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Post by careful2invest on Dec 20, 2016 10:06:46 GMT -5
finance.yahoo.com/news/novo-nordisk-receives-fda-approval-190000259.html?soc_src=social-sh&soc_trk=twNovo Nordisk Receives FDA Approval of Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL) for Use in Children and Adolescents With Diabetes PR NewswireDecember 19, 2016 PLAINSBORO, N.J., Dec. 19, 2016 /PRNewswire/ -- Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL), a once-daily, long-acting basal insulin, to be used in children and adolescents with diabetes. Tresiba®, first approved by the FDA in September 2015, is now indicated to improve glycemic control in patients with type 1 and type 2 diabetes from the age of one through adulthood,1 making it the only basal insulin approved for both type 1 and type 2 diabetes in patients as young as 1 year old. Tresiba® is a long-acting insulin that is released over time, has a 25 hour half-life and has a consistently flat and stable profile at steady state.1 "We are seeing a rise in the number of children and adolescents with diabetes in the U.S., especially those with type 2, and are proud to support these patients by offering new and effective treatment options," said Todd Hobbs, M.D., U.S. chief medical officer, Novo Nordisk.2 "It can be challenging for children with type 1 diabetes and their parents to manage blood sugar levels and keep up with multiple injections throughout an already busy day. With this approval, they now have another option of a long-acting insulin that is dosed once daily." Novo Nordisk submitted the supplemental New Drug Application (sNDA) based on the results of the BEGIN™ Young 1 trial, a multi-national, 26-week, phase 3b, randomized, controlled, open-label, parallel-group, treat-to-target non-inferiority trial with a 26-week extension. BEGIN™ Young 1 compared the efficacy and safety of Tresiba® administered once-daily compared with Levemir® (insulin detemir [rDNA origin] injection) administered once-daily or twice daily, both in combination with insulin aspart, a mealtime insulin, in children and adolescents with type 1 diabetes aged 1 to 17. The results showed that Tresiba® in combination with insulin aspart effectively improved glycemic control. The most common adverse events were infection, hypoglycemia and hyperglycemia.3 The use of Tresiba® in patients one year of age and older with type 2 diabetes mellitus is also supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes.1 Since it is pretty clear that Tresiba, used in coffnjnction with AFREZZA gives a Diabetic non diabetic A1C readings, all day long. Is Novo supportive of the pairing of these two? And secondly, are they doing anything to inform the FDA of these findings? GLTA TRUE LONGS! BTW, it looks like today might just be another good day, already over .86 cents with heavy volume!!! I'm liking this!
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Post by careful2invest on Dec 20, 2016 2:54:30 GMT -5
Can anyone explain the pop? I can't find any news or upgrades. Thanks in advance! Well, it could be A) The rebalance of shares B) Zacks recent upgrade C) The collaboration between MNKD and the JDRF D) Shorts feeling the squeeze of a shift in momentum E) Knowing that we are one day closer to a label change F) Knowing that we are one day closer to a RLS milestone payment G) Interim agreement between MNKD and the VA, (Check the thread below this one) OR...H) It could just be that people are finally realizing that AFREZZA simply works better than anything else known to man! (second only to a healthy human pancreas) OR...
I) A combination of all of the above! Tomorrow should be telling. If the trend continues...We might finally be on our way to something "epic" GLTA TRUE LONGS!
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Post by careful2invest on Dec 20, 2016 0:59:12 GMT -5
Thank you for following up. I really appreciate it. Google working with Vdex is great news. Of course that now raises a zillion other questions and possibilities including how the Google/Ondou/Sanofi relationship fits into this. I haven't heard anything about Google and Vdex?
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Post by careful2invest on Dec 18, 2016 22:26:06 GMT -5
Sports, I was going to ask this question in my response to Mike M, (because it may tie in with the containment of script counts that he is claiming) but was not sure that you would see it. Did MNKD ever meet with the group of docs that were interested in Afrezza that you had met and kind of orchestrated? I think from Arizona? Thanks I'm not sure what you mean, AZ? You don't mean Rancho Medical where I work right? ( Good News thread ). Yes, That's what it was. The "some good news thread." I just went back and read it. I don't know how I missed that one! For those that may not know, The meeting did take place Oct 10 and was indeed a success!! Thank you Sports for clarification and for orchestrating that entire meeting!
