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Post by rockstarrick on Mar 12, 2017 23:43:20 GMT -5
So... are we in agreement that without new data there won't be a Label change or it won't be a significant change? MannKind could argue that the Label is to stringent. But it's not. The only thing that could change would be approved for Pediatric use. (Needs a Trial) MannKind could argue that Afrezza is Ultra, but the FDA is unlikely to create a drug category for one poorly performing drug ($$$ wise). I look at a drug Label as similar to a legal precedence. It's not going to get changed easily... The lung cancer risk, and reduced lung function is the major deterrent on the Label. The FDA has asked for a follow up study, that MannKind hasn't even started yet. So, nothing is going to change there. The only other thing I can think of that could change is the recommended time for taking Afrezza. In other words, taking it immediately before eating rather than 15 minutes. To be clear I very very much want Afrezza approved for Pediatric use! ----- The biggest problem (for success) I see is getting Doctors to agree that patents need to figure out their own dosing. And, Doctors are just there to advise them (which is where the sales people come in)... I think Doctors HATE telling that to their patients. To get a really tight, optimal range, with Afrezza it's on the patients. I'm not saying the situation isn't going to approve, but it's most likely going to result from better coverage and creating patient awareness. Docs may get on board after seeing Afrezza really does work. But until then we're fight an entrenched status quo. MARKETING, MARKETING, MARKETING MannKind, just do it! (you procrastinating assholes) I think the changes we will see to the label will be correction type changes rather than improvement type changes like superiority or ultra fast for example. There are parts of our label that are just wrong, like when to inhale afrezza, if you follow the label, afrezza will be peaking about the time you start eating, I wouldn't think a correction like this would require a clinical trial. If enough PWD and Healthcare Providers complain in writing to the FDA that they have substantially better results when waiting until they start eating to inhale, rather than following the instructions on the label the FDA could allow a change without a formal clinical trial. There has to be a little flexibility for changes, every change can't require a trial, right ??
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Post by seanismorris on Mar 13, 2017 0:22:14 GMT -5
Yes. The timing of taking the drug should be able to be updated. / no trail
That was one of the weird things about the old trials.
When? Should have been one of the first things MannKind nailed down. They might have shown superiority if they did it right in the original trials/submission...
I get that dosage is variable, but timing should have been pretty much universal. Afrezza's claim to fame is it's PK so the fact that it needs to be updated/fixed is baffling. They had 10 years...
---- If the timing is what MannKind is talking about when they suggested the Label would be updated (this year) that would be disappointing. I think they're already telling docs that the 15min. isn't ideal.
If they do need data to make the update they probably could do an analysis of the old trials... but using new Pediatric data would be easier.
It's probably obvious that I'm pushing for the Pediatric Trial. My patience is worn past thin. When they say they're going to do something they should do it. Their argument for the delay is probably to save money. Which is BS (if it is) burning cash with delays is worse.
As far as I can tell, the company hasn't done a single thing since the last call. No sponsoring a show (if the future) doesn't count. Neither does selling a property to raise cash. The only thing that counts is rising scripts.
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Post by rockstarrick on Mar 13, 2017 1:07:52 GMT -5
Yes. The timing of taking the drug should be able to be updated. / no trail That was one of the weird things about the old trials. When? Should have been one of the first things MannKind nailed down. They might have shown superiority if they did it right in the original trials/submission... I get that dosage is variable, but timing should have been pretty much universal. Afrezza's claim to fame is it's PK so the fact that it needs to be updated/fixed is baffling. They had 10 years... ---- If the timing is what MannKind is talking about when they suggested the Label would be updated (this year) that would be disappointing. I think they're already telling docs that the 15min. isn't ideal. If they do need data to make the update they probably could do an analysis of the old trials... but using new Pediatric data would be easier. It's probably obvious that I'm pushing for the Pediatric Trial. My patience is worn past thin. When they say they're going to do something they should do it. Their argument for the delay is probably to save money. Which is BS (if it is) burning cash with delays is worse. As far as I can tell, the company hasn't done a single thing since the last call. No sponsoring a show (if the future) doesn't count. Neither does selling a property to raise cash. The only thing that counts is rising scripts. I believe they are required to get it done by a date determined by the FDA, money or no money. If they fail to meet the deadline, I believe they can stop sales to adult patients, not 100% sure on this but I did read it somewhere. Maybe there is a way to find out what the timeframe is for pediatric studies for drugs that both adults and children can take.
