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Post by rtmd on Jun 15, 2019 21:45:13 GMT -5
It seems to me that if this were a viable plan, some big pharma would have already pursued it. I mean, why isn't Lilly bypassing distributors and pharmacies by selling humalog directly to consumers via specialty diabetes clinic? It would put that much more money in their pockets plus give them additional cash flow from whatever other services the clinics could offer.As I pointed out in a previous post, many states don't allow clinics or other medical practices to sell prescription drugs directly to consumers -- or only allow them to dispense a few days supply until their patients can get their prescriptions filled at a pharmacy. The closest that drug companies are getting to selling drugs directly to patients is by making arrangements with online pharmacies -- arrangements like the one MannKind has with Eagle or Pfizer has with CVS to sell Viagra online. Exactly, my point being that there has to be obstacles -- legal or otherwise -- that have kept drug manufacturers from selling directly to consumers otherwise all the drug manufacturers would likely do so. What makes VDEX think they can do any different?
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Post by mnholdem on Jun 15, 2019 21:46:05 GMT -5
Great post, good points. Just saying...Vdex has their funding now, they are ready to roll:-) but they need to have some protection that they won’t get copycatted. Sports, you keep saying they have funding. They never said they had funding, not even in their proposal. There is no way mnkd can take the proposal seriously without this. I certainly take it seriously. Financial backers may believe that VDex has a sound business plan but are less confident about MannKind’s strategy. They would want their investment protected in the event that MannKind decided Afrezza is not marketable and pull it from the marketplace to divert company resources to other drugs. Disclosure of VDex investors would be disclosed to MannKind during negotiations as each party to the Agreement conducts due diligence to ensure VDex has secured sufficient funds for expansion. The proposal presented to shareholders by VDex is a broad overview of their business proposal to MannKind. Any legal Agreement would be much more detailed and confidential until signed and filed with the SEC, very likely with redacted portions related to purchase price and other remunerations agreed to by both parties.
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Post by sportsrancho on Jun 15, 2019 21:57:02 GMT -5
Agree.....Thanks mnholdem, my brain just does not work at the high-level of capacity that yours does, so I appreciate the explanation👍🏻
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Post by sweedee79 on Jun 15, 2019 22:05:53 GMT -5
The organization backing Vdex probably wants some loose ends tied up before so much money is put at risk.. that is just smart business..
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Post by letitride on Jun 15, 2019 23:40:35 GMT -5
If I was on the BOD I would start with throw down a Bill to let me know you got what it takes to back up all that crap you just put out there.
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Post by winner on Jun 16, 2019 5:46:16 GMT -5
mnholdem. As always thank-you so much for your post(s). If you and Harry were on the Board of Directors, I am of the opinion that there would be many more individuals making use of Afrezza. In closing, I think MannKind should ask Vdex for specifics and if they are sound, give them the opportunity to grow their company. No cost to MannKind and an opportunity to increase sales. WIN - WIN
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Post by mango on Jun 16, 2019 8:14:17 GMT -5
Yesterday, after having taken my grandchildren fishing and tucked them into bed at my cabin in north-central Minnesota, I read the two VDex documents via the links posted on ProBoards-MNKD. The VDex proposal offers MannKind a unique and, perhaps, rare opportunity. For many years MannKind has struggled to position Afrezza in the diabetes community and emerge as a modern breakthrough while being handcuffed to a label that denotes Afrezza as non-inferior to widely adopted RAA insulin. Recent clinical studies have involved small groups of participants rather than gathering trial data from hundreds. The results from recent "pilot" studies seem intended to sway the medical community but have been insufficiently large enough in size and scope to carry the kind of weight that could lead to label changes by the FDA. These small studies have merited only a glance from the ADA and AACE. As a long time shareholder, I have offered several well-intended suggestions to Matthew Pfeffer, Hakan Edstrom and Micheal Castagna throughout the years and have been treated respectfully