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Post by seanismorris on Mar 10, 2017 22:54:44 GMT -5
It's been 6 month + (June 2016) since MannKind announced "research and clinical trial" collaboration with JDFR.
A search of clinicaltrials.gov shows ZERO results. No studies open, none recruiting...
My hope was we were getting closer to results. Is it reasonable to expect nothing this year?
I originally thought 6 months from the announcement we'd see something. Did anyone else get the same impression from management?
Was the original announcement just "fluff"? We need a whole lot of clarity, for a whole lot of things, on this call.
---- I'm still checking new/updated patents regularly. Nothing since 12/1/2016. I think the time between patents is a new record...
Another day goes by. Another day not happy with MannKind. They are the do nothing company... everything they say is "fluff" at this point.
Announcing a commercial or show sponsorship (at some distant date) is fluff.
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Post by mango on Mar 11, 2017 2:21:00 GMT -5
It's been 6 month + (June 2016) since MannKind announced "research and clinical trial" collaboration with JDFR. A search of clinicaltrials.gov shows ZERO results. No studies open, none recruiting... My hope was we were getting closer to results. Is it reasonable to expect nothing this year? I originally thought 6 months from the announcement we'd see something. Did anyone else get the same impression from management? Was the original announcement just "fluff"? We need a whole lot of clarity, for a whole lot of things, on this call. ---- I'm still checking new/updated patents regularly. Nothing since 12/1/2016. I think the time between patents is a new record...Another day goes by. Another day not happy with MannKind. They are the do nothing company... everything they say is "fluff" at this point. Announcing a commercial or show sponsorship (at some distant date) is fluff. IRE-1α inhibitorsType: Grant Filed: December 15, 2015 Date of Patent: January 17, 2017Assignee: MannKind Corporation Inventors: John B. Patterson, David G. Lonergan, Gary A. Flynn, Qingpeng Zeng, Peter V. Pallai patents.justia.com/patent/9546149DRY POWDER INHALER AND DRUG DELIVERY SYSTEMApplication Date: December 6, 2009 Publication Date: January 18, 2017Inventors: ...MANN Alfred (US) patentscope.wipo.int/search/en/detail.jsf?docId=RU192211356&recNum=6&maxRec=1270&office=&prevFilter=&sortOption=Pub+Date+Desc&queryString=ALL%3A%28MannKind%29&tab=NationalBiblioA DRY POWDER INHALATION SYSTEMApplication Date: March 27, 2009 Publication Date: January 27, 2017Applicants: MANNKIND CORPORATION Inventors: SMUTNEY, CHAD, C. KINSEY, P. Spencer POLIDORO, JOHN, M. SAHI, CARL, R. ADAMO, Benoit MCLEAN, SCOTT, OVERFIELD, DENNIS BRYANT, ANTHONY patentscope.wipo.int/search/en/detail.jsf?docId=SG192215789&recNum=4&office=&queryString=ALL%3A%28MannKind%29&prevFilter=&sortOption=Pub+Date+Desc&maxRec=1270Apparatus and method for cryogranulating a pharmaceutical compositionType: Grant Filed: October 29, 2013 Date of Patent: February 14, 2017Assignee: MannKind Corporation Inventors: Edwin Amoro, Karel Vanackere, Michael A. White patents.justia.com/patent/9566243IRE-1A InhibitorsApplication Date: June 9, 2008 Publication Date: February 16, 2017Applicants: MannKind Corporation Inventors: PATTERSON, John, Bruce LONERGAN, David, Gregory FLYNN, Gary A. ZHENG, Qingping PALLAI, Peter V. patentscope.wipo.int/search/en/detail.jsf?docId=ES192392877&recNum=3&office=&queryString=ALL%3A%28MannKind%29&prevFilter=&sortOption=Pub+Date+Desc&maxRec=1270Composition, method of synthesizing fumaryl diketopiperazine microparticles, method of delivering insulin to a patient in need thereof, and diketopiperazine microparticleApplication Date: June 18, 2012 Publication Date: February 21, 2017Applicants: MANNKIND CORPORATION Inventors: GRAYSON W. STOWELL MARSHALL GRANT PAUL MENKIN patentscope.wipo.int/search/en/detail.jsf?docId=BR192391054&recNum=2&office=&queryString=ALL%3A%28MannKind%29&prevFilter=&sortOption=Pub+Date+Desc&maxRec=1270
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Post by matt on Mar 11, 2017 8:34:42 GMT -5
Depending on the number of hospitals involved, it can easily take more than six months to develop a consensus protocol acceptable to all investigators and get it approved by the respective institutional review boards and the FDA. Some of the IRBs are worse to deal with than FDA. Remember that the investigators have to read and suggest changes to the protocol in addition to their "regular" jobs teaching or seeing patients, and that some IRBs only meet once a month. If you have to go through two or three loops with the IRBs, who may or may not agree on certain matters, that can really slow things down.
