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Post by dreamboatcruise on May 18, 2018 7:24:00 GMT -5
Call Mike and ask to become a "paid" rep for afrezza by offering to do some live demos in exchange for free afrezza. Your first gig could be at ADA giving a live demo in the hall at noon each day. I have this vision of a hi/lo you get on raising you above the crowd with a megaphone announcing a live afrezza demo. I am sure someone will say this is against some rule but sometimes you need to "bend" some rules to move things forward. We can often wish rules bend for us, but it's probably not realistic. Often it's either nuke the rules and live with the good (or bad) consequences, or navigate within the rules. * your success at bending may very I think I may have another prize... for insomnia... yeh!
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Post by dreamboatcruise on May 18, 2018 7:10:06 GMT -5
"Pinning" the price below $2 so that call options with a $2 strike price will expire worthless. An exact pin of $2.00 will have both the $2.00 calls and $2.00 puts expire worthless. About 1.67 Million shares of puts will expire in the money and be exercised as new shorts tomorrow, a little more if the price goes below 2.00. Almost 900K are $5.00 puts, so I would expect to see either those rolled forward to keep the tax man away, or sold to close tomorrow so they are not taking a new short position. I was unaware of that. There is a roll forward provision for options? Good lordy we pamper the rich with our tax laws [where is my eye roll emoji]. There aren't any roll forwards for most peoples' losses in life.
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Post by dreamboatcruise on May 18, 2018 6:18:15 GMT -5
IMO it will be AMPH who will subcontract sales to a Chinese distributor. SNY also had the right to use contractors in their Agreement. I would presume China has a handful of good distributors just like US, and any marketing partner would use them. AMPH seems highly probable for the marketing partner, though I'd love to be a fly on the wall for the negotiations I assume are ongoing.
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Post by dreamboatcruise on May 18, 2018 6:01:28 GMT -5
hellodolly... I'm way too scrutinized here* to not try to be fully transparent. The scrum dogs trying to circle would eat me alive if I ever actually make a misstatement. Hence, I am very particular about stating facts that I know to be facts vs things that I am speculating about. That can't be the worst personality fault one's encountered. *here only because of MNKD PB top down "culture" of "conformity" (can't say more because of board rules)
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Post by dreamboatcruise on May 18, 2018 5:39:15 GMT -5
Well, that explains certain encounters I've had at the pharmacy upon finding out copays were higher than the actual cost.
If Mike changes that, I'll vote him in for the first Nobel prize in combating corrupt business practices. Not holding my breath.
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Post by dreamboatcruise on May 18, 2018 4:45:27 GMT -5
Mike mentioned that they are working on termsheet for China; his global expansion map showcases details as well. I think he's hinted at it but not not really mentioned it (unless you're talking about non-webcast shareholders meeting I'm not totally privy to). Though, I totally believe China is next... of course I claimed China would close before India, so what do I know? Personally I think they got a bid from a 3rd party for China, but MNKD contractually, as well as strategically, has to offer Amphastar the deal... AMPH was interested but played coy and didn't go for the terms... MNKD is now trying to negotiate something better with AMPH before time runs out with whoever the mistress is. (sorry for being sexist... meant "alternate suitor") [Caveat: Most above is wild speculation]
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Post by dreamboatcruise on May 18, 2018 4:01:50 GMT -5
6.5 Right of First Refusal in China. In consideration of the amendments contained in this Second Amendment and in the Option Amendment, MannKind hereby grants Amphastar the right of first refusal to participate in the development and commercialization of Afrezza in China through a collaborative arrangement. Specifically, Amphastar and MannKind agree that MannKind will not commence the process of obtaining approval of Afrezza in China without first providing Amphastar with (i) at least ninety (90) days prior written notice of MannKind’s intention to commence the process of obtaining approval of Afrezza in China, and (ii) if Amphastar confirms its interest in collaborating in the development or commercialization of Afrezza in China in writing within thirty (30) days of receipt of MannKind’s notice, then the Parties shall reserve sixty (60) days to negotiate in good faith the terms of such a collaborative arrangement for Afrezza in China. In the event that the Parties are unable to agree on commercial terms for a collaborative agreement after the sixty (60) day negotiation period, then MannKind shall have the right to negotiate a collaborative agreement with another party (“Competing Terms”). MannKind shall present the Competing Terms to Amphastar in writing, and within sixty (60) days of receipt of the Competing Terms, Amphastar shall have the option to either (i) decline to match the Competing Terms, or (ii) agree to match the same Competing Terms and enter into a collaborative agreement with MannKind in China. That's the 2nd amendment not the 3rd amendment to the agreement. One might believe in bearing arms but not quartering soldiers or vs versa... or is that the constitution Question at hand is about the excluded countries.