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Post by careful2invest on Dec 18, 2016 19:10:47 GMT -5
Bringing Yahoo message boards over here awesome. I don't know how many more times it needs to be reiterated that SNY is completely out of the picture, there is nothing going on behind the scenes like Yahoo message boards spewed for years. @kbrion, Others on this board disagreed with the OP, but did so in a civil manner. That's what distinguishes us from the "other" board. That, and so much else makes this board different from the "other" board, Liane. Night and day! Keep up the good work!
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Post by careful2invest on Dec 18, 2016 19:03:47 GMT -5
OH....sorry for having an opinion and contaminating your board. Good to see you Mike:-) Sports, I was going to ask this question in my response to Mike M, (because it may tie in with the containment of script counts that he is claiming) but was not sure that you would see it. Did MNKD ever meet with the group of docs that were interested in Afrezza that you had met and kind of orchestrated? I think from Arizona? Thanks
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Post by careful2invest on Dec 18, 2016 18:57:19 GMT -5
MNKD has kept Afrezza alive but subdued...."on hold" if you will, waiting for all the elements of the end game to be finalized. This sure has disallowed the short raids and empowered those who truly believe in MNKD to acquire on the cheap. I continue to believe that SNY and Google (in their partnership) has Afrezza in their pocket. SNY is going to take a major hit with Lantus generics in 2017 and they have no real winners in their product funnel unlike MNKD. I believe that SNY is supporting MNKD with their "settlement" until all the elements are fully in place which have been plentiful and very challenging. Ever wonder why the new scripts are constantly at the same disappointing level and why no advertising is taking place to get this off dead center? Ever think they might want the pps where it is (stalled) until they make their announcements. Why isn't MNKD concerned about delisting and for that matter....where is their shareholder concern? Do you really believe that all the tech platforms of MNKD are not recognized and their value fully understood by big pharma; do you think they are all brain dead? This has been a very long, trying, exasperating journey but if you continue to perform DD and put the pieces together you can see the end picture. MNKD will indeed have an EPIC story which I thought would have materialized by now but 2017 will be the year. Mike, first off, Welcome, I wondered where you went... Secondly, How's it feel to be called a "newbie" when you bought MNKD at the IPO? (Just bustin your chops.) And now to my point... I, like most, have been watching the script count remain low and unfortunately rather consistent. Very reminisent of when Sanofi was in control (sales) and we investors came up with reasons (excuses) then and many are doing it again. Hindsight tell us that there was clearly something else really going on back then, and I, too, have often wondered if that is the case now. I just mentioned in a recent post that the forward thinkers of Google have got to be well aware of the potential of AFREZZA/TECHNOSPHERE. It would make no sense for GOOGLE to ignore it. Sanofi' current involvement, on the other hand, I do not feel that I have seen anything convincing enough to comment. Unless their still in an agreement with Google. And then your theory can be more likely to come to a reality. I feel that we are on the cusp of some major positive events! Although I have felt like this more than once or twice over the last 7 years! Whether it happens this week, or next year, I will be here! GLTA TRUE LONGS!
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Post by careful2invest on Dec 17, 2016 15:19:16 GMT -5
Sure. Shoot the dream down. Central, when the script numbers finally begin a steady climb upwards and show traction....I think waking up to that kind of pre-market action will be a real possibility! JMHO I agree Slugworth. Those numbers are more than attainable, and even longer term, it can get even better! Example... I have mentioned Pharmacylics (PCYC) before. PCYC had one drug treatment for Leukemia. One! Advibb outbid J&J for the one drug and the stock went from trading at around .80 cents/share to over $260.00/share The potential is there! GLTA TRUE LONGS!
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Post by careful2invest on Dec 17, 2016 0:47:00 GMT -5
Anyone besides me thinking 2017 will be tougher for mannkind than 2016 even was? IMHO, 2017 should be much, much better than 2016. At least I hope!! A lot of the heavy lifting has been done and many components are in place that will help MNKD/AFREZZA/TECHNOSPHERE become a success! GLTA TRUE LONGS!