While so people have said differently, the FDA does impose a requirement to test any new drug on a pediatric population if the drug could potentially apply to that age group. There is no need to conduct pediatric tests on drugs for diseases of old age, but insulin is not one of those. I don't know the current policy of FDA, but in Europe if the sponsor fails to conduct the pediatric trial within the agreed time frame then the agency can pull the adult drug from the market. You don't know what parameters FDA is insisting on for this trial, and all of it takes time to negotiate as it is an iterative process involving the investigators, FDA, and IRBs.
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Post by peppy on Mar 11, 2017 8:58:38 GMT -5
Depending on the number of hospitals involved, it can easily take more than six months to develop a consensus protocol acceptable to all investigators and get it approved by the respective institutional review boards and the FDA. Some of the IRBs are worse to deal with than FDA. Remember that the investigators have to read and suggest changes to the protocol in addition to their "regular" jobs teaching or seeing patients, and that some IRBs only meet once a month. If you have to go through two or three loops with the IRBs, who may or may not agree on certain matters, that can really slow things down. While so people have said differently, the FDA does impose a requirement to test any new drug on a pediatric population if the drug could potentially apply to that age group. There is no need to conduct pediatric tests on drugs for diseases of old age, but insulin is not one of those. I don't know the current policy of FDA, but in Europe if the sponsor fails to conduct the pediatric trial within the agreed time frame then the agency can pull the adult drug from the market. You don't know what parameters FDA is insisting on for this trial, and all of it takes time to negotiate as it is an iterative process involving the investigators, FDA, and IRBs. At one point under sanofi, the pediatric trail information online said recruiting. The recruitment was suspended. www.clinicaltrials.gov/ct2/show/NCT02527265?term=diabetes&lup_s=08/04/2015&lup_d=14&show_rss=Y&sel_rss=mod14
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Post by nadathing on Mar 11, 2017 13:26:11 GMT -5
Every week when I see the script numbers it tells me that SNY was right. Afrezza is not commercially viable in the USA for adults. I just don't see it happening for years, if ever. People are not refilling scripts because it is not working for them. I don't accept the excuse that it is the cost. I check pricing on meds BEFORE I get a script filled. I wouldn't even bother starting on a med I knew I couldn't afford. Is it titration? Could be, but MNKD has had 3 years to work on dosing issues with no success.
The market is juvenile diabetes. Where are the studies for that market? Why aren't they completed? Were they even started? Who knows. All I know is that we are on life support and so far behind where we should be at this time that I don't see a future for MNKD through the end of the year.
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Post by dg1111 on Mar 11, 2017 13:49:40 GMT -5
I would expect that at one or both of the conference calls this week we will hear about the status of the pediatric study, the study to improve the label, and the epi-sphere trials that were supposed to start this quarter.
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Post by dreamboatcruise on Mar 11, 2017 16:17:55 GMT -5
I would expect that at one or both of the conference calls this week we will hear about the status of the pediatric study, the study to improve the label, and the epi-sphere trials that were supposed to start this quarter. Big question is whether the status will have changed any.
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Post by dreamboatcruise on Mar 11, 2017 16:22:46 GMT -5
Every week when I see the script numbers it tells me that SNY was right. Afrezza is not commercially viable in the USA for adults. I just don't see it happening for years, if ever. People are not refilling scripts because it is not working for them. I don't accept the excuse that it is the cost. I check pricing on meds BEFORE I get a script filled. I wouldn't even bother starting on a med I knew I couldn't afford. Is it titration? Could be, but MNKD has had 3 years to work on dosing issues with no success. The market is juvenile diabetes. Where are the studies for that market? Why aren't they completed? Were they even started? Who knows. All I know is that we are on life support and so far behind where we should be at this time that I don't see a future for MNKD through the end of the year. If your first thesis is correct, and I don't agree, I'd question your second one. If there is some insurmountable obstacle to adoption for adults, I don't think pediatrics is going to be a savior.
