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Post by lakers on Apr 23, 2017 21:08:16 GMT -5
As for Treprostinil, we are making progress with this pipeline product and I believe we may have already scheduled a pre-IND meeting with the FDA at the end of June. Read more: mnkd.proboards.com/thread/6408/mnkd-state-union?page=19#ixzz4f82b92sCTHale's competitor is UTHR Tyvaso which targets 2 indications using the huge, cumbersome bong shown below. Because of Tyvaso mkt acceptance, THale may have an easier time than Afrezza. www.tyvaso.com/Content/dtc/pdf/TD100_Instructions_for_Use.pdfPhase III trial of Tyvaso for a version of interstitial lung disease which manifest pulmonary hypertension. This is a completely different disease from the pulmonary hypertension treated by ourselves and all of our competitors today. In fact, there is no drugs (11:28) all approved for what's called WHO Group 3 pulmonary hypertension associated with interstitial lung disease. Interstitial lung disease ranges from things like – well, probably one of the most famous is idiopathic pulmonary fibrosis. statistics show that there are 30,000 patients who are dying regularly, mean survival of just a handful of years from Group 3 PAH with no approved medicines. It would be a completely virgin so-called blue water type of opportunity for Tyvaso to move into. And capturing as few as a fourth or a third of those patients would result in revenues at the $1 billion level, not to mention the continued growth of that drug in Group 1 pulmonary hypertension. We’re involved in conversations with the FDA regarding the regulatory pathway for an anaphylaxis indication. We are also assessing the possible indications for possible other indications for epi as well. [That could be for mild asthma at low dosage.] For Treprostinil, we submitted a pre-IND meeting request with the FDA on March 8, and we expect to have the meetings with the FDA sometime in May to further articulate what the Treprostinil program may look like. Read more: mnkd.proboards.com/user/1882/recent?page=3#ixzz4f820oCXmWe are going progress the pipeline. We’ve had to start some of these programs quite a lot because we just enough to cash to do it. We need to be successful before we go too far. But our Epi program has gotten a lot of press given the controversy around epinephrine but we do have an inhaled Epi program that’s not in the clinic yet, but we’ve shown feasibility and formulation and so forth and it’s ready to move there. We did meet with the FDA and map out a clinical strategy, so I think that’s ready to go. We also have programs in Treprostinil and Palonosetron and I could spend a lot of time talking about those. We think they are attracting targets because of the way the regulatory pathway works for those. These are essentially generics at this point. We can reformulate them into an inhaled formulation and give them some vantages. So for example for Treprostinil, this is typically done with a nebulizer today. It’s a very long involved treatment and the treatment doesn’t last terribly long. So introducing something you could do with obviously just a few seconds with Afrezza, we think we have some interesting advantages. At the same time Palonosetron typically only given in the doctor’s office. This is injection today. If we could give a home version by inhalation it has some nice advantages in the chemo-induced nausea and vomiting setting. And we continue to just look at other areas as well. And recently we showed this data. This is from an orally inhaled hormone [PTH], interesting way to get into your system and does exactly as we typically see, which is its rapid peak, since we call a pulsatile delivery which is important in these kind of settings, and then it goes away relatively quickly. So this is exactly what you want to see for a drug like this. www.seekingalpha.com/article/4054768Read more: mnkd.proboards.com/user/1882/recent?page=3#ixzz4f83ltuQj
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Post by lakers on Apr 23, 2017 20:44:31 GMT -5
On April 1st, Mnkd would run out of cash this July. How will Mnkd plan to raise cash without diluting shareholders? As Matt stated on 3/16/17, subsequent to the settlement with Sanofi, our cash balance didn't require an immediate need for funding. We are, obviously, continuing discussions with our current noteholders and other financing opportunities we have been approached with. Matt continues to focus on non-dilutive opportunities, if possible.Deerfield deal followed. Ponder this for a moment. $10M is still due this July. Mnkd hasn't announced how to finance or pay cash for it. In addition, Mnkd needs to extend the runway by 6 additional months to Jan 2018 to see DTC effect and prove commercial viability before big BPs get involve. That's $70 M funding Mnkd needs. Draw your own conclusion. Read more: mnkd.proboards.com/thread/6408/mnkd-state-union?page=19#ixzz4f0r51KZTBased on the dilution of the Deerfield conversion, I guess we can conclude that non-dilutive opportunities are indeed NOT possible. Nice try, dbc. Matt'd better have more than one rabbit. We need $70M by July.
