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Post by pguererro on Mar 7, 2020 18:50:30 GMT -5
Afrezza should own what we all hope is the new “gold standard” of measuring T1 and T2 diabetes. The problem is the studies (that have been approved to present to docs) have been underdosed terribly. It doesn’t move the needle to show a 10% Improvement on TIR with 50% reduction in hypo. That data came out 2 years ago. Studies need to be calibrated to have the same incidence of hypo vs RAA and THEN Mannkind will show the true benefit of Afrezza. We all have heard true life changing stories where patients go from 58% to 85% TIR. It’s on Mannkind that they haven’t set up these studies to show the true value of Afrezza. I mean who set up the protocol for patients to check BS and dose Both 1 and 2 hours after mealtime. Incompetent.
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Post by centralcoastinvestor on Mar 7, 2020 21:12:20 GMT -5
The stupid FDA is the one who set up the protocols for the trials. After the 2nd CRL, Mnkd and Al were desperate to get something approved. The FDA did not have a clue how well Afrezza worked or the mechanics on how patients should use it. So Mnkd had to settle for a very crappy approval protocol. It is a testament to how good Afrezza works that it was approved even with crap protocols.
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Post by pguererro on Mar 8, 2020 0:20:14 GMT -5
I’m not talking about the FDA approved trials that showed Novolog had a statistically significant advantage vs Afrezza. That feels like 100 years ago. Check out the new data in the last few years or don’t talk on this site about AL MANN.
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Post by mango on Mar 8, 2020 10:40:34 GMT -5
Some people are truly deranged.
But, that's just mango'stakeonit
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Post by matt on Mar 8, 2020 11:29:20 GMT -5
The stupid FDA is the one who set up the protocols for the trials. The FDA never dictates trial protocol. They do give guidance on what parameters they need to see in order for the drug to be approvable, but that is it. The sponsor is not handcuffed in any way and unless the trial poses an undue risk of harm to the patient the sponsor can include additional arms to prove whatever they like. That is with an unapproved drug; with an approved drug it becomes even easier to run trials since FDA is not generally not involved. If the trial design is bad (and some of MNKD's trials have been poorly designed) then they have nobody to blame but themselves. There are lots of ways to game the results of a trial, but most physicians can spot deficient designs a mile away (like comparing Afrezza against RAA while allowing Afrezza redosing after seeing what the CGM sales but not allowing redosing for the RAA). Anyone who has spent any time writing clinical trial protocols knows better. |
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Post by centralcoastinvestor on Mar 8, 2020 14:19:37 GMT -5
The stupid FDA is the one who set up the protocols for the trials. They do give guidance on what parameters they need to see in order for the drug to be, but that is it. The sponsor is not handcuffed in any way and unless the trial poses an undue risk of harm to the patient the sponsor can include additional arms to prove whatever they like. That is with an unapproved drug; with an approved drug it becomes even easier to run trials since FDA is not generally not involved. If the trial design is bad (and some of MNKD's trials have been poorly designed) then they have nobody to blame but themselves. There are lots of ways to game the results of a trial, but most physicians can spot deficient designs a mile away (like comparing Afrezza against RAA while allowing Afrezza redosing after seeing what the CGM sales but not allowing redosing for the RAA). Anyone who has spent any time writing clinical trial protocols knows better. Sorry but I am going to disagree with you on your first statement. If the FDA says they won’t approve the protocol that the company is suggesting then you are dead in the water. So you must follow exactly what they want or your drug doesn’t get approved. Al Mann stated that Afrezza should be taken 10 minutes after the start of a meal. The FDA would not allow that in the trial protocol because they completely did not understand how fast Afrezza worked nor how fast it left a person’s system. Prior to FDA approval, a review panel was held. The FDA reviewer was completely clueless on presenting Afrezza to the panel. So much so, that one of the experts stated that you would kill my patient if you used the product like you are proposing. The FDA has been a huge impediment to the success of Afrezza because Afrezza was completely different from what they understood with RAA. A new larger trial would help but Mnkd doesn’t have the money thanks to the stupid shorts. But the longer the company survives the greater chance it will have to be broadly accepted in diabetes world. Time will tell. |
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Post by sweedee79 on Mar 8, 2020 15:45:26 GMT -5
mnkd needs some kind of trial data for the sales reps to work with so they can sell it.. does it have to be expensive large trial data?
It sounds like Endos are way under dosing.. which from personal experience I believe to be true.
It is so frustrating.. does Mnkd not understand their own drug and what they need to do to be able to sell it?
I'm so past trying to find someone or something to blame.. what is the solution.. let's find it and do it!!!
