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Post by Deleted on Dec 24, 2015 16:02:36 GMT -5
Lakers, did you know potential to announce was even prior to 1q 16? Interesting on your calls, I don't care to now how/why.
Yes. Had the co not announced before 12/24, it will not have announced on 12/28-12/31 but 1/4/16. The holiday heavy window necessitates mgmt to either announce on 12/23 or 1/4/16 before DeSisto joins 1/5. That's why I later said the news was very close, imminent. Glad you saw that, very perceptive ! Water under bridge, What's next is more interesting. are they closed for the holidays until new year? |
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Post by EveningOfTheDay on Dec 24, 2015 17:53:40 GMT -5
OK fine, I am not a Kliff fan either, actually much the contrary. However, the point is not what he says, but if what he says is true or not. In the past I have always thought Kliff's posts were very disingenuous, but is what he is saying about DeSisto correct? If it is not, Kliff could be leaving himself exposed to a lawsuit for defamation.
We all have been quick in judgement when it comes to what MNKD is doing, thinking the science is so sound it should be a no brainer to get Afrezza to diabetics, but we all have been proven wrong time and again. We need more time, but we need to be cautious too, even if optimistically cautious. All this IMHO, of course.
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Post by mssciguy on Dec 24, 2015 18:26:42 GMT -5
OK fine, I am not a Kliff fan either, actually much the contrary. However, the point is not what he says, but if what he says is true or not. In the past I have always thought Kliff's posts were very disingenuous, but it what he is saying about DeSisto correct. If it is not, Kliff could be leaving himself exposed to a lawsuit for defamation. We all have been quick in judgement when it comes to what MNKD is doing, thinking the science is so sound it should be a no brainer to get Afrezza to diabetics, but we all have been proven wrong time and again. We need more time, but we need to be cautious too, even if optimistically cautious. All this IMHO, of course. Kliff and Feuerstein are not journalists. They are professional assassins. Dregs of the publishing world. That said, why MNKD hasn't had some kind of public relations point man is beyond belief. |
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Post by purge on Dec 24, 2015 18:46:45 GMT -5
Mark Twain said it best. "If you don't read the newspaper, you're uninformed. If you read the news paper, you are mis-informed."
Today this is more true than ever. The media doesn't try to inform you. It tries to brainwash you.
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Post by EveningOfTheDay on Dec 24, 2015 19:25:51 GMT -5
Kliff and Feuerstein are not journalists. They are professional assassins. Dregs of the publishing world. I am not arguing this at all. Kliff's writing, all of it, feels like hit job for the well stablished major diabetes companies. However, is what he is saying true? Was DeSisto fired from his previous position? Did he leave a mess the current CEO is still cleaning up? These are pretty strong accusations, don't you think? They are also very relevant to us. |
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Post by mssciguy on Dec 24, 2015 19:39:09 GMT -5
Kliff and Feuerstein are not journalists. They are professional assassins. Dregs of the publishing world. I am not arguing this at all. Kliff's writing, all of it, feels like hit job for the well stablished major diabetes companies. However, is what he is saying true? Was DeSisto fired from his previous position? Did he leave a mess the current CEO is still cleaning up? These are pretty strong accusations, don't you think? They are also very relevant to us. I agree completely but my hands are sore from so much hand wringing. From everything that I can see, it's Wall Street that manipulating here. I have spent way too much time this year monitoring boards besides this one, and the complaints about orders not filling, as well as the obvious dark pool activity (controlled price throughout the day with a huge jump in volume in the last few minutes), the naked shorting, it's sabotage and the so-called journalists like Kliff and AF probably hang out at the same bars as the hedgies. Very incestuous, heck, you can even go back and look at AF and Shrkeli tweeting to each other. Totally mistrustful of Wall Street here. Completely. Especially for a small cap stock like this with no apparent defenses. I've been hit hard before and will recover regardless of whether or not the new CEO delivers on protecting shareholder value--- the big question for little people like us may be whether or not single stocks are safe at all for the retail crowd. It's currently open season on retail investors on Wall Street, and for safety, ETFs or non-participation may be the best options. It's been a real education. I'll take my lumps, if necessary, and concentrate on my own small business. My customers are happy and there is no GSCO to steal my lunch money daily! Mele Kalikamaka |
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Post by lakers on Dec 25, 2015 14:59:08 GMT -5
