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Post by rrtzmd on Dec 2, 2015 17:44:29 GMT -5
Referring to the rumor, Mr. Finta later tweeted: "Not sure where this is coming from but I wont comment, confirm or deny.I can tell you that I will be enjoying some sun." Seriously? Is this some sort of silly game? Let your plans be dark and impenetrable as night, and when you move, fall like a thunderbolt. ― Sun Tzu, The Art of War "Let your plans be dark and impenetrable as night, and when you move, fall like a thunderbolt." It sounds like Sun Tzu was referring to MNKD and its stock price.
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Post by rrtzmd on Dec 2, 2015 16:33:46 GMT -5
Here is the original post from YMB: oxotnik1 • 11 hours ago Flag 49 users liked this posts users disliked this posts 2 Reply This Friday, Dec 4th, SNY flying initial adopters to San Diego's Del Mar Hilton . for weekend meetings with scientists from SNY and UCSD. Topics include dosing and who knows what else. This would not be happening if SNY planned to drop MNKD. I will get updates and let all know next week. Afrezza user posted this comment on Twitter this AM: Afrezzauser afrezzauser · 1h1 hour ago On way to San Diego till Dec 6th! If anyone would like to meet I will try to do it. Send private message. #afrezza Referring to the rumor, Mr. Finta later tweeted: "Not sure where this is coming from but I wont comment, confirm or deny.I can tell you that I will be enjoying some sun." Seriously? Is this some sort of silly game?
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Post by rrtzmd on Dec 2, 2015 11:09:30 GMT -5
It does't appear that Sanofi is all that concerned that spirometry testing is a major roadblock, according to this July 2015 interview by the American Journal of Managed Care:
www.ajmc.com/journals/evidence-based-diabetes-management/2015/july-2015/sanofi-addresses-need-for-spirometry-before-physicians-can-prescribe-afrezza
Excerpt:
Sanofi is taking steps to turn the tide. At the annual Scientific Sessions of the American Diabetes Association (ADA) held June 5-9, 2015, in Boston, the education session on Afrezza was packed with physicians seeking information. The Afrezza floor display included efforts to deal with the spirometry issue head on, such as a document, “Guide to spirometry,” which described who can give the test and how, what the parameters mean, and—most important of all—which codes to use for reimbursement, both current procedural terminology and ICD-9 diagnosis codes.
Officially, Sanofi does not see spirometry as a challenge to broader use of the drug. “While spirometry testing is required in order for a patient to be prescribed Afrezza, we do not see this as a barrier since many healthcare professionals are familiar with and have spirometry equipment in their offices,” said Susan Brooks, spokeswoman for Sanofi Diabetes, in an email to Evidence-Based Diabetes Management. “We have and will continue to make sure to get feedback and input from healthcare professionals and patients to help make Afrezza available to appropriate patients.”
"Officially, Sanofi does not see spirometry as a challenge to broader use of the drug." Well, that's fine for Sanofi, but then again, right now they don't seem particularly concerned about "broader use of the drug." Also, as I recall, at least a few reports from analysts came out alleging they did some surveys and found that spirometry was a significant issue. Have they changed their minds? Also, whether "many healthcare professionals are familiar with and have spirometry equipment" does not translate into eliminating a barrier. Other problems such as insurance reimbursement -- simply providing ICD codes does not address that issue -- and malpractice risk may weigh in as well. There was one website -- which I can't recall but will attempt to find -- that provided a full breakdown of the issues from one survey.
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Post by rrtzmd on Dec 2, 2015 10:28:55 GMT -5
Here is the original post from YMB: oxotnik1 • 11 hours ago Flag 49 users liked this posts users disliked this posts 2 Reply This Friday, Dec 4th, SNY flying initial adopters to San Diego's Del Mar Hilton . for weekend meetings with scientists from SNY and UCSD. Topics include dosing and who knows what else. This would not be happening if SNY planned to drop MNKD. I will get updates and let all know next week. Afrezza user posted this comment on Twitter this AM: Afrezzauser afrezzauser · 1h1 hour ago On way to San Diego till Dec 6th! If anyone would like to meet I will try to do it. Send private message. #afrezza So you're relying on a post on the YMB as your source? Is that wise? More relevant, why wouldn't MNKD or SNY announce something about it?
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Post by rrtzmd on Dec 2, 2015 9:31:07 GMT -5
O I c, no I have Aetna open access HMO basic Yep... the link URL even says aetnamedicare.com I think a lot of people here are confused thinking that any given insurance company only has one formulary. They all have many. Often larger companies (Google, GE, etc.) can even tell their insurance companies which drugs they want covered and at what levels. So what applies to one person with a particular insurer may well not apply to someone else... and you're lucky if you can find which formulary you actually belong to, especially if your looking at multiple plans during open enrollment. "They all have many," is an understatement. Looking further on Aetna's website, I found more than I bargained for. Here are a couple: Three Tier Open Aetna Premier PlanFive Tier Open Aetna Value Plus PlanThey show it as tier 3 and requiring prior approval and step therapy. Then there's the "premier plus plan": premier plus planIt just shows it as being tier 3.