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Post by lakers on Apr 23, 2017 2:10:36 GMT -5
BRINGING PAYERS ON BOARD MannKind’s basic plan for boosting Afrezza sales in the United States is to lower prices enough to get insurers to cover the product on favorable terms and then market it in unconventional ways rather than sending an army of sales representatives to doctors. Sanofi failed to get any major payer to include Afrezza on its standard formulary in 2015, even though the drug became available as a fast-acting prandial insulin for patients with type 1 diabetes (T1D) early in the year. Thus, nearly all would-be users needed to secure prior authorization from their doctors before they could get any coverage for the drug. Both MannKind and outsiders who believe Afrezza can still be a big seller agree that securing widespread coverage is a necessary first step to success. Of course, lowering prices will hurt margins on existing sales, but Pfeffer hopes to offset the damage by launching Afrezza in some of the many foreign markets that will rapidly approve drugs that already have FDA approval. MannKind reports that it is already in talks with potential partners from a number of countries that could approve Afrezza without any additional trials. These partners would use their knowledge of the local market not only to shepherd Afrezza onto pharmacy shelves, but also to market it to doctors and patients. Thanks to the potential for fast approval, such partnerships could begin boosting Afrezza sales just months after they start, said Pfeffer, who noted that any substantial increase in sales volume would mitigate the effect of domestic price cuts on margins by allowing MannKind factories to operate more efficiently, thus reducing unit costs. “Much of Afrezza’s future hinges on what kind of deals MannKind signs with companies in foreign markets,” Keith Markey, PhD, who follows MannKind for Griffin Securities, said in an interview with Evidence-Based Diabetes Management (EBDM). “If MannKind only signs a couple low-dollar deals, then it will struggle to offer Afrezza at competitive prices here and it will struggle to escape its current situation. If MannKind can generate significant near-term revenues from foreign deals, though, it will have a real chance of turning things around. Any real cash flow would ease fears about the company’s financial position and increase its ability to market Afrezza in the US. Significant extra sales would also create the sort of economies of scale that would allow MannKind to price Afrezza competitively and still profit on its US business.” - See more at: www.ajmc.com/journals/evidence-based-diabetes-management/2016/march-2016/mannkind-path-to-afrezza-survival-involves-lower-prices-to-woo-payers#sthash.l4WqUR8z.dpuf
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Post by lakers on Apr 22, 2017 15:45:21 GMT -5
On April 1st, Mnkd would run out of cash this July. How will Mnkd plan to raise cash without diluting shareholders? As Matt stated on 3/16/17, subsequent to the settlement with Sanofi, our cash balance didn't require an immediate need for funding. We are, obviously, continuing discussions with our current noteholders and other financing opportunities we have been approached with. Matt continues to focus on non-dilutive opportunities, if possible. Deerfield deal followed. Ponder this for a moment. $10M is still due this July. Mnkd hasn't announced how to finance or pay cash for it. In addition, Mnkd needs to extend the runway by 6 additional months to Jan 2018 to see DTC effect and prove commercial viability before big BPs get involve. That's $70 M funding Mnkd needs. Draw your own conclusion. Read more: mnkd.proboards.com/thread/6408/mnkd-state-union?page=19#ixzz4f0r51KZT
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Post by lakers on Apr 22, 2017 0:54:15 GMT -5
My understanding is as follows: More TRX = More patients on Afrezza More TRX quantity but less patients = More cost to the patients and more revenue to MNKD Do you think it is good? Logically I think it is not good in long term since patients are paying more. Patients don't need to refill as often while attaining better outcome if additional units are used properly and timely. What's not to like.
