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Post by joeypotsandpans on Feb 11, 2016 16:48:45 GMT -5
For whatever SNY's reason(s) for not dropping the price, to me that combined with ole Margaret's mark that she left regarding the label, and "non inferior BS trials" are pretty much the ONLY factors that hampered the launchI don't disagree, but that's a bit like saying the iceberg was the ONLY factor that hampered Titanic's voyage  Lol, not quite DBC, not really knowing all the circumstances regarding who might have been asleep at the helm, but would have to believe there was human error and the iceberg could/may have been avoided....MNKD could not avoid the wrath of Hamburg and how shall we say...HER GLARING CONFLICT OF INTEREST, etc...along with what continues to be a securities industry that Mr. Sanders would love to get his hands on, no secret why Bernie's popularity has soared in direct correlation to his views of "the street"....just "feelin the Bern" as they say when it comes to MNKD et.al. |
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Post by joeypotsandpans on Feb 11, 2016 13:22:29 GMT -5
www.fiercepharma.com/story/sanofi-tried-and-failed-afrezza-why-does-mannkind-still-think-it-can-win/2016-02-10 Excerpts follow. Those obstacles are indeed daunting: To get access to the drug, patients have to undergo lung testing with a spirometer, which isn't a common piece of physician-office equipment. The testing was "a major hurdle," JPMorgan analyst Cory Kasimov said last year, and that requirement, along with the FDA's cautionary language about breathing difficulties, made already wary doctors even more so. The truth is, Sanofi may have overestimated the appeal of an inhaled product over an injected one. It may have over-attributed the failure of Pfizer's ($PFE) inhaled insulin, Exubera, to the unwieldy design of its Pringles-size delivery device. But even among the 6,000 patients who wanted the inhaled product, only 35% stayed on the drug, a Sanofi spokeswoman told the WSJ. MannKind appears set to ignore those statistics. Pfeffer maintains that patients want a needle-free option and sees Afrezza's whistle-shaped device as the answer. To him, Afrezza would have been fine if it had been priced lower and earned better coverage with payers.
After Sanofi ended the partnership, Pfeffer said he'd look for a new partner and cut the price of the drug. Priced at a premium to injectables, Afrezza sits on most payers' third tier for reimbursement, the WSJ says, and Pfeffer says pricing and reimbursement "dramatically outweigh other factors" that hampered the new launch.
Future Afrezza plans have to involve educating patients and doctors, as well as improving patient access, Pfeffer said on a call with analysts last month. He believes patients really are clamoring for a drug like Afrezza, even with all the evidence to the contrary. Why? " The real world experience of Afrezza users ... is everything we hoped it would be," Pfeffer said during the call, vowing, "this is not the end of the line for Afrezza or MannKind by any means." Umm, wonder if Cory still believes that about the lung function testing....on my visit with my primary, they wheeled in the Spirometer, and it was quick and easy, exhaled 3 separate times into the tuby thingy. I'm not sure what SNY over or underestimated but this cat doesn't have the word needle, pen injector, etc in his vocabulary Agree with it being fine if priced competitively, as I currently have my primary handling the PA For whatever SNY's reason(s) for not dropping the price, to me that combined with ole Margaret's mark that she left regarding the label, and "non inferior BS trials" are pretty much the ONLY factors that hampered the launch Looking forward to "the real world experience of Afrezza" as I'm confident it is everything and more than advertised currently. I am currently following the normal protocol for getting my script covered, if it becomes a bigger challenge and the insurance co. decides to dig in their heels, I have already looked into and am prepared to take it to other levels and means. As Neil Page would say "you're messing with the wrong guy" |
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Post by joeypotsandpans on Feb 8, 2016 11:27:56 GMT -5
According to most analysts, this drug was never going to be on the market either...if you're in the habit of listening to analysts you have an entire educational process you will need to go through. First lesson, the analysts are not there for you As for the latter part of your statement, most analysts also said that MNKD would never have a partner in the first place. The original partner, I say original in jest meaning the original CEO that got displaced by the board because he wasn't a follower but a leader was replaced by an idiot that ultimately will be shown (IMO) to have made a huge error in judgement and possibly liable in totally disregarding properly pricing the product to effectively compete. Cannot speak for "other companies" that may see where the original so called partner failed. |