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Post by rockstarrick on Mar 13, 2017 1:16:54 GMT -5
Yes. The timing of taking the drug should be able to be updated. / no trail That was one of the weird things about the old trials. When? Should have been one of the first things MannKind nailed down. They might have shown superiority if they did it right in the original trials/submission... I get that dosage is variable, but timing should have been pretty much universal. Afrezza's claim to fame is it's PK so the fact that it needs to be updated/fixed is baffling. They had 10 years... ---- If the timing is what MannKind is talking about when they suggested the Label would be updated (this year) that would be disappointing. I think they're already telling docs that the 15min. isn't ideal. If they do need data to make the update they probably could do an analysis of the old trials... but using new Pediatric data would be easier. It's probably obvious that I'm pushing for the Pediatric Trial. My patience is worn past thin. When they say they're going to do something they should do it. Their argument for the delay is probably to save money. Which is BS (if it is) burning cash with delays is worse. As far as I can tell, the company hasn't done a single thing since the last call. No sponsoring a show (if the future) doesn't count. Neither does selling a property to raise cash. The only thing that counts is rising scripts. I believe they are required to get it done by a date determined by the FDA, money or no money. If they fail to meet the deadline, I believe they can stop sales to adult patients, not 100% sure on this but I did read it somewhere. Maybe there is a way to find out what the timeframe is for pediatric studies for drugs that both adults and children can take. A quick search and I found this. www.fda.gov/downloads/ScienceResearch/SpecialTopics/PediatricTherapeuticsResearch/UCM262309.pdfI don't know if there's anything useful to us but I is interesting.
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Post by rockstarrick on Mar 13, 2017 1:39:41 GMT -5
I believe they are required to get it done by a date determined by the FDA, money or no money. If they fail to meet the deadline, I believe they can stop sales to adult patients, not 100% sure on this but I did read it somewhere. Maybe there is a way to find out what the timeframe is for pediatric studies for drugs that both adults and children can take. A quick search and I found this. www.fda.gov/downloads/ScienceResearch/SpecialTopics/PediatricTherapeuticsResearch/UCM262309.pdfI don't know if there's anything useful to us but I is interesting. There are waivers to some pediatric studies, – If the course of the disease and the effects of the drug are sufficiently similar in adult and pediatric patients, FDA may conclude that pediatric efficacy can be extrapolated from adequate and well- controlled studies in adults, usually supplemented with other information obtained in pediatric patients, such as pharmacokinetic studies. I think there is a lot of good information in the link I shared regarding pediatric studies.
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Post by rockstarrick on Mar 13, 2017 1:54:02 GMT -5
There are waivers to some pediatric studies, – If the course of the disease and the effects of the drug are sufficiently similar in adult and pediatric patients, FDA may conclude that pediatric efficacy can be extrapolated from adequate and well- controlled studies in adults, usually supplemented with other information obtained in pediatric patients, such as pharmacokinetic studies. I think there is a lot of good information in the link I shared regarding pediatric studies. This is the actual Federal Regulation and it also talks about waivers, so there very well could be talks with the FDA happening in regards to pediatric studies without a trial listed. I'm not suggesting there is anything, but I am suggesting there could be. Read it www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.55
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Post by sportsrancho on Mar 13, 2017 5:45:16 GMT -5
There are waivers to some pediatric studies, – If the course of the disease and the effects of the drug are sufficiently similar in adult and pediatric patients, FDA may conclude that pediatric efficacy can be extrapolated from adequate and well- controlled studies in adults, usually supplemented with other information obtained in pediatric patients, such as pharmacokinetic studies. I think there is a lot of good information in the link I shared regarding pediatric studies. This is the actual Federal Regulation and it also talks about waivers, so there very well could be talks with the FDA happening in regards to pediatric studies without a trial listed. I'm not suggesting there is anything, but I am suggesting there could be. Read it www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.55 That was a great find! Fingers crossed.