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Post by rrtzmd on Dec 2, 2015 9:13:19 GMT -5
Amusing how short sellers have moved from Sanofi ending the partnership to EU approval is meaningless. Soon January will be upon us and no news from Sanofi will end short sellers last supposition of ending the partnership The short sellers will create any news story and continue to engender FUD. Sanofi could shout from the highest mountain that they are committed to MNKD forevermore and the next day the short sellers would be circulating a story about how Sanofi is only doing that in order to control the sales of Afrezza so that it doesn't compete with their own products. The short sellers will continue their manipulation until they have squeezed as much add they can from the stock and them move on. At $2/ share, there isn't much left to squeeze. They are now shaking out longs who are selling for the tax breaks allowing them to cover their positions. We play into their hands A "shout from the highest mountain" is meaningless. Action, on the other hand, means something. Action towards resolving spirometry issues -- action beyond just providing a link to the company's medical device division. Action towards resolving reimbursement questions. Action towards improving labeling. Even an action as simple as including afrezza on the list of SNY's" Important Options for Prandial Diabetes Treatment" in its presentation would count for something. So far, Sanofi has been the model for "inaction." Whether they cancel the contract hardly seems relevant since they don't appear to be doing much of anything anyway.
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Post by rrtzmd on Dec 2, 2015 8:52:38 GMT -5
FDA approval is practically a rubber stamp for EU approval. I am not sure what you are basing your comment on but I would be extremely surprised if as you say FDA approval a rubber stamp for EU approval. As in many other things European agencies normally demonstrate a healthy degree of skepticism as to what their US based counterparts do and decide. Furthermore, they have their own bureaucratic channels that tend to be more complicated and time consuming than those in the US. I have to recognize that I do not have first hand knowledge on how the process for approval works at the EMA, but one thing I am certain, if it was a clear shot and there were no other considerations Sanofi, obviously, could already have moved on it. The FDA is generally accepted as the "gold standard" approval body. Offhand, I know of no instance where the EMA has rejected a FDA approved drug. In terms of time required, take, for example, lenvima. Application to FDA was in 2013, while the EMA application was filed in July of 2014. In October of 2014, the FDA moved it to "priority Review Status." In February of 2015, FDA approved it. A month later the EU gave it a "positive" opinion. On June 15, it is approved by the EU and officially launched there that same day. So about five months after the FDA, the EU gave its approval, less than a year after its original EU application. Also bear in mind that simply filing an application doesn't mandate SNY following through on the whole process. At least an attempt at starting to get the ducks lined up, so to speak, would be encouraging. I don't believe the application and review process will be a significant hurdle for afrezza. It's reimbursement that is more likely to be a stumbling block.
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Post by rrtzmd on Dec 1, 2015 19:38:53 GMT -5
Aetna: 8 unit (60) cart w/dev B (brand) N (non-preferred) at walgreens Your Cost: $100.00 (90 for up to 30 days) annual cost $1,216.67 "Afrezza POW 4 (60) & 8 (30) UNIT Not covered" according to the Aetna "rxtools" 2016 formulary lookup site: Aetna 2016 Prescription Drug Search...none of the other combinations were covered either -- at least for my zip code.
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Post by rrtzmd on Dec 1, 2015 18:30:11 GMT -5
One would think that with the 2 studies completed, Sanofi could apply for EU Afrezza approval for adults. The 8000 safety trial could then be conducted on both continents. FDA approval is practically a rubber stamp for EU approval. I believe Mannkind or Sanofi could have applied the day after the FDA approved afrezza and, in all likelihood, the EMA would have granted approval. I imagine the same thing is restraining Sanofi there as it is here -- reimbursement. Sanofi is stuck either lowering the price or offering up solid evidence of cost effectiveness. Stack on receiving only 65% of the profit, and Sanofi probably isn't highly motivated to press very hard for further approval.
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Post by rrtzmd on Dec 1, 2015 10:19:02 GMT -5
As usual, shorts distort every bit of positive information to fit their suppositions. EU is easily within the realm of possibilities and may have been already applied for, but that is Sanofi's responsible to disclose. Unfortunately, Matt would not be able to answer such a question so I asked it in a way that he could. Longs, don't get discouraged, their are many good possibilities to look forward to. EU application would be a great one! No disrespect intended, but, in this case, I would argue that you are the one trying to "distort bit of positive information to fit their suppositions." Matt's response revealed nothing at all. If you had asked him whether he expected MNKD to get a $100 a share buyout bid tomorrow and got the same response, would you be looking forward to it right now?
