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Post by mango on Dec 30, 2016 21:09:50 GMT -5
When I try to sum it all up, I keep getting the FDA + Sanofi.
Restrictions on use forced by the FDA and Diabetic guidelines for standard practice are too limiting, causing endos to hesitate and Insurers to balk. The really smart investors started selling the minute we got approval because they saw the hatchet job the FDA did to our product's chances. I didn't see it because it was my first product launch. Many here didn't either. But, I believe the GS types saw the writing on the wall.
And then, there's Sanofi. I'm looking at the 3 year chart now. Some people knew something was off with the Sanofi partnership because they started selling right off the bat. The only valuable info they had received during that few month period at the top of our price climb were the FDA restrictions and the Sanofi partnership. JMHO but I believe it starts and ends with those two factors. Any physician with common sense would know that it would take far far far more cash than what a one man funded company can afford to do all the trials required to NOT have those black box warnings. Al Mann couldn't afford to pay for every single study arm to prevent that, so they did what they could afford beyond what would be required. Had Mann had an extra 10 billion laying around maybe they could have done all those other study arms to prevent those required warning. It is seriously not an issue to have those warnings. Do you know all the black box warnings for Viberzi? It is owned by Allergan and despite all the actual horrible side effects that really do occur, it is very successful lol. Why is that do you think? Lunches, attractive people, favors for friends, lunches, and the name Allergan also helps too. Black box warnings don't really have the "Oh my god!" Effect people think it does. Ironically, the FDA has not received any complaints about negative side effects from Afrezza and there are no known hospitalizations associated with it. The problem arrises with the fact that Technosphere can be utilized for and with nearly anything. It is interesting to read all of Sealantis' international patents (AMIT spinout that Avi Kerbs and David Hankin are BoD of. Hankin is also CEO of AMF). Technosphere can be utilized in far more advanced ways than an inhaler. Don't be suprised when you see it utilized within a biodegradable fibrous mesh in conjunction with 3D printing. People want to be quick and say everything is irrelevent blah blah blah. Those same people don't read the patents and latest info from all the Al Mann related companies and MannKind partners. Type in technosphere into wipo search and take a look at all the non-mannkind affiliated companies that are using not only technosphere in their parent descriptions, but even specifically mentioning dreamboat and the cricket!!
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Post by Deleted on Dec 30, 2016 21:31:23 GMT -5
The slides also state the business model the clinics have position them in a way to be able to produce hundreds, yes hundreds, of clinics during 2017-2018. Majority of skeptics fail to realize exactly how much money William McCullough generates through being the owner of SHR which is also affiliated with a very large and renowned elite Beverley Hills practice and has numerous connections around Silicone Valley etc. Few have paid attention or even read the SHR website. It is kind of a foundation and a prelude to what is to come and what to expect. William McCullough actually adheres to the same kind of philosophy as Al Mann. He truly wants to help people and only have the best and always strive for innovation. SHR does not do any TV advertising, they are strictly a word of mouth multi-million (prob billion nearly) business that became this way just through word of mouth. Usually top quality products/services are those you hear about from your best friend or acquaintances. If someone truly likes and benefits from something and has a great experience, they will talk about it. Top quality sells itself. All of this is just IMO of course. Therebisbno telling how many wealthy millionaires McCullough has helping with Vdex. It could be a national prong approach for all we know. We do know that they definitely have the funds and the connections. speculate much? multi million - probably billion? ok. I agree with you. Hope he is buying mnkd stock under the radar. You know 100 million shares under a $1 ( its been trading all yr under that ) , thats 20% of the company would only cost him $75 million. wealthy millionaires and vdex.. do you have drinks with Bill that you know so much about vdex operations and funds and connections?