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Post by factspls88 on Mar 13, 2017 9:11:57 GMT -5
So... are we in agreement that without new data there won't be a Label change or it won't be a significant change? MannKind could argue that the Label is to stringent. But it's not. The only thing that could change would be approved for Pediatric use. (Needs a Trial) MannKind could argue that Afrezza is Ultra, but the FDA is unlikely to create a drug category for one poorly performing drug ($$$ wise). I look at a drug Label as similar to a legal precedence. It's not going to get changed easily... The lung cancer risk, and reduced lung function is the major deterrent on the Label. The FDA has asked for a follow up study, that MannKind hasn't even started yet. So, nothing is going to change there. The only other thing I can think of that could change is the recommended time for taking Afrezza. In other words, taking it immediately before eating rather than 15 minutes. To be clear I very very much want Afrezza approved for Pediatric use! ----- The biggest problem (for success) I see is getting Doctors to agree that patents need to figure out their own dosing. And, Doctors are just there to advise them (which is where the sales people come in)... I think Doctors HATE telling that to their patients. To get a really tight, optimal range, with Afrezza it's on the patients. I'm not saying the situation isn't going to approve, but it's most likely going to result from better coverage and creating patient awareness. Docs may get on board after seeing Afrezza really does work. But until then we're fight an entrenched status quo. MARKETING, MARKETING, MARKETING MannKind, just do it! (you procrastinating assholes) If I am remembering correctly, Mannkind has submitted data to the FDA to change the label and is not expecting to get a decision until September. The focus was on rapid action and reduced risk of hypos if I am not mistaken.
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Post by surplusvalue on Mar 13, 2017 10:49:32 GMT -5
In full agreement with seanismorris and rockstarrick that the present label indication of timing (when to take Afrezza) is a huge problem and needs to change immediately. Its been a huge problem for a long time. The problems with titration and dosing and in turn retention, which MNKD has stated are significant impediments to success can be linked back to this if the patients are taking it too soon. The result will be ..its not working well and we all know how that has panned out. As I said in previous posts this is the sort of thing that MNKD should have been on top of from the beginning in seeking a change to the instructions for usage. They have spent too much of their effort banging their heads against the wall trying to "educate" the doctors with no marketing and no patient awareness as well.
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Post by peppy on Mar 13, 2017 10:51:40 GMT -5
In full agreement with seanismorris and rockstarrick that the present label indication of timing (when to take Afrezza) is a huge problem and needs to change immediately. Its been a huge problem for a long time. The problems with titration and dosing and in turn retention, which MNKD has stated are significant impediments to success can be linked back to this if the patients are taking it too soon. The result will be ..its not working well and we all know how that has panned out. As I said in previous posts this is the sort of thing that MNKD should have been on t,op of from the beginning in seeking a change to the instructions for usage. They have spent too much of their effort banging their heads against the wall trying to "educate" the doctors with no marketing and no patient awareness. And yet the insulin analog dosing has been figured out. Becareful, that stuff will kill you!