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Post by joeypotsandpans on Feb 6, 2016 23:12:30 GMT -5
Joey, why do I have a feeling that you will be buying a CGM next? If the disease is early enough in its progression, perhaps it's not to late for your insulin therapy to restore normal insulin production. It would be fantastic to have a documented case where Afrezza led to remission of this disease. MN, based on what I've read and the various testimonials touting the benefits, along with my conversations with Spiro, I'm optimistically confident that I won't need the CGM. Hopefully, after a few weeks of monitoring via the finger sticks I will have a pretty good gauge on my dosing per meal etc. The beauty of A is that it eliminates rocket science, I won't have any fear of hypo so if I over correct a tad here and there it shouldn't be a big deal. As a T2, I doubt I will need to be as obsessed with the range as a T1 might need to be. Anything I get between 90 and 120 will be far better than where it's been. The fact that my primary was so open minded encourages me to "shock" her in 90 days and expect her fully to become another advocate and believer for the huge practice that she belongs to. The rep is visiting with her Monday to piggyback my visit and help with the insurance paperwork. |
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Post by joeypotsandpans on Feb 6, 2016 22:53:35 GMT -5
joey, you are so cool. Thanks for telling your story! It helps so much to hear some of what is really going on! All the best to you:-) Every time I read one of matts posts I want to eat carbs! So I understand how hard it is. You pulled me over here from YMB. Seems like years ago now. Glad you did! sports Thanks Sports! As far as the posts that get to you, well I've come to realize there are some on here that have had lapses of oxygen to the brain at some point in their lives and quite frankly can't help themselves so you're best off to just not waste time reading or block the ignorance. Happy to share the facts and glad you're here, stay well |
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Post by joeypotsandpans on Feb 6, 2016 16:21:13 GMT -5
Joey, nature might be working against you my friend, so keep that in mind. I'm learning all about leptin right now- the hormone that gets secreted by adipose tissue... When you lose weight, there is less adipose mass, thus less leptin in the system. Leptin helps suppress appetite and increase your RMR (resting metabolic rate). So it's going to be challenging for you to keep the weight off, both from a psychological standpoint (saying no to your favorite foods that cause dopamine release- ie. happy foods) as well from a biological standpoint- your body no longer is helping you... But so glad to hear you're getting your health under control. I hope that Afrezza will help you further meet your health goals! I just got the crazy idea that we should all get our blood work done right after consuming a pack of Sour Patch Kids so we can all have this talk with our physicians! P.S. It was really cool that the rep was so helpful and compassionate. But also really bizarre that his opinion was such that the drug would fly off the shelves if they matched the price of other RAAs. Seems to conflict with what he said about not believing SNY wasn't holding back. I wonder what the rationale was for keeping the price high if that was the perceived biggest barrier. I know others have stated they thought SNY was sandbagging the whole time, which is highly likely, but I'm wondering if they just thought they needed to have a set price per unit to meet their expectations for some reason. Still don't get why SNY wouldn't just buy Afrezza from us if they really thought that it would fly off the shelves with a better price point... Stevil, I have read a fair amount of your posts, I get where you're coming from as my oldest is a first year resident and has a seven year fellowship path in HEMONC, my youngest is first year PHARMD student and had his first paper for one of his courses on Janumet (why I knew where my PC provider was going so fast) and finally my wife has been an ICU RN for the past 30yrs. So trust me when I tell you I have gotten the speeches regarding my medical situation more than I care to say lol. Even though they are aboard of the benefits of A. they get first hand how difficult the obstacles are between insurance and fundamental economics surrounding the situation. For example, the particular county hospital my son works at as first year resident, when i asked if he has had the opportunity to prescribe A. he stated the following, "dad, you have to understand how indigent the patients I see are, I'm fairly limited on what I can prescribe etc." ...to which I responded I get it. I also get why he is destined to continue down the research path as opposed to clinical for that matter. Regarding your statement about what seemed to be a bizarre contradiction regarding the price statement and not holding back, see my response to sekc regarding same. My guess is at 65% and what may have been agreed upon initially they didn't expect as much push back from getting it accepted on Tier 2, and economically for them (SNY) they weren't willing to drop for whatever "net net" reasons. Again, the reps aren't privy to the back office number crunching, etc. |