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Post by sophie on Dec 30, 2016 23:22:10 GMT -5
This is a very good thread. Thank you Mango for your research and reporting it. Thank everyone here for your contributions. Keep up the good work. Research? Where? We should vote to give mango an honorary MD on this board because he knows so much more than nearly every practicing physician. I'm actually quite enjoying his rants. Carry on
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Post by careful2invest on Dec 30, 2016 23:36:56 GMT -5
Restrictions ultimately mean crap. I see tons of physicians say, "I was reading a study/a new study came out let's give it a try and see what happens." Part of the job of a physician is being able to evaluate data and studies, use common sense, and practice medicine. You aren't practicing medicine if you are doing an outdated procedure/technique or utilizing the same harmful and ineffective drugs and regimens if there is significant evidence to suggest your methods fail and are unsuccessful majoirty of the time. Practicing medicine is the ones reading studies, asking questions, seeking answers, and utilizing and trying the newest things they read and hear about when the right time arrises, which will arise, because a true care providor isn't aftaid to try and fix the problem and make mistakes or successes and thus learn and contribute to advancing medicine instead of being a robot. Can you show me those studies with significant evidence? Blame docs all you want. It's MNKD's fault for not proving superiority. Docs are just following the studies that have been done. Those studies are usually done by pharmas. They're doing the best they can with what they've got. And you wouldn't last long as a doc with that mentality. You'd have so many lawsuits you wouldn't have a cardboard box over your head by the time lawyers were done with you. Sophie, The fact that AFREZZA has not been officially proven to be superior, begins with the way that the FDA set up the trials for AFREZZA. They only had to prove to be non inferior! And the way that the FDA set things up, (having the participants inhale AFREZZA so early before their meal) We are lucky that AFREZZA did not fail. That was not MNKDS fault! MNKD had to follow the protocol! You should understand that! Has MNKD crossed every t and dotted every I? Unfortunately not! They have made major mistakes and at the same time overcome major hurdles. I do not claim to understand the MO of MNKD, and honestly have had a different opinion of what MNKD should have been doing as opposed to what they are actually doing, but it's out of our hands. We investors have been left in the dark with basically only speculation as to where this company is going. For years! I have owned MNKD for about 7 years and I realize that I have said these words before, but I honestly feel that we are going to get some very positive news from MNKD in the very near future. Maybe it is optimist hope, but it appears that many components seem to be gaining allignment to get us to a successful point. Regardless, It is crunch time either way! Time will tell! GLTA TRUE LONGS!
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Post by mnkdfann on Dec 30, 2016 23:53:53 GMT -5
This is a very good thread. Thank you Mango for your research and reporting it. Thank everyone here for your contributions. Keep up the good work. Research? Where? We should vote to give mango an honorary MD on this board because he knows so much more than nearly every practicing physician. I'm actually quite enjoying his rants. As am I. "Here we are now, entertain us." youtu.be/hTWKbfoikeg
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Post by mango on Dec 31, 2016 6:09:05 GMT -5
The slides also state the business model the clinics have position them in a way to be able to produce hundreds, yes hundreds, of clinics during 2017-2018. Majority of skeptics fail to realize exactly how much money William McCullough generates through being the owner of SHR which is also affiliated with a very large and renowned elite Beverley Hills practice and has numerous connections around Silicone Valley etc. Few have paid attention or even read the SHR website. It is kind of a foundation and a prelude to what is to come and what to expect. William McCullough actually adheres to the same kind of philosophy as Al Mann. He truly wants to help people and only have the best and always strive for innovation. SHR does not do any TV advertising, they are strictly a word of mouth multi-million (prob billion nearly) business that became this way just through word of mouth. Usually top quality products/services are those you hear about from your best friend or acquaintances. If someone truly likes and benefits from something and has a great experience, they will talk about it. Top quality sells itself. All of this is just IMO of course. Therebisbno telling how many wealthy millionaires McCullough has helping with Vdex. It could be a national prong approach for all we know. We do know that they definitely have the funds and the connections. speculate much? multi million - probably billion? ok. I agree with you. Hope he is buying mnkd stock under the radar. You know 100 million shares under a $1 ( its been trading all yr under that ) , thats 20% of the company would only cost him $75 million. wealthy millionaires and vdex.. do you have drinks with Bill that you know so much about vdex operations and funds and connections? Are you even aware as to how successful SHR is or even aware of who they are partnered/affiliated with? SHR literally has several world renowned surgeons with their group and are extremely successful and have been around a long time. Yeah, I am more than sure he is a multi-millionaire. Why does he have to purchase a significant portion of MannKind stock? Why is that something you think must be done? He is a business man and is creating diabetic clinics now. He is doing it for obvious reasons that does not take much effort to realize. There is even an entire section of their website dedicated to Al Mann. I know what I do because I have looked into it. Millionaires are not an uncommon thing and Vdex is a real company so not sure what you are even trying to say.