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Post by rrtzmd on Dec 1, 2015 9:48:28 GMT -5
My own experience is that ETF rebalancing is not good for a stock. Yes, sometimes you get a bump in the price, but it often attracts the speculators and when they decide to get out, it's often all at once, and then you sit by and watch the stock get pummeled in the process.
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Post by rrtzmd on Dec 1, 2015 9:40:19 GMT -5
I emailed Matt the following question: Matt - I know this is a question for Sanofi but I am hoping you can at least acknowledge if the following assumption is correct. With the 2 studies completed, one would think Sanofi could apply for EU Afrezza approval for adults while pediatric study is under way. If the EU approved Afrezza for adults, then the 8000 safety trial could be conducted on both continents. Is my reasoning within the realm of possibilities? If you can not talk about it, could you at least acknowledge that? Below is Matt's response: "It is indeed within the realm of possibility. But the safety study could be done on multiple continents regardless. We did our phase 3 studies on three continents." "It is indeed within the realm of possibility" -- the usual Mannkind response which really tells you nothing at all.
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Post by rrtzmd on Nov 30, 2015 21:26:35 GMT -5
My own question is -- even if MNKD manages to generate adequate financing for another one or two years, are there really any goal posts -- beyond survival -- to strive towards? Afrezza is in Sanofi's hands and MNKD can do nothing but complain about afrezza's treatment, so there's nothing to really work towards there. The only other option is offered by technospheres, about which MNKD seems unwilling to discuss any firm plans for actual drugs with actual partners. Given current financial constraints, spending money there appears to offer little immediate benefit. At this point, it seems like it would be rational if the company could be put into some sort of financial "hibernation" -- if such a thing exists -- and come back in a year or two to see how far afrezza has come, and then perhaps reinnervate it. Otherwise, it's just paying the parking meter.
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Post by rrtzmd on Nov 30, 2015 20:37:24 GMT -5
Good news. Now, when do you suppose Sanofi will publish the results? The FDA did state that certain results could result in label changes, so I expect Sanofi, MannKind and FDA will also meet to discuss the data. Unfortunately, the clamp study really won't show anything new. This is highly unlikely to result in any label change. The PD profile was already in the prescribing information. This is just additional data that will further validate the PD chart we all love so much. I would like to think that the pediatric study might have been designed to actually show superiority, but I temper even that expectation because of a comment on one conference call where MNKD stated that all the "required" FDA trials would be started before the label improvement one(s) seeming to indicate they would not be dual purpose. Maybe the pediatric or some other less official trials or observational studies will generate data that will be used with payers, if not for actual label improvement. Can't doctors publish observational studies as such in respected medical journals? It would seem some of the early adopter doctors (such as ones speaking at Adcom, Sam's doc, etc.) would have quite a lot of patient data that would show meaningful drops in A1c. Is that unpublishable since it wasn't in an FDA trial? Docs can do any kind of study they want and publish any kind of data they want -- presuming of course that some journal thinks it's worth publishing. Right now, more worrisome, I would think, is the near total lack of comment one way or another about afrezza from any branch of medicine.
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Post by rrtzmd on Nov 30, 2015 12:22:17 GMT -5
Exactly! I've been thinking the same since the very beginning. All this talk about a "pilot" program yet scripts are closely monitored and discussed. If this was a pilot neither SNY nor MNKD would seem concerned. Both have expressed their dissatisfaction with sales. What puzzles me is how they even expect the product to sell without a proper large scale advertising campaign. I've spoken to at least a dozen diabetics and not a single one of them knew about Afrezza. To be brutally honest, none of them even seemed interested despite the great results and ease of use. Diabetics are a strange breed. Most don't seem to care much about properly controlling the disease. They are so set in their ways and cynical about any sort of new treatment. Sam Finta said it best when he said most diabetics are walking around not aware how sick they are and the damage they are causing to their organs. I've witnessed first hand the damage this disease inflicts, and it's not pretty at all! What you say about patients is likely especially applicable to T2. From the beginning of the disease they are told that if they get their act together they can stop/reverse the disease with diet and exercise. Each progression in treatment involves some degree of self admission to failure. I think many simply wish to think as little as they can about the situation. Unfortunately, the current prescribing regimes of orals almost assure that the disease will worsen. It will be important to have doctors on board because I suspect many T2 would need to be pushed into initiating insulin... even if it is more patient/lifestyle friendly version. Current protocols from both the ADA and AACE put prandial insulin as the very last resort in attempting to control hyperglycemia in treating type 2 diabetes. For obese patients, even bariatric surgery now ranks higher: AACE type 2 protocol
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