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Post by joeypotsandpans on Feb 6, 2016 15:46:43 GMT -5
they did state they did not blame SNY for not doing more advertising in the way of national TV ads as stated before because without the insurance issue being resolved it would have only caused more problems. Again, after our lengthy conversation I can fully appreciate what this rep in particular had done over the past year. One of their last comments to me was "i f the price dropped and was competitive with current RAA's this would be flying off the shelves"...nice to hear that from a rep I am not sure if Congratulations is appropriate but atleast you are in good hands of Afrezza . Hope you can maintain better blood sugar range and overall health. If SNY field rep can analyze the road blocks , they would have mentioned this to management. How/what prevented SNY from reducing the price and gain insurance coverage when they has 6 months from the deal signing to launch and then a full year? What prevented them from getting a superiority trial 6 months into the market? and the main Q.. Did you have insurance issues with your prescription getting filled? and hopefully your primary doc now will see the results and Afrezza first hand Thanks Liane and "sekc", one big takeaway from the rep is how separated SNY HQ was from SNY US regarding the fact that the rep basically stated to me they found out when we found out....in fact, the very day of announcement they were headed to a care provider with a lead trainer who also found out right then and there, they still proceeded with their visit/meeting and were emotionally spent as they informed the physician and he stated to the trainer "you know who i really feel sorry for is the individual sitting in front of me who has spent the last year working their butt off on this as one day some other rep will get the fruits of their labor". They are now representing Toujeo and are extremely bored and still fully supportive of A. I asked about the price issue and they stated that's back office and they are not privy to the whys and hows of the pricing, etc. They did state they fully understand why Matt would make the statement that they have the research numbers etc., and why they (MNKD) are confident about the information feedback they have gotten going forward, as this rep feels like they played an integral role in providing that feedback to SNY mgmt. Regarding the prescription, it did come back not covered (no surprise there as I didn't expect it to be having already discussed my provider with the rep previously), that is why they offered to visit my primary care individual on Monday and asked for the print out so they can start the appeal process. Btw, I would consider congratulations an appropriate term sekc, to me right now I consider getting the script 50% of the accomplishment (the other 50% getting it covered)....keep in mind when the pancreas becomes challenged, to me this is first in line and best in class and only alternative I personally am willing to consider having done my due diligence (quite a bit more so than Margaret and her flunkies IMO) regarding this SUPERIOR drug/technology again IMO, which I'm confident when the properly designed trials are done will illustrate. |
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Post by joeypotsandpans on Feb 6, 2016 14:57:49 GMT -5
Here are some FACTS: I met with my primary yesterday, young primary from NY with a positive attitude. A little history, I met with a prior PA last January before A was approved and when she said I may need an insulin regimen depending on how I did on "the pills route" I mentioned A and inhalable insulin which should be launched very soon. Her attitude was immediately defensible stating if that's what I wanted she would have to refer me to an Endo. Subsequently, I was introduced to the SNY rep that I've mentioned in the past and in our conversations late spring/early summer the rep told me that the PA had been invited to the educational dinner seminars and no showed. We'll get back to that in a few. I wanted to try the "diet and exercise" route as a first line defense if possible. I did lose close to 20lbs (I was never overly obese but for 5'10" about 205 what I would term the typical overweight middle aged to senior male (55) and managed to get down to 185). I cut out what I term the 3 starches bread, potatoes, and pasta and