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Post by agedhippie on Dec 31, 2016 7:49:42 GMT -5
Most up to date and open minded physicians kinda make their own best practices while their counterparts are still doing what has always been done and has nothing to show for the decades of repetition and copying and pasting. Most all docs do things their own way. Prescribing Afrezza is not a malpractice liability concern and it is absolutely disinformation to suggest it is. It is an FDA approved medicine and device. If benefit outweighs the risk is an acceptable ideology for physicians to utilize daily, prescribing a new innovative diabetic drug with a new ROA that is FDA approved should be a no brainer. It is providor laziness and their lack of interest in utilizing something new vs what doesn't work but everyone does it anyway. This goes for every field not just endo. Seems like EM docs are an exception from my experience though. Why do so many anaphylactic cases present in the ED? Because the patient either waited til the last minute to stab themselves, refused to stab themselves, or never had an epipen with them. A pocket sized inhaler that doesn't harm you would fix that. How many patients have been admitted for something directly insulin therapy related that were on Afrezza vs injections? Facts don't lie. The problem with what you are saying is that the studies do not support superiority, exactly the opposite. At this point somebody usually jumps in and blames the FDA - well Mannkind set the protocol not the FDA. There were multiple trials so there were a lot of chances to get this right. Don't blame the doctors if they trust the trial data. I do agree though that there is no way that a doctor gets hit with a malpractice suit if they prescribe Afrezza rather than Humalog, has anyone actually said that? Epipens and insulin are completely different cases. One is used very occasionally and the other is used several times a day. Yes, I might hesitate to use an Epipen because I am not used to it, I expect it to hurt, or the cost - insulin is something I use several times a day so it's no big deal and I know it won't hurt. Given the ratio of injectable insulin users to inhaled insulin users I would expect there to be hugely more of the former than the latter. Just to clear up this myth that insulin users live in ER with hypos - in 40 years I have never been in hospital because of a hypo, DKA yes, hypos no.
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Post by od on Dec 31, 2016 11:19:49 GMT -5
When I try to sum it all up, I keep getting the FDA + Sanofi.
Restrictions on use forced by the FDA and Diabetic guidelines for standard practice are too limiting, causing endos to hesitate and Insurers to balk. The really smart investors started selling the minute we got approval because they saw the hatchet job the FDA did to our product's chances. I didn't see it because it was my first product launch. Many here didn't either. But, I believe the GS types saw the writing on the wall.
And then, there's Sanofi. I'm looking at the 3 year chart now. Some people knew something was off with the Sanofi partnership because they started selling right off the bat. The only valuable info they had received during that few month period at the top of our price climb were the FDA restrictions and the Sanofi partnership. JMHO but I believe it starts and ends with those two factors. Any physician with common sense would know that it would take far far far more cash than what a one man funded company can afford to do all the trials required to NOT have those black box warnings. Al Mann couldn't afford to pay for every single study arm to prevent that, so they did what they could afford beyond what would be required. Had Mann had an extra 10 billion laying around maybe they could have done all those other study arms to prevent those required warning. It is seriously not an issue to have those warnings. Do you know all the black box warnings for Viberzi? It is owned by Allergan and despite all the actual horrible side effects that really do occur, it is very successful lol. Why is that do you think? Lunches, attractive people, favors for friends, lunches, and the name Allergan also helps too. Black box warnings don't really have the "Oh my god!" Effect people think it does. Ironically, the FDA has not received any complaints about negative side effects from Afrezza and there are no known hospitalizations associated with it. The problem arrises with the fact that Technosphere can be utilized for and with nearly anything. It is interesting to read all of Sealantis' international patents (AMIT spinout that Avi Kerbs and David Hankin are BoD of. Hankin is also CEO of AMF). Technosphere can be utilized in far more advanced ways than an inhaler. Don't be suprised when you see it utilized within a biodegradable fibrous mesh in conjunction with 3D printing. People want to be quick and say everything is irrelevent blah blah blah. Those same people don't read the patents and latest info from all the Al Mann related companies and MannKind partners. Type in technosphere into wipo search and take a look at all the non-mannkind affiliated companies that are using not only technosphere in their parent descriptions, but even specifically mentioning dreamboat and the cricket!! Mango, I don't always agree with your point of view, but your posts always make me think...a good thing. I do object to your comments that have nothing to do with Afrezza -- "Do you know all the black box warnings for Viberzi?" I get your point, but therapeutic options for IBS-D are limited. Yes, I believe Afrezza's short and long term health impact is superior to injectables, but it is clear that I/(we?) suspended disbelief that the system would change it's behavior overnight. Re: " Ironically, the FDA has not received any complaints about negative side effects from Afrezza and there are no known hospitalizations associated with it." Your source? Please stick to relevant/factual commentary and stay out of the rabbit holes. Enjoy a safe holiday.