by these MannKind executives. Before he passed away, I had initiated a discussion with founder Alfred Mann about funding another Mann company. Today I offer a suggestion to MannKind's Board of Directors, CEO, CFO and CMO. MannKind could serious consider offering VDex a counter proposal whereby VDex would be granted limited exclusivity in exchange for providing clinicians and participants for clinical trial data at minimal or no cost to MannKind. A large-scale expansion (for which I suspect that VDex has secured financial backers) would enable clinical and real-world data to be presented to the FDA (for improved labeling) and the ADA/AACE (for updating treatment protocols in the Diabetes Standard of Care). Protocols would be enacted to ensure unbiased and scientifically sound database(s). MannKind would bear the costs of assimilation of clinical data and reporting. I’m not suggesting disclosure or validation of proprietary VDex protocols but other studies and trials designed to improve Afrezza’s position among diabetes treatments. MannKind doesn't appear to have financial resources nor partners/backers to fund large-scale clinical studies with the potential of positioning Afrezza as a major breakthrough in modern treatment of Type 1 and early Type 2 diabetes and large scale clinical trials are horrendously expensive and carry a significant financial risk/reward ratio. I strongly urge the MannKind Board of Directors, Scientific Advisory Board and executive team to begin discussions with VDex. I've calculated that current fallout rate for patients introduced to Afrezza has been in the range of ~60%-80% drop out. Prior and current strategies being executed by MannKind management have resulted in roughly 3-4 negative patient experiences for every successful adoption of Afrezza. That, my friends, is a recipe for failure. If VDex has a less than 20% dropout rate - which the Board could easily verify - than this treatment provider should be taken seriously. As both a long term shareholder and business executive, I urge MannKind to consider the merits of this suggestion and consider scheduling exploratory discussions with VDex rather than snubbing a company that has been developing Afrezza faster and more effectively than any other. The opportunity exists for MannKind and VDex to develop a win-win strategy together to position Afrezza to become the blockbuster envisioned by founder Alfred Mann. Good fortune to all. Nice post. The Real-Life data approach is something i've always wanted MannKind do–via Vdex. I'm of course fully supportive of Vdex so this is a great idea, IMO.
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Post by kimi on Jun 16, 2019 11:45:10 GMT -5
Two notes.
I It seems to me that mannkind (like an air-filled ball) is being submerged by a foreign power (37 million shorts).
What can happen now:
1. Mankind drowns sooner or later
2. Mankind slowly releases pressure and gradually reaches the water surface (milestone payments (RLC-UTHR), Brazil, India, rising scripts etc.)
3. The foreign power is forced to give up immediatley, the ball shoots with full energy vertically out of the water (partnership for Technosphere with high upfront payment)
II • Vdex has 300 Afrezza patients in 5 (?) Clinics. • So 60 per clinic. • Assuming that a script has to be renewed every 6 weeks we are currently working on a weekly script volume of 50 (completely insignificant).
VDEX proposal:
• In 20 countries, with only one clinic each with 60 patients, we get 1200 patients and 200 weekly scripts! • Vdex has almost no influence but makes demands?
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Post by mnholdem on Jun 16, 2019 12:57:14 GMT -5
I believe that the VDex proposal involves only the U.S. market. There’s nothing in the proposal that hinders MannKind’s international agenda. My question is simply this: How can shareholders expect robust sales in foreign countries when management is failing in the U.S.? Big Pharma is just as influential at blocking newcomers outside the U.S. and even more in certain countries.
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Post by veritasfiliatemporis on Jun 16, 2019 13:04:56 GMT -5
Touting VDEX's 20% drop out rate is crazy ... they only have 300 patients. Every doc that I've been to will prescribe something and I follow the directions and use it. If it doesn't work, we look for another answer. But, I don't leave the doc because it failed. So, VDEX's 20% rate for dropouts ... actually makes them a loser. July 1st is the start of progress ... pay off Deerfield ... more progress with UTHR ... maybe I buy more shares? Ha! But, that's mytakeonit I believe somebody here is focusing too much on Afrezza And that's my takeonit
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Post by lennymnkd on Jun 16, 2019 13:20:23 GMT -5
Veritas/ cant help too BIG part of the picture!