started on the elliptical. Here's the problem for me, no excuses, but I don't drink or smoke and food is one of life's pleasures that I've always enjoyed. Going into my pizza man's place I could only pass up the garlic knots so many times and eat "the Joey salad" so many times...I could only pass up the baked potato with my filet so many times...etc. Then the holidays came and it was essentially game over. So as I mentioned to my buds on this board who know me on a daily basis, I said I would get my blood tested again (full metabolic, etc) after the holidays passed and set up my appt. one year later. Which brings me to yesterdays appt. In Dec. I had dinner with Spiro and a few others and Spiro left me with one of his dreamboats. I brought that to my visit yesterday in anticipation that the new physician I would be meeting with might not be aware of A. After meeting with the nurse first getting the routine stuff out of the way ie., weight, BP, routine questions answered etc., my new primary came in. After the initial intro and questions, we got into the blood sugar discussion. We talked about the metformin regimen I had been on, and then she started on the "combo" pill she was going to recommend...I stopped her in her tracks and stated "don't bother with the Janumet speech". She seemed a bit taken aback and then I pulled out the dreamboat Spiro gave me (thanks again Spiro, I can't begin to tell you the "mileage" a used dreamboat can get as far as conversation starter with people who are either diabetic or know or are close to one). She had not seen nor heard of it, but to my pleasant surprise was very open minded and receptive. She listened to what I had to say for a few minutes and excused herself with her laptop and stated she would be back in a few. Upon return she started to state "ok, but I have to tell you a few things" and I said go ahead but I already know full well about the "black label" warnings...she said I know but I still have to state them. She then said I would need the spirometry test and the nurse would be in to perform it. I was thrilled that they had it right there and a little surprised that things were moving along so fluidly. Spirometry test completed, she comes back and says you passed so I am going to prescribe but just so you know it might be expensive, and I want to see you back in 90 days. They escripted to my CVS and after finishing up my visit I immediately proceeded to my CVS. On the way to CVS, I called the SNY rep I know and they stated "that great! but now you might encounter the biggest issue/wall we've had, let me know if they state if it was rejected and if so ask them to give you a print out so on Monday I can get with your provider and SPC (Sanofi Patient Connection) to appeal. I've come to learn and appreciate this person (rep) as a proactive and huge supporter of A. So much so, I inquired if they would be willing to talk with Matt and they stated they're always open and mentioned their connection with other "team" members that felt the same way (In my email to Matt, I am highly encouraging him to contact this individual). There is a lot more from that discussion that I can tell you was eye opening and positive. One thing I will say is they did state they did not blame SNY for not doing more advertising in the way of national TV ads as stated before because without the insurance issue being resolved it would have only caused more problems. Again, after our lengthy conversation I can fully appreciate what this rep in particular had done over the past year. One of their last comments to me was "if the price dropped and was competitive with current RAA's this would be flying off the shelves"...nice to hear that from a rep I actually thought about changing my handle to JoeyFrezza lol, enjoy your superbowl weekend and try not to "carb out" too much... |
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Post by joeypotsandpans on Feb 3, 2016 19:08:16 GMT -5
Good summary. The call was mostly positive and helpful. I find it interesting that the Shoutbox was so negative.The two main negative items: 1. TS pain is apparently on the backburner (though I'm not surprised because of cost) 2. MannKind isn't able to make changes to Afrezza pricing/marketing strategies until licensing transitions back to MannKind (this may take longer than expected). The main concern is obviously cash burn until Afrezza sales can be turned around. And, new partners and milestones payments aren't likely to show up for a while. The positive: MannKind remains committed to Afrezza/TS and Management no longer appears apathetic to shareholders. I think the company is moving in the right direction. The Stock is still a HOLD but I feal that the stock is undervalued here. If I had to pick a number I'd say MNKD is worth 3$, but I'm not buying until another partner steps forward. The first partner is likely an international Afrezza partner, but Sanofi needs to go away first.