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Post by derek2 on Dec 31, 2016 11:53:47 GMT -5
The replies in this thread do not answer the posted question "Why isn't the script count growing?" They address a secondary question: "Why are there not more new patients being added?" The answer to the posted question is this: Script count is not growing because patients are not sticking with Afrezza. For every new user, one discontinues. Until MNKD addresses THAT question, no amount of new users will be helpful if they just discontinue. Once somebody is using Afrezza (after going through the spirometry and possibly pre-authorization) does the black box warning make them stop? No Would coughing fits make them stop? Maybe Would trial design that showed non-inferiority and showed 37% got to treatment goal make them stop? No Would not getting to treatment goal make them stop? Maybe Add in the cost associated if 1: Copay is high, 2: Coverage is denied or 3: Patient requires more doses than are covered by insurance and you have a few reasons why patients may discontinue use. If MNKD had retained even 70% of new patients, we would be seeing thousands of weekly prescriptions even at these low weekly new Rx numbers. Pouring water into a sieve is not effective no matter how wide open you set the tap. MNKD needs to properly address retention regardless of past mistakes, past trials or current label. It is the priority. Oh, and : Happy new year!
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Post by mango on Dec 31, 2016 12:01:30 GMT -5
Any physician with common sense would know that it would take far far far more cash than what a one man funded company can afford to do all the trials required to NOT have those black box warnings. Al Mann couldn't afford to pay for every single study arm to prevent that, so they did what they could afford beyond what would be required. Had Mann had an extra 10 billion laying around maybe they could have done all those other study arms to prevent those required warning. It is seriously not an issue to have those warnings. Do you know all the black box warnings for Viberzi? It is owned by Allergan and despite all the actual horrible side effects that really do occur, it is very successful lol. Why is that do you think? Lunches, attractive people, favors for friends, lunches, and the name Allergan also helps too. Black box warnings don't really have the "Oh my god!" Effect people think it does. Ironically, the FDA has not received any complaints about negative side effects from Afrezza and there are no known hospitalizations associated with it. The problem arrises with the fact that Technosphere can be utilized for and with nearly anything. It is interesting to read all of Sealantis' international patents (AMIT spinout that Avi Kerbs and David Hankin are BoD of. Hankin is also CEO of AMF). Technosphere can be utilized in far more advanced ways than an inhaler. Don't be suprised when you see it utilized within a biodegradable fibrous mesh in conjunction with 3D printing. People want to be quick and say everything is irrelevent blah blah blah. Those same people don't read the patents and latest info from all the Al Mann related companies and MannKind partners. Type in technosphere into wipo search and take a look at all the non-mannkind affiliated companies that are using not only technosphere in their parent descriptions, but even specifically mentioning dreamboat and the cricket!! Mango, I don't always agree with your point of view, but your posts always make me think...a good thing. I do object to your comments that have nothing to do with Afrezza -- "Do you know all the black box warnings for Viberzi?" I get your point, but therapeutic options for IBS-D are limited. Yes, I believe Afrezza's short and long term health impact is superior to injectables, but it is clear that I/(we?) suspended disbelief that the system would change it's behavior overnight. Re: " Ironically, the FDA has not received any complaints about negative side effects from Afrezza and there are no known hospitalizations associated with it." Your source? Please stick to relevant/factual commentary and stay out of the rabbit holes. Enjoy a safe holiday. I was just using Viberzi as an example I realize it is not relevant to diabetes but case in point black box warnings really are not the barrier to making an informed decision. My source to the FDA and hospitalization claim is an empty search result when looking for one.