Real news on next 2 in the pipeline or EU approval? Sanofi hasn't filed EMA, ME MAA's yet. But that may change next year. Sanofi is obligated to inform Mnkd immediately after they file. I agree that superiority clinical study duration is about 7 mos after recruiting ends, long enough to measure A1C at least once or twice, hypo events, weight loss, cardio events, lung capacity at least once after 6 mos, time in range, 46 participants. The big Q is will Sanofi wait till the superiority trial finishes to file MAA or file it first, then apply for label change just before final approval b/c the longest pole will be 210 days max coinciding w/ 7-mo superiority trial. Regardless, all analysts covering Mnkd agreed that MAA would be a catalyst for pps. Next partnership will be pain, migraine mgmt, ready for human clinical trials. A Superiority Trial Case Study, 6 mos, 404 PWDs. Novo Nordisk's Victoza beats Sanofi's lixisenatide in type 2 diabetes study - NVO | Seeking Alpha [Sny should have fought back by comparing Afrezza to Novolog, Humalog, and developed inhaled GLP-1] Sep. 16, 2015 10:42 AM • SA Editor Douglas W. House Results from a Phase 4 study, called LIRA-LIXI, comparing Novo Nordisk's (NVO -0.1%) Victoza (liraglutide) to lixisenatide (Sanofi (SNY +1.4%)), both in combination with metformin, showed treatment with liraglutide lowered HBA1c -1.83% versus -1.21% (p<0.0001) significantly greater in patients with type 2 diabetes. The results were presented today at the 51st Annual Meeting of the European Association for the Study of Diabetes in Stockholm, Sweden. Data from the 26-week 404-subject trial also showed that liraglutide produced significantly greater reductions in fasting plasma glucose (p<0.0001) and mean nine-point self-measured plasma glucose (p<0.0001) compared to lixisenatide while producing greater postprandial increments for the meal following injection (p<0.0001). The safety profile was similar between the two groups. Victoza was administered once daily at any time irrespective of meals while lixisenatide was administered once-daily within an hour prior to the morning or evening meal. Victoza, a GLP-1 analog, was launched in the EU in 2009. A recombinant version was approved by the FDA under the brand name Saxenda in December 2014. Sanofi intends to file its NDA (brand name LixiLan) with the FDA in Q4 and its MAA in the EU in Q1 2016. Read more: mnkd.proboards.com/thread/4224/snys-inhaled-lyxumia-glp-ra#ixzz3vMe2mi7F |
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Post by Deleted on Dec 25, 2015 15:15:04 GMT -5
Sanofi hasn't filed EMA, ME MAA's yet. But that may change next year. Sanofi is obligated to inform Mnkd immediately after they file. I agree that superiority clinical study duration is about 7 mos after recruiting ends, long enough to measure A1C at least once or twice, hypo events, weight loss, cardio events, lung capacity at least once after 6 mos, time in range, 46 participants. The big Q is will Sanofi wait till the superiority trial finishes to file MAA or file it first, then apply for label change just before final approval b/c the longest pole will be 210 days max coinciding w/ 7-mo superiority trial. Regardless, all analysts covering Mnkd agreed that MAA would be a catalyst for pps. Next partnership will be pain, migraine mgmt, ready for human clinical trials. A Superiority Trial Case Study, 6 mos, 404 PWDs. Novo Nordisk's Victoza beats Sanofi's lixisenatide in type 2 diabetes study - NVO | Seeking Alpha [Sny should have fought back by comparing Afrezza to Novolog, Humalog, and developed inhaled GLP-1] Sep. 16, 2015 10:42 AM • SA Editor Douglas W. House Results from a Phase 4 study, called LIRA-LIXI, comparing Novo Nordisk's (NVO -0.1%) Victoza (liraglutide) to lixisenatide (Sanofi (SNY +1.4%)), both in combination with metformin, showed treatment with liraglutide lowered HBA1c -1.83% versus -1.21% (p<0.0001) significantly greater in patients with type 2 diabetes. The results were presented today at the 51st Annual Meeting of the European Association for the Study of Diabetes in Stockholm, Sweden. Data from the 26-week 404-subject trial also showed that liraglutide produced significantly greater reductions in fasting plasma glucose (p<0.0001) and mean nine-point self-measured plasma glucose (p<0.0001) compared to lixisenatide while producing greater postprandial increments for the meal following injection (p<0.0001). The safety profile was similar between the two groups. Victoza was administered once daily at any time irrespective of meals while lixisenatide was administered once-daily within an hour prior to the morning or evening meal. Victoza, a GLP-1 analog, was launched in the EU in 2009. A recombinant version was approved by the FDA under the brand name Saxenda in December 2014. Sanofi intends to file its NDA (brand name LixiLan) with the FDA in Q4 and its MAA in the EU in Q1 2016. Read more: mnkd.proboards.com/thread/4224/snys-inhaled-lyxumia-glp-ra#ixzz3vMe2mi7Fso if 6 to 9 months is sufficient for proving superiority with 400 pwd's ... this should have been done by now.. unfortunately with Mannkind its always late |
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Post by pktrump on Dec 25, 2015 15:25:02 GMT -5
