seen this live TI user blog gentlemen?: afrezzauser.com/low-a1c-afrezza-week10/ Perhaps you need to look at these results before you state the following: "hemoglobin A1c improvement from baseline favored subcutaneous insulin over TI" which may put into question your credibility IMO) Two reviewers independently assessed trials for inclusion and extracted data on study characteristics, participant baseline characteristics, efficacy, and safety outcomes. Results: 12 trials met eligibility criteria (n=5,273, mean age range 38-61). Among patients with type 1 or insulin-requiring type 2 diabetes, hemoglobin A1c improvement from baseline favored subcutaneous insulin over TI (net difference 0.16% [95% CI 0.06, 0.25]). TI was associated with less weight gain (net difference -1.6 kg [-2.1, -1.6]) and less risk of hypoglycemia (odds ratio 0.61 [0.35, 0.92]) compared to subcutaneous insulin. There was an increased incidence of mild, transient, dry cough in patients treated with TI (odds ratio 7.82 [6.14, 10.15]) and greater decline in FEV1 (net difference -0.038 liters [-0.049, -0.026]). There was no difference in quality of life or overall patient satisfaction. Many trials were designed for non-inferiority, which may introduce bias, and most of the trials were 24 weeks duration or less, thus limiting assessment of long-term safety. Conclusions: Until long-term safety data are available, TI should be reserved for non-pregnant, non-smoking, adult patients with diabetes, free of pulmonary disease, who are needle-phobic and would otherwise delay initiating or intensifying insulin therapy. For patients who are needle-tolerant, subcutaneous insulin appears to be a better option? Not if you ask these users again please see their results ( afrezzauser.com/low-a1c-afrezza-week10/ ) and they are not necessarily "needle-phobic" but rather more interested in a life changing course of therapy resulting in near or at A1c levels never before achieved on "subcutaneous insulin" Wonder how much someone's credibility is worth? Perhaps emailing Gregory to get his thoughts about Sam's week 10 Afrezza Users " Real Life" results before presenting their panel session/poster. Name: Gregory Westcott, M.D. Title: Clinical Associate Department: Medicine Work Group/Hospital: Tufts Medical Center Email Address: Gregory.Westcott@tufts.edu
Primary Affiliation: School of Medicine (Clinical) |
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Post by Chris-C on May 31, 2015 17:56:10 GMT -5
This may be much ado about nothing, and time will tell.
My question still stands. What motivates a clinical practitioner -internist (perhaps not an endocrinologist) without a scientific track record in diabetes research to do a meta analysis of a new inhaled insulin and to submit it as a lead author at this particular ADA meeting at this particular time? And why does the abstract seem to stand silent on the issue of pharmaco-kinetics and dynamics, since even non medical informed observers (many on this board) know that this is a distinguishing feature of Afrezza and that traditional approaches to measuring efficacy in glycemic control may not be ideal?
This is not new data, it is an analysis of existing data based on criteria set by the investigators; the conclusions are subjective "interpretations" of the collective data. So, if this abstract gets any press at all, it will be quickly debunked. Now, if I were executive management, I'd see the possibility of this being a short shill set up and have a plan for countering it. Any reputable scientific reporter should ask respected authorities before releasing anything. However, we all know that the net is full of paid pseudo journalists who earn their paychecks writing hit pieces dictated by hedge funds. Nonetheless, I'm still hoping the concern expressed here will end up being a Don Quixote exercise in jousting windmills.
GLTAL
Chris C
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Post by mnkdorbust on May 31, 2015 18:40:04 GMT -5
Based on picture of the trajectory I'd call it a $hit or Shart. Picture of what trajectory? davinci's profile pic |
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Post by gomnkd on May 31, 2015 19:16:57 GMT -5
This meta-analysis and others amount to nothing. These docs work in a factory like environment and go with the flow. All they care for are about two things: Compliance and Efficacy (A1c).
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Post by Deleted on May 31, 2015 19:54:03 GMT -5
He's probably a new doc finishing his first paper, it'll probably be talked about more here than at the ADA
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Post by notamnkdmillionaire on May 31, 2015 20:01:45 GMT -5
He's probably a new doc finishing his first paper, it'll probably be talked about more here than at the ADA If we don't agonize over it, who will?  |
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