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Post by careful2invest on Dec 16, 2016 18:22:42 GMT -5
Just my speculation but did you see the level of scripts last Fall and Winter ahead of Sanofi canceling contract? Sanofi punted on Afrezza and focused their reps on their other drugs. So, what do you think the endo or primary care physician that heard of Afrezza's effectiveness, uniqueness and wonderful pk/pd profile in, say, May and June of last year, was hearing about Afrezza in October of last year? At best for Mannkind and Afrezza they said NOTHING. (even though saying NOTHING is sort of negative in itself as it would leave the endo or pcp wondering "what's going on with Afrezza, why the silence". At worst, the rep had to say SOMETHING in regards to Afrezza. What do you think he/she said in October/November? It most likely wasn't flattering. It most likely had to address the fact that people were having trouble titrating, getting use to. It most likely had to be conversational between the rep and endo about initial users experiences with taking Spirometry test (hurdles) , troubles getting insurance, problems with formularies. So, in general, that is all sort of negative, or at least not positive, and not particularly shining a "everything is bright and wonderful" with Afrezza. So....that's kind of what I meant about some past Sanofi Afrezza sales person may not be the greatest to hire and promote. He/she was the same person that had to talk his/her way OUT of Afrezza last fall and share that tale to the endo and pcp. Is that who Mannkind wants to represent the product going forward? Move onto to others who don't have the baggage, negative past history and what that conotes. I will say this...some said nothing! If the doctor didn't ask about afrezza the rep would say NOTHING! True story! Crazy stuff! Sax, While I am not questioning your credibility, I am wondering what or who was your source for this piece of information. It seems to me that this point would be nearly impossible to prove, or disprove given the number of individual conversations that were had during the period that Sanofi was in control of marketing AFREZZA.
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Post by careful2invest on Dec 16, 2016 17:15:45 GMT -5
The other concern is that this was the team of reps that basically ditched Afrezza and left it to die on the vine. Now, they would have been directed from the top but they took marching orders to cease selling it. What did these Sanofi reps tell the Docs at that point after trying initially? So, does Mannkind hire the same people who probably dismissed, denigrated, trash talked and/or downplayed Afrezza's effetiveness a year ago just because they are unemployed? "So, does Mannkind hire the same people who probably dismissed, denigrated, trash talked and/or downplayed Afrezza's effetiveness ...". Your documentation that this occurred? (Perhaps there were one-offs, but the entire sales force?) Imho, there are enough quality sales people out there in the pool of potential new hires, that if the resume shows Sanofi as previous employer, go to the next candidate! The sandbagging point can be argued back an forth forever, basically does not matter at this point. But for the record, I think that it is more than clear that Sanofi sandbagged AFREZZA and hurt the brand. However, I do believe that we will overcome that major setback. GLTA TRUE LONGS!
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Post by careful2invest on Dec 13, 2016 14:08:40 GMT -5
It is definitely time that MNKD communicates with their investors. Last we heard from Matt, he said that he was not concerned with the issue of being delisted from Nasdaq. Maybe that is true and he has a plan that makes any type of delisting a non issue. BUT, here we are again, in the dark! I realize that delisting does not translate into inevitable doom, and you can sugar coat it however you choose to, But it is still NOT GOOD news! Matt, Mike, its time!! Give us something...
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Post by careful2invest on Dec 12, 2016 20:27:58 GMT -5
If it was said, it got by me as well! What I do remember hearing was that a large Pharma company (their name escapes me at this time, the seventies were rough) was laying off a large number of their employees at the same time MNKD needed sales people and Mike C felt fortunate to be able to have this large amount of skilled people newly available in which to choose from. That is how I remember it. AstraZeneca reps. Thank you Sports! Maybe I should have "just said no" back then!
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Post by careful2invest on Dec 12, 2016 17:29:10 GMT -5
2 hours ago. 11ALIVE-TV in Atlanta. That specific WFAA report has made its way to more then just 3 stations now. It's syndicated across TEGNA which has quite a few stations across the country. More positive news!! I'm loving it! GLTA TRUE LONGS!
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Post by careful2invest on Dec 12, 2016 17:25:38 GMT -5
We now have a lot of people who know what really went on behind the scenes and have nothing to lose by talking. Its been settled what does it matter at this point As far as the general public as well as many Diabetics, Endo's and GP's know, AFREZZA was a failure ( according to Sanofi)Exposing what really went on (with Sanofi's handling of AFREZZA) would certainly help shed that false image of AFREZZA not being worthy of being marketed in the US, as Sanofi stated when they ended their partnership with MNKD. AFREZZA would be so much further ahead had an honest effort from a large BP taken place two years ago. Instead of a near burial! There is no doubt that stigma is still hurting the marketability and general acceptance of AFREZZA. To what degree is subjective. Can MNKD overcome this? I believe so. The more people that get exposed to AFREZZA, the closer we get to success! JDRF being involved as well as other components that have been put in place are all positive. We are finally heading in the right direction! Better late than never! GLTA TRUE LONGS!
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