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Post by dreamboatcruise on May 18, 2018 1:37:33 GMT -5
mnholdem - Concerning, one of the 2018 AACE Abstracts deals with a favorite subject of mine, one which I've long advocated for Afrezza. I am with you on wanting to see the official study on early use of afrezza and I just suspect some of that data may be in the "lost studies". Another study which I would like to see is afrezza's "heart healthy" effects. I am pretty sure Dr. Kendall was involved in the Jardiance study which labeled it "heart healthy" even though people were losing toes and feet. Many T2s in addition to elevated BG also have elevated LDL. By bringing down the BG to near normal ranges it would be interesting to see how much the LDL is reduced and if the hdl/ldl ratio comes back to normal. If so, afrezza not only obsoletes the anti-glycemics and the RAA but it may also obsolete the need for much of the statins. While not being able to speculate on whether your hypothesis on cholesterol would pan out, I do think that general idea of bridging Afrezza with longer term results from prior or ongoing non-Mannkind studies is very intriguing. If some shorter/cheaper (perhaps already completed) Mannkind trials can show results in some metric (lipids, PPG, etc.) that other studies link to long term outcomes such as CV, I'm sure Kendall and team are smart enough to already be working on it and know how to maximize the impact.
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Post by dreamboatcruise on May 18, 2018 1:25:27 GMT -5
It may be way early to expect a big jump in scripts already tomorrow based on the remarkable annual shareholders meeting. As the executive team executes its plan, however, I think the CEO's remark about wanting 5,000 scripts per week will come to fruition. Afrezza sales may soon be approaching the heal of the hockey stick. Sorry, just couldn't help myself Come on... even with the most amazing product launch you have to tilt the hockey stick as if a player is holding it Though if we hit that 5000 script week Mike was talking about tomorrow... repost this.
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Post by dreamboatcruise on May 18, 2018 0:54:32 GMT -5
ilovekauai... I wish I knew some way to help. I'd suggest connecting with some patient advocacy groups and conveying your results and uncooperative insurance situation. Write, write, write to your insurance. Sad state of affairs when getting opioids is probably easier/cheaper than getting a life extending pharmaceutical. I wish you the best with that. BTW... love your dinner menu... don't take offense, but that sounds very California. I didn't even know what an artichoke was until I moved out here. Now it's one of my favorite things to serve as an appetizer.
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Post by dreamboatcruise on May 18, 2018 0:42:07 GMT -5
Money talks and metfornin costs pennies per day. Insurances companies care more about cost than health. Will reduced complications offset the cost of afrezza? I don't know the answer. Well, there are two routes to get payers to cover. Prove that there is a cost savings over the relatively short time frame they use in their analysis... 3-5 years at best based on what I've gleaned from talking to execs in that business. That would require significant reduction in near term complications, which certainly wouldn't apply to replacing Metformin with any insulin early. Or... showing long term benefits and getting the medical community, ADA, patient advocacy groups, etc. behind it and having patients file lawsuits if necessary. Best to have both a carrot in front and a big stick behind. I don't envy management needing to negotiate with payers. This is probably the toughest nut for management to crack... and I think this is a key area where current management is on a different level than prior (i.e. much higher). It's not a done deal obviously, but I'm at least quite optimistic. BTW, I could say where I'm less thrilled with management... but I'll leave it at that so as to try to fool all those that know I'm getting paid big bucks by Novo to kill Afrezza one small retail proboards investor at a time
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Post by dreamboatcruise on May 18, 2018 0:19:14 GMT -5
If Dr. Kendall actually gets afrezza as the standard of care for both T1s and T2s does it matter if it is ultra, near-natural or just old-school rapid? Afrezza will be the only thing which will be used when it comes to the T2s and if cheap enough the only thing taken at meal time for the T1s. Didn't he just say something about the greatest advance in insulin in 93 years? Since Banting and Best? Maybe the label should just say "Stop the Banting, its the Best". I think getting it recognized for unique properties such as pk/pd is a small step towards getting it to be the "standard of care"... but if you think all doctors are going to start prescribing it tomorrow in preference to RAAs before a chance of a label change, then yes, the label change would be unexciting. You might be putting the cart way out in front of the horse, however. It's a long journey from management saying they have a great product to having it actually be one. I believe in the Intel approach, which was to always be a bit paranoid about your lead over competitors... build something great, but never assume it was that great. I hope Kendall isn't too much into hyping how great things already are... I'd hate for him to be embarrassed by the riches before he's actually done the hard work of making Afrezza not only a monetary success but a meaningful clinical advance for significant numbers of patients with diabetes.