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Post by lakers on Apr 22, 2017 0:26:32 GMT -5
On Apr 2, 2017, The TRX last week was 258. It stuck in the 200 range for over 6 mos. What's are the sale impediments? What is the plan to rectify that? Company answered, This week's TRX was slightly down at 256 (-1%), however, our TRx quantities increased 19% from last week (cartridges fulfilled)! We are confident we are on the right track with our new nurse programs (improving education and awareness), better payor coverage and the clinical programs kicking off, we will see these initiatives will make Afrezza known to physicians and patients, who (other than our stockholders) are who we need to engage with. I believe, as well, that our direct to consumer campaigns will address education, awareness, adoption and adherence. Read more: mnkd.proboards.com/thread/6408/mnkd-state-union?page=19#ixzz4ex940zuJI am surprised that many missed this. The answer was there all along.
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Volume too
Apr 21, 2017 13:33:45 GMT -5
via mobile
Post by lakers on Apr 21, 2017 13:33:45 GMT -5
I think Deerfield is dumping their shares Yes. Deerfield indeed. 30M shares presplit.
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Post by lakers on Apr 21, 2017 9:22:41 GMT -5
Short is at it again. Schwab raised borrow interest again.
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Post by lakers on Apr 21, 2017 9:00:56 GMT -5
$10M due in July has not been resolved. Could that be paid by RLS' milestone payment? What milestone payment? The only money MNKD has received from RLS in milestones was the measly $1 million at the end of 2016. RLS has been a non-factor, and there's no indication that it will be any time soon. MNKD will likely dilute shareholders again to pay the debt, since they have no cash to do it and keep the lights on at the same time. Dilution and stock price erosion seems to be the only thing they're good at. If what you said is true, why wouldn't Mnkd announce dilution in one shot but only for $6M? Mnkd must have anticipated at least $10M cash from some entity, RLS or ex-US partner.
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Post by lakers on Apr 21, 2017 8:50:29 GMT -5
$10M due in July has not been resolved. Could that be paid by RLS' milestone payment?
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Post by lakers on Apr 15, 2017 11:31:00 GMT -5
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Post by lakers on Apr 9, 2017 13:16:41 GMT -5
Damon tried A and still stays with it for over 1.5 yrs. He is one satisfied customer.
The famous singer of Chain is also T1. Mnkd being physically close to Hollywood should approach more celebrities.
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Post by lakers on Apr 8, 2017 13:06:55 GMT -5
Afrezza is listed as sponsor instead of the company Mannkind as opposed to Lilly, Novo. Is Afrezza going to be spun off as a separate company? Equal (the sugar substitute) is also listed as a sponsor but I don't think that means that Equal is going to be spun off by Merisant. MannKind has only one diabetes drug which is not the case with Lilly and Novo. The Change of Control 8K filing clearly indicates a long term financial resolution is near. BoD know that they need a long term financial solution for A to succeed commercially and they have been searching for a long time.
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Post by lakers on Apr 8, 2017 12:19:38 GMT -5
we know there are many reasons for an 8K. Here is a quick synopsis. 8k - Material event What is an '8-K' An 8-K is a report of unscheduled material events or corporate changes at a company that could be of importance to the shareholders or the Securities and Exchange Commission (SEC). Also known as a Form 8-K, the report notifies the public of events reported including acquisition, bankruptcy, resignation of directors or a change in the fiscal year. BREAKING DOWN '8-K' As opposed to the annual reporting of Form 10-K and the quarterly reporting of Form 10-Q, public companies utilize Form 8-K as needed. An 8-K is required to announce major events relevant to shareholders. Cheds Breakdown: 8k can be a very powerful catalyst, or can be a big sell signal depending on what it says. This is the legit version of a PR, because an 8k has to be truthful and a CEO can not lie. If there is a reverse merger, you will see in the 8k, if there is a new toxic note taken out, you will see it in an 8k, and if there is a new CFO or CEO, you will see it in an 8k, etc.