www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s115lbl.pdf www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s082lbl.pdf www.accessdata.fda.gov/drugsatfda_docs/label/2008/021629s015lbl.pdf
• Hypoglycemia: Most common adverse reaction of insulin therapy and may be life-threatening (5.2) • Hypokalemia: All insulins, including APIDRA can cause hypokalemia, which if untreated, may result in respiratory paralysis, ventricular arrhythmia, and death (5.4) • Renal or hepatic impairment: Like all insulins, may require a reduction in the APIDRA dose (5.5)
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Post by surplusvalue on Mar 13, 2017 11:03:45 GMT -5
In full agreement with seanismorris and rockstarrick that the present label indication of timing (when to take Afrezza) is a huge problem and needs to change immediately. Its been a huge problem for a long time. The problems with titration and dosing and in turn retention, which MNKD has stated are significant impediments to success can be linked back to this if the patients are taking it too soon. The result will be ..its not working well and we all know how that has panned out. As I said in previous posts this is the sort of thing that MNKD should have been on t,op of from the beginning in seeking a change to the instructions for usage. They have spent too much of their effort banging their heads against the wall trying to "educate" the doctors with no marketing and no patient awareness. And yet the insulin analog dosing has been figured out. Becareful, that stuff will kill you!
Yes well. The real kicker here is that MNKD has spent all this time educating the doctors, if they were instructing according to the label guidelines, incorrectly. Now if they get a change in label they have to go back and say that what we told you before was incorrect as to when patients should take Afrezza. Can you imagine the reaction..."these people dont know what they are doing with their own product". MNKD has a habit of not setting proper priorities and doing things ass backwards. This should have been a priority as soon as they got the NDA back from Sanofi. Instead they spent all this time, cash burn and effort reinforcing a counterproductive use of the product.
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Post by peppy on Mar 13, 2017 11:08:49 GMT -5
Afrezza: broncho spasm or Fast acting analogs: heart attack (hypokalemia) is what the labels say.
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Post by agedhippie on Mar 13, 2017 11:34:27 GMT -5
Afrezza: broncho spasm or Fast acting analogs: heart attack (hypokalemia) is what the labels say. Afrezza should have those warnings as well because they are insulin related. Hypokalemia is a good example; it is part of the electrolyte imbalance caused by DKA rather than insulin as such. So it's cause by the omission of insulin rather than insulin itself.
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Post by peppy on Mar 13, 2017 12:27:16 GMT -5
Afrezza: broncho spasm or Fast acting analogs: heart attack (hypokalemia) is what the labels say. Afrezza should have those warnings as well because they are insulin related. Hypokalemia is a good example; it is part of the electrolyte imbalance caused by DKA rather than insulin as such. So it's cause by the omission of insulin rather than insulin itself. afrezza: • Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. (5.8)
Apidra: • Hypokalemia: All insulins, including APIDRA can cause hypokalemia, which if untreated, may result in respiratory paralysis, ventricular arrhythmia, and death (5.4)
www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf www.accessdata.fda.gov/drugsatfda_docs/label/2008/021629s015lbl.pdf
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Post by rockstarrick on Mar 13, 2017 14:32:11 GMT -5
In full agreement with seanismorris and rockstarrick that the present label indication of timing (when to take Afrezza) is a huge problem and needs to change immediately. Its been a huge problem for a long time. The problems with titration and dosing and in turn retention, which MNKD has stated are significant impediments to success can be linked back to this if the patients are taking it too soon. The result will be ..its not working well and we all know how that has panned out. As I said in previous posts this is the sort of thing that MNKD should have been on top of from the beginning in seeking a change to the instructions for usage. They have spent too much of their effort banging their heads against the wall trying to "educate" the doctors with no marketing and no patient awareness as well. Absolutely should've been addressed in 2015 during the initial launch, (at the latest). My friend, T2, started afrezza and was taking it 20 minutes before eating because of the label, I told him he needs to take when he starts eating, and then may need a follow up depending on how fast he eats or what he eats. He couldn't get it into his head that he may need a follow up dose, wouldn't do it and wound up stopping afrezza because of an incorrect label. This is something that will take a lot of time, getting a PWD to stack insulin doses will not be easy. Mike has a lot of work to do, there are a lot of rough edges that need attention ASAP.
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