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Post by mango on Mar 8, 2020 16:08:12 GMT -5
The FDA never dictates trial protocol. They do give guidance on what parameters they need to see in order for the drug to be, but that is it. The sponsor is not handcuffed in any way and unless the trial poses an undue risk of harm to the patient the sponsor can include additional arms to prove whatever they like. That is with an unapproved drug; with an approved drug it becomes even easier to run trials since FDA is not generally not involved. If the trial design is bad (and some of MNKD's trials have been poorly designed) then they have nobody to blame but themselves. There are lots of ways to game the results of a trial, but most physicians can spot deficient designs a mile away (like comparing Afrezza against RAA while allowing Afrezza redosing after seeing what the CGM sales but not allowing redosing for the RAA). Anyone who has spent any time writing clinical trial protocols knows better. Sorry but I am going to disagree with you on your first statement. If the FDA says they won’t approve the protocol that the company is suggesting then you are dead in the water. So you must follow exactly what they want or your drug doesn’t get approved. Al Mann stated that Afrezza should be taken 10 minutes after the start of a meal. The FDA would not allow that in the trial protocol because they completely did not understand how fast Afrezza worked nor how fast it left a person’s system. Prior to FDA approval, a review panel was held. The FDA reviewer was completely clueless on presenting Afrezza to the panel. So much so, that one of the experts stated that you would kill my patient if you used the product like you are proposing. The FDA has been a huge impediment to the success of Afrezza because Afrezza was completely different from what they understood with RAA. A new larger trial would help but Mnkd doesn’t have the money thanks to the stupid shorts. But the longer the company survives the greater chance it will have to be broadly accepted in diabetes world. Time will tell. So true |
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Post by ktim on Mar 9, 2020 12:25:15 GMT -5
mnkd needs some kind of trial data for the sales reps to work with so they can sell it.. does it have to be expensive large trial data? It sounds like Endos are way under dosing.. which from personal experience I believe to be true. It is so frustrating.. does Mnkd not understand their own drug and what they need to do to be able to sell it? I'm so past trying to find someone or something to blame.. what is the solution.. let's find it and do it!!! Large, long trials are financially out of the question. It may well be that additional smaller, shorter trials would be necessary to obtain the financial resources (via higher share price). Question would be which would be sufficient in addition to necessary. I can think of a few pilot studies that might change the conversation with the investment community. - Trial in T1s that jointly optimizes basal and prandial titration. It seems that anecdotal results have been significantly better than MNKDs trials. It could purely be selection bias of these anecdotal results, but it seems this is one issue that could account for the difference. MNKD should by now have a pretty good feel for whether this is an issue. - Trial looking at early intensive insulin in T2. Can Afrezza produce impressive results, while not posing significant hypo risk? Though this one might not have an economic argument... would payers simply never get on board with early insulin use... is it a safety issue or is it primarily economic. - STAT results were rather mixed due to non-compliance. Is the non-compliance level what could really be expected in the ideal scenario, or were the doctors simply not convincing enough. Now that MNKD has STAT and the results of the compliant group, could they repeat and convince more patients to be compliant... or is it really what Aged says about follow on dosing simply being something many PWDs will refuse. |
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Post by agedhippie on Mar 9, 2020 13:22:54 GMT -5
... - Trial looking at early intensive insulin in T2. Can Afrezza produce impressive results, while not posing significant hypo risk? Though this one might not have an economic argument... would payers simply never get on board with early insulin use... is it a safety issue or is it primarily economic. - STAT results were rather mixed due to non-compliance. Is the non-compliance level what could really be expected in the ideal scenario, or were the doctors simply not convincing enough. Now that MNKD has STAT and the results of the compliant group, could they repeat and convince more patients to be compliant... or is it really what Aged says about follow on dosing simply being something many PWDs will refuse. Early insulin - for insurers it's a cost issue with safety as a very distant second. There are knock-ons to prescribing insulin that increase insurers' costs because historically meal time insulin was a last line so the protocols require lots of add-ons that insurers would rather not prescribe. That's before you compare the cost of insulin with metformin. My feeling is that doctors would not expect their patients to remain compliant although they may start out compliant. It's a life style change and like other life style changes such as diet some people will stick to it, but most drop out. That's before you get to the whole burnout question. My views on this are well known though  |
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Post by ktim on Mar 9, 2020 13:27:24 GMT -5
... - Trial looking at early intensive insulin in T2. Can Afrezza produce impressive results, while not posing significant hypo risk? Though this one might not have an economic argument... would payers simply never get on board with early insulin use... is it a safety issue or is it primarily economic. - STAT results were rather mixed due to non-compliance. Is the non-compliance level what could really be expected in the ideal scenario, or were the doctors simply not convincing enough. Now that MNKD has STAT and the results of the compliant group, could they repeat and convince more patients to be compliant... or is it really what Aged says about follow on dosing simply being something many PWDs will refuse. Early insulin - for insurers it's a cost issue with safety as a very distant second. There are knock-ons to prescribing insulin that increase insurers' costs because historically meal time insulin was a last line so the protocols require lots of add-ons that insurers would rather not prescribe. That's before you compare the cost of insulin with metformin. My feeling is that doctors would not expect their patients to remain compliant although they may start out compliant. It's a life style change and like other life style changes such as diet some people will stick to it, but most drop out. That's before you get to the whole burnout question. My views on this are well known though Unfortunately in STAT a significant number started out non-compliant. Though that certainly makes sense that the rate of compliance probably would drop over time. |
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Post by rfogel on Mar 9, 2020 14:17:07 GMT -5
One problem I see with initiating a large trial is that the company would risk getting the same or possibly worse results, and then all of that money would have been spent for nothing. If anything, they should at least try for some phase 1 trials with some new drugs that might have potential for partnerships.
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