Chicago CBS 2 is the official Media partner. Hope they will provide an online video of the 4/8/2017 ADA event with interviews. Afrezza is listed as sponsor instead of the company Mannkind as opposed to Lilly, Novo. Is Afrezza going to be spun off as a separate company? Does it mean TS pipelines will be sold to RLS, Lily, Novo, Mylan, UTHR, CBD investors for at least $0.5B to finance Afrezza ? I prefer this so that we finally untangle from the starving vicious circle to properly commercialize, conduct trials for Afrezza for Ped, titration, time in range, UR labels. I always think Mnkd can't have it both ways and survive. It needs to sell TS pipelines for A to succeed. Mnkd can't nickel and dime, dink and dunk its way out of the perpetual starvation any longer. A needs at least 3 more years to succeed. See Matt's comparative chart. Thus it needs to be sufficiently financed, 0.5B - Notes. Is that why no additional share was proposed at 5/18 ASM in Danbury considering Mnkd has Notes due in a few months and runs out of cash this July? Mnkd said, Understandably, there are many parties who are waiting to see if Afrezza is adopted by the US and will be around. There are also many parties who want to be the first to introduce Afrezza in their regions. While there are ongoing discussions, our corporate policy is not to announce any material developments until there is definitive progress (translated to legally bounded agreements). Once potential international partners realize that A will be around for a foreseeable future, they will jump it with both feet. Success begets more success. Read more: mnkd.proboards.com/thread/7525/castagna-visit?page=2#ixzz4dgKNKNfh
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Post by lakers on Apr 8, 2017 11:23:01 GMT -5
www.diabetes.org/in-my-community/diabetes-expos/chicago/Chicago CBS 2 is the official Media partner. Hope they will provide an online video of the 4/8/2017 ADA event with interviews. Afrezza is listed as sponsor instead of the company Mannkind as opposed to Lilly, Novo. Is Afrezza going to be spun off as a separate company? Does it mean TS pipelines will be sold to RLS, Lily, Novo, Mylan, UTHR, CBD investors for at least $0.5B to finance Afrezza ? I prefer this so that we finally untangle from the starving vicious circle to properly commercialize, conduct trials for Afrezza for Ped, titration, time in range, UR labels. I always think Mnkd can't have it both ways and survive. It needs to sell TS pipelines for A to succeed. Mnkd can't nickel and dime, dink and dunk its way out of the perpetual starvation any longer. A needs at least 3 more years to succeed. See Matt's comparative chart. Thus it needs to be sufficiently financed, 0.5B - Notes. Is that why no additional share was proposed at 5/18 ASM in Danbury considering Mnkd has Notes due in a few months and runs out of cash this July? Mnkd said, Understandably, there are many parties who are waiting to see if Afrezza is adopted by the US and will be around. There are also many parties who want to be the first to introduce Afrezza in their regions. While there are ongoing discussions, our corporate policy is not to announce any material developments until there is definitive progress (translated to legally bounded agreements). Once potential international partners realize that A will be around for a foreseeable future, they will jump it with both feet. Success begets more success. www.diabetes.org/in-my-community/diabetes-expos/chicago/speaker-schedule.htmlMain Stage Schedule 10:15 a.m. to 11:00 a.m. New Perspective on Diabetes Kanika Ghai, MD, Division Director Pediatric Endocrinology Presented by Meridian 11:10 a.m. to 11:40 a.m. Find Your Voice With Mike Golic Former Professional Football Player & Sports Host Presented by Janseen 11:45 a.m. to 12:30 p.m. Taking the Stage to Shine a Light on Diabetes Legendary Entertainer Ben Verreen Presented by Novo Nordisk 12:35 p.m. to 1:20 p.m. Diabetes in Geriatrics Abrar Husain, MD Presented by Jencare 1:25 p.m. to 2:10 p.m. The Ins and Outs of Adding Inhaled Mealtime Insulin to the Type 2 Plan Alan Marcus, MD, FACP, FACE South Orange County Endocrinology Hip Hop, Movie Mogul and Diabetes Advocate Damon Dash Presented by Afrezza 2:15 p.m. to 2:45 p.m. DME Ambassador Stephen T. Presented by Regeneron 2:45 p.m. to 3:15 p.m. The ABCs of Diabetes Farah Hasan MD, FRCP, FACE, FACP, Center for Advanced Care at Orland Park, University of Chicago Medicine Hope the last speaker discuss Afrezza as well.
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