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Post by mnkdfann on Jun 16, 2019 13:31:03 GMT -5
I believe that the VDex proposal involves only the U.S. market. There’s nothing in the proposal that hinders MannKind’s international agenda. My question is simply this: How can shareholders expect robust sales in foreign countries when management is failing in the U.S.? Big Pharma is just as influential at blocking newcomers outside the U.S. and even more in certain countries. There are two proposals, one titled to Shareholders and the other to the Board of Directors. They are not the same. The one to Shareholders appears in response to Mannkind's failure to address the one made to its Board. I just mention that because when you say proposal, I don't know which document you are talking about. The proposals are not the same, and discuss different issues. Anyway, the proposal to the Board absolutely involves the International market. See page 7 of 7, where it talks about Vdex’ International Expansion. Perhaps it is not a big deal, someone else would know better than I about that.
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Post by ktim on Jun 16, 2019 13:47:36 GMT -5
All of this will be MOOT if MNKD announces a new marketing partner on July 2nd. A partner with deep pockets that will take Afrezza to the next level. I feel VDEX knows about an imminent deal and are trying to get in the middle. The new partner will handle all future trials to improve the label and expand the brand. VDEX is making this move out of desperation. I think you are setting unrealistic expectations for July 2, 2019. I would hate to see the stock price plummet on July 3 if there were no big announcement on July 2. The hopiod addicted crowd always thinks something wonderful is around the bend. It's not going to move the needle on the stock price.
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Post by sayhey24 on Jun 16, 2019 13:59:52 GMT -5
VDEX needs funding. For clinics to sprout up all over the place in these non-utilized states is going to take a lot of cash. 300 patients, if that truly is the amount VDEX has is equal to the same patient pool of 1 maybe 2 large endo practice(s). MNKD truly needs a big Pharma partner that is loosing market share to alternative diabetic medications. Now that Mannkind has the necessary protocols (as proven in their studies) for patients to have success, they can partner with a company that is motivated to have the market share that Afrezza deserves. The beauty with one of the big Pharma is they have connections to every endo out there, allowing their reps to persuade doctors and patients. They probably have more sway with the FDA and ADA. I believe the initial Sanofi partnership was doomed from the beginning for multiple reasons. Mannkind is not there anymore and neither would be a future partner. Great post, good points. Just saying...Vdex has their funding now, they are ready to roll:-) but they need to have some protection that they won’t get copycatted. Sports - I sure hope you are right. VDex has never had funding in the past and in reality is not really the company running most of the clinics. It has been a confederation of other mostly under-funded entities. To open 10 clinics in the Philadelphia area over a 2 year period I estimated a minimum $5M would be needed. Are we now saying VDex as secured $50M. I hope they have.
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Post by matt on Jun 16, 2019 14:36:48 GMT -5
I have dealt with literally hundreds of deals in the industry and what Vdex put on the table cannot be called a proposal because it is simply too vague to be enforceable in any practical sense. However, what they did tee up is an offer to engage in serious discussions with management and the board should consider it.
Talk is cheap and merely having discussions alone binds neither side to a deal. There may be valuable ideas tossed around by both sides, a bottle or two of red wine is a wonderful lubricant for brainstorming sessions, but at a minimum it is hard to walk away from such discussions without some new ideas in your head that had not appeared before. I suspect that Vdex has tried to engage management in discussions previously given that they issued a public letter to Mannkind shareholders (that is a very hostile tactic that you only try as a last resort, similar to an unsolicited tender offer). If Vdex hadn't previously approached management on a confidential and friendly basis then they are terminally stupid, but I suspect they are not stupid and so annoyed at being ignored that they figure there is nothing to lose.
I would have two concerns:
1. Going direct to shareholders with the letter may have so poisoned the well that coming to a friendly agreement is well nigh impossible. Once you scorch the earth, it is impossible to unscorch it. Both sides can burn a lot of legal expenses and management time working on a deal that is not going to happen.
2. Alliances that create exclusive or even semi-exclusive deals with practitioners usually end badly for both sides. The economics are not there in almost every case, and the structure of state regulated practice of medicine collides with federal regulation on prescription drugs and medical devices. Even large companies can't fight how the structure of the industry has evolved, and two small organization certainly can't either.
Still, sitting down for a chat and letting cooler heads prevail might help and can't hurt. As a former colleague used to remind me when I was at the point of despair "You already have a no, ask nicely and you might get a yes." He was a wise fellow.
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