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Post by peppy on Mar 11, 2017 20:48:27 GMT -5
Every week when I see the script numbers it tells me that SNY was right. Afrezza is not commercially viable in the USA for adults. I just don't see it happening for years, if ever. People are not refilling scripts because it is not working for them. I don't accept the excuse that it is the cost. I check pricing on meds BEFORE I get a script filled. I wouldn't even bother starting on a med I knew I couldn't afford. Is it titration? Could be, but MNKD has had 3 years to work on dosing issues with no success. The market is juvenile diabetes. Where are the studies for that market? Why aren't they completed? Were they even started? Who knows. All I know is that we are on life support and so far behind where we should be at this time that I don't see a future for MNKD through the end of the year. And yet some people with continuous glucose monitors talk about how well afrezza works for them. Sam, Eric, Lauren, Laura K. Damon, Matt B, Dr Edelman, etc. Afrezza seems to be working for some people. They really like it. Dr. Edelman, TCOYD and Afrezza www.youtube.com/watch?v=Ih3ZaRjtPOs&t=6s
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Post by agedhippie on Mar 11, 2017 22:17:44 GMT -5
Every week when I see the script numbers it tells me that SNY was right. Afrezza is not commercially viable in the USA for adults. I just don't see it happening for years, if ever. People are not refilling scripts because it is not working for them. I don't accept the excuse that it is the cost. I check pricing on meds BEFORE I get a script filled. I wouldn't even bother starting on a med I knew I couldn't afford. Is it titration? Could be, but MNKD has had 3 years to work on dosing issues with no success. The market is juvenile diabetes. Where are the studies for that market? Why aren't they completed? Were they even started? Who knows. All I know is that we are on life support and so far behind where we should be at this time that I don't see a future for MNKD through the end of the year. And yet some people with continuous glucose monitors talk about how well afrezza works for them. Sam, Eric, Lauren, Laura K. Damon, Matt B, Dr Edelman, etc. Afrezza seems to be working for some people. They really like it. Dr. Edelman, TCOYD and Afrezza www.youtube.com/watch?v=Ih3ZaRjtPOs&t=6s
The people you list all undoubtedly did well, but presumably given the repeat prescription sizes there is a far longer list of people where it didn't work, or they gave up, or they just preferred injections. The early adopters are important to show that Afrezza can have excellent results, the trials are important to see if those results are typical in the wider community where people are not as conscientious or motivated. That is the issue for endos - to date the trial data says no.
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Post by peppy on Mar 11, 2017 22:27:27 GMT -5
And yet some people with continuous glucose monitors talk about how well afrezza works for them. Sam, Eric, Lauren, Laura K. Damon, Matt B, Dr Edelman, etc. Afrezza seems to be working for some people. They really like it. Dr. Edelman, TCOYD and Afrezza www.youtube.com/watch?v=Ih3ZaRjtPOs&t=6s
The people you list all undoubtedly did well, but presumably given the repeat prescription sizes there is a far longer list of people where it didn't work, or they gave up, or they just preferred injections. The early adopters are important to show that Afrezza can have excellent results, the trials are important to see if those results are typical in the wider community where people are not as conscientious or motivated. That is the issue for endos - to date the trial data says no. I do not buy that the people that went off afrezza preferred shots. I do buy the physicians probably give then a 30 day pack of 4 unit cartridges, and they did not receive enough insulin.
I believe you buy the story because you inject, your physician will not allow you to try afrezza, and you want to be correct.
The only person on the board that states they prefer shots is nada thing and he is type two, so he has choices you do not have. we all know his choice.
Does not matter what I buy though. I am not type one diabetic.
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Post by sayhey24 on Mar 12, 2017 7:32:12 GMT -5
The people you list all undoubtedly did well, but presumably given the repeat prescription sizes there is a far longer list of people where it didn't work, or they gave up, or they just preferred injections. The early adopters are important to show that Afrezza can have excellent results, the trials are important to see if those results are typical in the wider community where people are not as conscientious or motivated. That is the issue for endos - to date the trial data says no. I do not buy that the people that went off afrezza preferred shots. I do buy the physicians probably give then a 30 day pack of 4 unit cartridges, and they did not receive enough insulin.