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Post by mikesmilitaria on Dec 31, 2016 12:29:51 GMT -5
In the JP Morgan Conference slides MannKind mentions the diabetes care clinics multiple times and I get the sense that it will be THEM that actually spearhead physician awareness and increase the script counts. The slides state that the clinics will be centered around Afrezza and this would be a more personalized/hands on approach for helping patients with diabetes manage their condition. Correct me if I am wrong, but even The Endo Society does not even advocate diabetes drug innovation. How many studies on Afrezza or peer reviewed papers on Afrezza have they published in their journals and/or provide the literature to Endos and actually encourage new approaches and innovations for diabetics? Bottom line is, a lot of doctors just don't want to fool with it, but they have no problem prescribing inhalers that don't even work and or outdated for COPD and asthma patients. I see diabetics in the hospital all the time because they are non-compliant, regimen is too comllicated, med is too expensive, all of it is too much to keep up with etc. Patients are for the most part lazy across the board. Afrezza and Technosphere was designed to solve non-compliance and laziness and the hurdles of carb counting etc. Put your insulin in your pocket and use when needed. Face it, the current standard is a failure and simply does not work and I see it for myself as validation that it doesnt.
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Mango- you are absolutely on target. It has been so obvious that MNKD's success with Afrezza will be thru clinics = Vdex. We are lead to believe that the one clinic in CA. is the status but I believe when they make their announcements they will include a long list of clinic openings and the primary investor is not "Bill". This is why there is no concern about script count, delisting, cash flow, etc. MNKD is keeping Afrezza on life support until this launch takes place in 2017. The same applies to RLS....there is much more to RLS than "inhalable grass" (which is a part but not THE part). All this has taken lots of time...that 65/35 partnership was dissolved but not due to Afrezza's slow sales but due to a total change in direction. There is a ton of $$ on the table and Al Mann stated that he once left the table way too soon and he would NEVER, EVER do that again. Well, Al is gone but I would wager that his plan of attack for Afrezza is still alive and about ready to rock the pharma world.
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Post by sophie on Dec 31, 2016 12:41:16 GMT -5
It has been so obvious that MNKD's success with Afrezza will be thru clinics = Vdex. We are lead to believe that the one clinic in CA. is the status but I believe when they make their announcements they will include a long list of clinic openings and the primary investor is not "Bill". This is why there is no concern about script count, delisting, cash flow, etc. MNKD is keeping Afrezza on life support until this launch takes place in 2017. The same applies to RLS....there is much more to RLS than "inhalable grass" (which is a part but not THE part). All this has taken lots of time...that 65/35 partnership was dissolved but not due to Afrezza's slow sales but due to a total change in direction. There is a ton of $$ on the table and Al Mann stated that he once left the table way too soon and he would NEVER, EVER do that again. Well, Al is gone but I would wager that his plan of attack for Afrezza is still alive and about ready to rock the pharma world. Bubble buster pessimist reporting in. Didn't VDEX open its doors sometime in October? For sure by November if not. How much has the script count gone up in those nearly 2 months when it has been apparent that prescribing afrezza was the #1 priority? It's most likely due to low volume at the clinic, but we don't have unlimited time for this to take off. Additional financing at this point will be difficult to get, although reducing debt was helpful. I don't think we have several years to rely on clinics to be our savior.
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Post by sportsrancho on Dec 31, 2016 13:00:43 GMT -5
mannmade Global Moderator Dec 1, 2016 at 4:28pm liane, nemzter, and 12 more like this Quote Vdex has officially opened for business in their first location where they officially began seeing patients today. Spread the word... please see below for the Vdex phone numbers: VDEX #:818-661-6367 and 866-4glucose Read more: mnkd.proboards.com/thread/6681/vdex-question#ixzz4URJqrbWi
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Post by sportsrancho on Dec 31, 2016 13:04:18 GMT -5
#1....It's hasn't even been a month! #2....There is one. And I hope they do so well that they will be able to open more! #3...Bill is the owner. Don't read anymore into it,
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Post by mannmade on Dec 31, 2016 13:08:11 GMT -5
Exactly as Sports states... They are building a business from the ground up. They are taking the initiative to do something.... They are part of the solution NOT the solution... as many might hope for... AND "hope is not a strategy..."
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