Anyone that thinks/claims SNY has any case whatsoever of a commercially reasonable effort to market Afrezza is FOS. Matt was pretty diplomatic in his description of his thoughts about that as well. When one of their (SNY) own reps is willing to make a change because they still believe this is a phenomenal product for diabetics, well like I said in a previous post, that speaks volumes. A few magazine ads, etc. does not cut the mustard for a revolutionary breakthrough product...label restrictions and all included. Personally, I would have loved to ask Matt what his and/or Al's thoughts were about the this www.aboutlawsuits.com/levaquin-rico-lawsuit-93357/ which has been brought up but shouldn't be taken lightly IMO. |
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Post by joeypotsandpans on Feb 3, 2016 14:26:21 GMT -5
Clearly you do not understand what I was saying. Dictatorsaureus described it perfectly, and then you went back in your own direction. You're the only one who suggested that ground level local reps where acting on "C-suite" orders. I believe my experience with this rep is just one example of what has happen across the country. INSTEAD of SNY's sales reps influencing and changing the old school ideas of docs & endos, by supporting and educating on Afrezza, they themselves were influenced by the push back against Afrezza and got on board with it. Almost as if they were embarrassed by their little sister, and now, they're saving face with the rest of the industry by jumping on board with the "yea I knew it wouldn't work either" attitude. That attitude from the SNY reps is what scared me the moment I heard SNY was splitting. If we couldn't gain traction with an ally like SNY, then how the heck are we going to get anywhere when they're against us too? Not to mention, they're supposedly "with us" until the agreement is over which is an absolute JOKE. All these reps are out saving face and probably have more negative comments on Afrezza than our competition does. OH YEA, let's add that our money will run out close to the time we can even get Afrezza back in MNKD's hands. Sry folks,,, not feeling too optimistic today. You all can use beer, wine & liquor to ease the pain but none of them work for me any more. A tall picture of Kool-aid is the only thing that helps me sleep. A near term buy out of something is the only way I can see us surviving, and I hope that is what all the recent moves have been setting up for. You are correct, I did not pick-up on your point from the original post. I now get it, and agree with you. Just an fyi, the rep I know felt quite the opposite of what was stated here...they still believe in the product, so much so they stated they would entertain making a move to continue to represent it. Pretty strong statement if you ask me |
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Post by joeypotsandpans on Jan 27, 2016 16:34:39 GMT -5
123,892,191... 8.8 days to cover ( previous period was 120,719,394) Sanofi pulls out of partnership, 71 million shares trade on Jan 5 and 6. And Short Interest has increased by more than 3 million shares. Wow, just wow! I wondered whether or not Shorts may have been able to cover 10 or 20 million shares. But NO!   And the 8.8 days to cover is an absolute joke! I have watched the market closely since the last announcement. I'll guaran-dang-tee that there has absolutely NOT been any significant short covering until maybe today. I can't prove it but I KNOW that the true share volume from genuine, retail traders is several hundred thousand shares a day..... AT MOST. 95% or more of the daily volume we see is just Wall Street crooks playing with the share price all day long. Trading back and forth between themselves. I'm telling you, if Shorts have to acquire shares from genuine longs, the Days to Cover is closer to two months than it is 8.8 days at the current level of volume. I posted previously how impressed I was with Matt and Ray's conference call. I thought it was terrific. Coupled with today's Short Interest news I am much more optimistic than I have been in a long time! ^^^^ Alethea gets it |
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Post by joeypotsandpans on Jan 26, 2016 20:32:09 GMT -5
Anxious to see the numbers tomorrow after the close, could be very telling IMO.....if I were short, I would not be feeling very comfortable should that number remain near nine digits after the 15th of this month. |
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Post by joeypotsandpans on Jan 21, 2016 8:19:15 GMT -5
TY for the very nice start of the day, Klayman not a fan of the individual in office either. He filed a petition to have Obama deported as well (fraudulent birth certificate issue), it's about time the bitch and her scumbag excuse for a human husband get exposed...most likely just the tip of the iceberg also, they have no conscience and there was no limit to the extent of which she abused her power. I sincerely hope Al is alive to see them go through hell and back again. Settlement should not be an option for the defendants in this case IMO. Again, thanks for making my day |
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Post by joeypotsandpans on Jan 15, 2016 14:10:25 GMT -5
Yup, and next month those lovely warrants will expire worthless, absent a miracle. I traded those quite a while back for Jan 2017 call options, smart, but not smart enough! Today, my fellow posters, with respect to MNKD stock, we are seeing what is often called a "flight to quality" in the midst of this raging market sell off! I hope CNBC is noting same! Truer words cannot be spoken, you may have been typical Baba sarcastic but I'm not |
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Post by joeypotsandpans on Jan 14, 2016 19:52:46 GMT -5
Right now is not the time to spending resources (both financial and human) on this. If you think about it the more successful they can make Afrezza either on their own or with another partner would only validate the fact that SNY was inept, apathetic, and not fully committed to seeing it become successful which in turn would elevate the potential damages from the time lost of their failed so called launch/efforts. We need to pursue/address that issue from a better position of strength down the road, not when we need to allocate the aforementioned resources to gaining traction going forward. Having said all that, if they ponied up a DECENT kiss goodbye fee, it would be prudent to at least consider it. Otherwise, prove they mishandled it by showing just how successful it should have been even before any label improvement. If you do that, they would be hard pressed to defend their ineptness and lack of fiduciary responsibility according to the agreement.
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