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Post by dreamboatcruise on May 17, 2018 20:17:51 GMT -5
It already is labeled as inhaled. I don't think the FDA actually creates categories quite like you imagine. The FDA label certainly makes the route a prominent distinction... and MNKD can and does claim to be the only inhaled insulin. But whether doctors or payers give some significance to that is up to them, not the FDA. Yes, we all now that but people have no clue there is an inhaled insulin which is my point. Right now Afrezza is mixed with the rest which I think the FDA does have a role. Route of delivery actually is a field used to categorize in FDA database and Afrezza certainly is in a different delivery route category. However, insurers/doctors/etc. are free to make their own determinations as to what context that has a clinical relevance. FDA isn't going to make that determination. Insurers are free to consider Afrezza as equivalent as long as it isn't medically necessary to make the distinction... and FDA isn't in the business of determining what is "medically necessary" for purposes of insurance, malpractice, etc. Right now insurers are lumping it in with RAAs with the exception of such circumstances as severe needle phobia... where the delivery route distinction becomes relevant. Even if/when Afrezza gets ultra-rapid as a descriptor (as it already has 'inhaled' as a descriptor) in labeling, the FDA doesn't control whether any third party would consider that significant enough to not mix Afrezza in a general meal-time vs basal classification scheme. [Caveat: This is my understanding based on what I've been told by people in pharma. It's not inherently my area of expertise, and info to confirm all of this is hard to find online.]
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Post by dreamboatcruise on May 17, 2018 18:31:17 GMT -5
I would be surprised if they got "utltra rapid" and I think you are right the ADA would have to define the class. I actually never liked that phrase because it continues to compare afrezza to the analogs. What I would rather see is "Near-Natural" because its human insulin and near mimics natural pancreatic release. FIASP could never claim that. Make a category like "ultra" and FIASP could also be included. I believe Mannkind should work on a label change that puts them on a category of inhaled or oral insulin (non injection insulin). Something that identifies the transport of insulin. If they can achieve that Afrezza will be the only one on that category and Novo and Lilly would be left with their pants down. Afrezza would be the leader in oral/inhale insulin. I doubt the ultra-fast or ultra-rapid will ever happen but the studies should identify that due to the way the insulin is taken with afrezza, hyperglycemia is not longer a critical issue. It already is labeled as inhaled. I don't think the FDA actually creates categories quite like you imagine. The FDA label certainly makes the route a prominent distinction... and MNKD can and does claim to be the only inhaled insulin. But whether doctors or payers give some significance to that is up to them, not the FDA.
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Post by dreamboatcruise on May 17, 2018 18:07:32 GMT -5
i wonder if that was already submitted to the fda. Stat and hypo data could likely support that. IIRC MC indicated during the last label push that an additional class of insulin would likely be driven by outside organizations such as the ADA and that the FDA wasn’t the agency to do this. I could be very wrong with my recollection. I guess that doesn’t stop the ADA providing a well timed nod regarding the issue should the FDA request such input. I would guess that FDA would want some sort of input from ADA or other professional bodies on what should be the definition/threshold(s) of a new ultra-rapid designation. That's not something that is clear cut. Though certainly clear cut that if there ever is such a designation, Afrezza should get it as leading in all of the relevant metrics of onset, peak and clearance.
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