I believe you buy the story because you inject, your physician will not allow you to try afrezza, and you want to be correct.
The only person on the board that states they prefer shots is nada thing and he is type two, so he has choices you do not have. we all know his choice.
Does not matter what I buy though. I am not type one diabetic.
The answer I get back about why prescriptions are not being refilled after the spirometer, insurance mess is three fold. First is 90 cartridges will not get someone through a month if they are using two for some meals. If they get a 3 month prescription they run out within 2 months. Second, that leads to the product being to expensive. Third, that leads to frustration because most of the PWDs using are not using CGMs so they do not see the immediate time in range results. What happens is they have to go back on their RAA, get frustrated, and go back to the doctor who gave it a try.. Another issue which MNKD needs to figure out is refrigeration and the pharmacies. The afrezza boxes take up a lot of space in the refrigerator. The stuff really does not need short term refrigeration. That is not what the label says so they need to address. Thats the best analysis I have come up with and I ask everyone I can as to what the issue is. Any other inputs I would appreciate. To even suggest the exact same insulin which is released by the pancreas does not work is ludicrous. There are many cases where it is under dosed which needs to be fixed but when properly dosed nothing works better.
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Post by sportsrancho on Mar 12, 2017 8:32:33 GMT -5
Tom's scripts for his kids are good for a year. Do people get 3 month scripts?
He buys Afrezza every 3 months. His daughter just renewed her script and Health Net just up and denied it. He's never had any trouble with them before and pays around $60 per month for each child.
Being a very long MNKD long... he taught them how to dose. No problems there:-) He's being trying for weeks now to get the 8 and 12 packs and CVS says they can't get them. They said they had 8 boxes but they were on hold for other people. WTH?
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Post by derek2 on Mar 12, 2017 8:43:55 GMT -5
I do not buy that the people that went off afrezza preferred shots. I do buy the physicians probably give then a 30 day pack of 4 unit cartridges, and they did not receive enough insulin.
I believe you buy the story because you inject, your physician will not allow you to try afrezza, and you want to be correct.
The only person on the board that states they prefer shots is nada thing and he is type two, so he has choices you do not have. we all know his choice.
Does not matter what I buy though. I am not type one diabetic.
The answer I get back about why prescriptions are not being refilled after the spirometer, insurance mess is three fold. First is 90 cartridges will not get someone through a month if they are using two for some meals. If they get a 3 month prescription they run out within 2 months. Second, that leads to the product being to expensive. Third, that leads to frustration because most of the PWDs using are not using CGMs so they do not see the immediate time in range results. What happens is they have to go back on their RAA, get frustrated, and go back to the doctor who gave it a try.. Another issue which MNKD needs to figure out is refrigeration and the pharmacies. The afrezza boxes take up a lot of space in the refrigerator. The stuff really does not need short term refrigeration. That is not what the label says so they need to address. Thats the best analysis I have come up with and I ask everyone I can as to what the issue is. Any other inputs I would appreciate. To even suggest the exact same insulin which is released by the pancreas does not work is ludicrous. There are many cases where it is under dosed which needs to be fixed but when properly dosed nothing works better. Mike C.agrees with both you and Peppy: But back to the topic of the thread: Mannkind has completed a handling study for the Dreamboat (Gen 2) inhaler. It used no insulin r Technosphere. It showed that children as young as 4 years old could be taught to handle and use the inhaler correctly. Mannkind owes the FDA a 2-part study: As for timeline: As with all things MNKD, it's less risky to rely on what they've attested to as opposed to what they say under the protection of safe harbor statements.
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Post by peppy on Mar 12, 2017 9:04:51 GMT -5
Tom's scripts for his kids are good for a year. Do people get 3 month scripts? He buys Afrezza every 3 months. His daughter just renewed her script and Health Net just up and denied it. He's never had any trouble with them before and pays around $60 per month for each child. Being a very long MNKD long... he taught them how to dose. No problems there:-) He's being trying for weeks now to get the 8 and 12 packs and CVS says they can't get them. They said they had 8 boxes but they were on hold for other people. WTH? Quote: His daughter just renewed her script and Health Net just up and denied it.
Reply: How often is this happening? Is this part of the refill problem?
Sports, why doesn't tom try and get the titration pack? New prescription difficult to obtain?
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