I would like to see MNKD start a long term study on pre diabetics to assess whether AFZ can stop the progression of disease.  |
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Post by lakers on Dec 25, 2015 15:32:14 GMT -5
I would like to see MNKD start a long term study on pre diabetics to assess whether AFZ can stop the progression of disease. First thing first, higher priority is given to label improvement which helps place Afrezza in Tier 2 and justify premium price in U.S. EU pricing follows precedence in U.S. ME pricing follows precedence in EU and U.S. Superiority Trial should start 1Q16 if not Jan. I agree w/ the criticism that it should have been started 6 mos ago. Requirement/Commitment Number 2 Required Under FDAAA Section 505(o)(3) Original Projected Completion Date 03/31/2017 Description Conduct a dose-ranging PK-PD euglycemic glucose-clamp trial to characterize the dose-response of Afrezza relative to subcutaneous insulin in patients with type 1 diabetes. Select at least three to four doses for each route of insulin administration to ensure both the linear and curvilinear portions of the dose-response curves are adequately captured and characterized. Compare the dose-response curves for Afrezza and subcutaneous insulin noting the dose at which the response becomes curvilinear for each. These data may impact labeling recommendations for dosing and thereby mitigate the risk of diabetic ketoacidosis, which has been observed with Afrezza. Current Status Ongoing Requirement/Commitment Number 3 Required Under FDAAA Section 505(o)(3) Original Projected Completion Date 01/31/2017 Description A PK-PD eugylcemic glucose-clamp trial to characterize within-subject variability for Afrezza pharmacokinetic (PK) and pharmacodynamic (PD) parameters. These data may impact labeling recommendations for glucose monitoring and thereby mitigate the risk of hypoglycemia, which has been observed with Afrezza. |
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Post by EveningOfTheDay on Dec 25, 2015 15:36:45 GMT -5
First thing first, higher priority is given to label improvement which helps place Afrezza in Tier 2. And I will be static when I see some actual prove that Sanofi is pushing for this. Logic would dictate that they are working on it or should be working on it, but corroboration, other than speculations about the San Diego meeting, would be a nice thing to have. |
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Post by lakers on Dec 25, 2015 15:39:22 GMT -5
First thing first, higher priority is given to label improvement which helps place Afrezza in Tier 2. And I will be static when I see some actual prove that Sanofi is pushing for this. Logic would dictate that they are working on it or should be working on it, but corroboration, other than speculations about the San Diego meeting, would be a nice thing to have. Label improvement initiative has been publicly disclosed in a slide. Please search and post. I am certain you can find it. |
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Post by Deleted on Dec 25, 2015 15:41:05 GMT -5
I would like to see MNKD start a long term study on pre diabetics to assess whether AFZ can stop the progression of disease. First thing first, higher priority is given to label improvement which helps place Afrezza in Tier 2 and justify premium price in U.S. EU pricing follows precedence in U.S. ME pricing follows precedence in EU and U.S. Superiority Trial should start 1Q16 if not Jan.
Is the trial registered with fda yet or the meeting findings in San Diego being drafted? |
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Post by lakers on Dec 25, 2015 15:44:02 GMT -5
First thing first, higher priority is given to label improvement which helps place Afrezza in Tier 2 and justify premium price in U.S. EU pricing follows precedence in U.S. ME pricing follows precedence in EU and U.S. Superiority Trial should start 1Q16 if not Jan.
Is the trial registered with fda yet or the meeting findings in San Diego being drafted? Sanofi is in charge of superiority study which has not been registered w/ FDA yet. |
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Post by EveningOfTheDay on Dec 25, 2015 15:52:53 GMT -5
And I will be static when I see some actual prove that Sanofi is pushing for this. Logic would dictate that they are working on it or should be working on it, but corroboration, other than speculations about the San Diego meeting, would be a nice thing to have. Label improvement initiative has been publicly disclosed in a slide. Please search and post. I am certain you can find it. A slide, you say. Yes, I have seen the slide.  So your point posting all this peripheral stuff that does not touch Mannkind directly is what? To prove that Sanofi is working on the background in several things and that eventually they will get to MNKD? Again, I am not doubting your sources, they seem to be better than mine, just curious. As I said logic would dictate Sanofi is working on several aspects of Afrezza, but if they are neither them or Mannkind is giving us any indication of it, other than slides, which from time to time I too have used as a reference. |
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