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Post by harryx1 on Feb 22, 2019 10:49:33 GMT -5
I think Aged is referring to the Levine clinical out of Maryland Doesn't matter, he will still spew the same crap he's always been doing for any trial.
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Post by harryx1 on Feb 22, 2019 11:07:33 GMT -5
I can’t wait to tweet him.. Boy this IS fun😂 LOL!!
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Post by agedhippie on Feb 22, 2019 11:12:23 GMT -5
I think Aged is referring to the Levine clinical out of Maryland Doesn't matter, he will still spew the same crap he's always been doing for any trial. Yeah, you are talking about the wrong trial.
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Post by harryx1 on Feb 22, 2019 11:28:05 GMT -5
You still bash the A-One trial. Maybe that trial is precursor to a bigger trial once they see the outstanding results when a T2 goes straight to Afrezza without any prior knowledge of outdated subq insulin.
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Post by matt on Feb 22, 2019 11:32:46 GMT -5
Straight from the trial site... Estimated Enrollment : 400 participants You are citing a different study, the one AgedHippie refers to is indeed 40 patients. His point is valid that there is not active comparator allowed from the currently marketed RA insulins which rather stacks the deck in favor of Afrezza and an outcome that is nearly a foregone conclusion. If you measure your post-prandial glucose and find that it is out of range, a puff of Afrezza should certainly make the level go down. The only surprising outcome from that trial would be that Afrezza did not reduce the glucose level. So yes, Afrezza will reduce glucose and it will almost certainly be a statistically significant difference but that is not an apples-to-apples comparison for the vast majority of diabetics who use a RA insulin. Why not expend money and effort on a trial that compares Afrezza in a head-to-head comparison of competitive products? Physicians would be more influenced by that sort of data.
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Post by harryx1 on Feb 22, 2019 11:37:27 GMT -5
There is over 13+ years of data for T2s going on subq insulin and guess what!!!! >>> approximately 70% of T2D still don’t meet their A1c (<7) goal. <<<
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Post by mnholdem on Feb 22, 2019 11:59:02 GMT -5
Presentations build awareness, comparitors or not, especially during the TV ad campaign. I was at my dentist on Wednesday and he mentioned seeing the Afrezza ad. I didn’t even bring up the subject. He simply remembers me talking about Afrezza 6 months ago.
Even though he’s an oral surgeon, it reminded me that there may be many physicians who are interested in learning more about inhaled insulin, comparisons to RAA or not.
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Post by agedhippie on Feb 22, 2019 12:15:28 GMT -5
You still bash the A-One trial. Maybe that trial is precursor to a bigger trial once they see the outstanding results when a T2 goes straight to Afrezza without any prior knowledge of outdated subq insulin. I want to see the result of the A-One trial. Right now we know how Afrezza did, but not how RAA did (we do know how RAA did for T1, but these are T2). For my money we already have the precursor in STAT-1 which was a pilot. The pilot worked, now is the time for a large scale STAT-2.
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Post by sweedee79 on Feb 22, 2019 12:56:08 GMT -5
You still bash the A-One trial. Maybe that trial is precursor to a bigger trial once they see the outstanding results when a T2 goes straight to Afrezza without any prior knowledge of outdated subq insulin. I want to see the result of the A-One trial. Right now we know how Afrezza did, but not how RAA did (we do know how RAA did for T1, but these are T2). For my money we already have the precursor in STAT-1 which was a pilot. The pilot worked, now is the time for a large scale STAT-2. How long would a large scale STAT 2 study take and how much money? Do we have the time and money for that without continuous dilution? Seems to me the management is trying to prove the merits of a partnership or investment as well as spread awareness to the profession.. as well as patients . We have gained the attention of UTHR, and many others.. The company seems to be building credibility and awareness. You never know when the right person will step up.. Afrezza is the real deal.. I don't see how this doesn't catch the eye of someone.. We are changing the SOC.. it's huge.. why this has taken so long is mind boggling to me.. there is real money to be made here and lives to change for the better.. it's utterly frustrating.. MNKD is banging on the door!!!!!
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Post by mango on Feb 22, 2019 13:28:07 GMT -5
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Post by agedhippie on Feb 22, 2019 13:37:30 GMT -5
I want to see the result of the A-One trial. Right now we know how Afrezza did, but not how RAA did (we do know how RAA did for T1, but these are T2). For my money we already have the precursor in STAT-1 which was a pilot. The pilot worked, now is the time for a large scale STAT-2. How long would a large scale STAT 2 study take and how much money? Do we have the time and money for that without continuous dilution? Seems to me the management is trying to prove the merits of a partnership or investment as well as spread awareness to the profession.. as well as patients . We have gained the attention of UTHR, and many others.. The company seems to be building credibility and awareness. You never know when the right person will step up.. Afrezza is the real deal.. I don't see how this doesn't catch the eye of someone.. We are changing the SOC.. it's huge.. why this has taken so long is mind boggling to me.. there is real money to be made here and lives to change for the better.. it's utterly frustrating.. MNKD is banging on the door!!!!! To be honest I don't know the cost, numbers on the net say around $19M. For time I would estimate 18 months (six months recruiting and spin up, 6 months run, 6 months results and clean up) but it might be possible to compress that. Matt would have a far better idea than me on those numbers. It sucks, but I don't think a lot changes until it is done. We need to show compelling results in a format they accept and sadly that's trial data.
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Post by longliner on Feb 22, 2019 13:58:28 GMT -5
Doesn't matter, he will still spew the same crap he's always been doing for any trial. Yeah, you are talking about the wrong trial. Since this thread is about MNKD and One Drop, It would appear YOU are talking about the wrong trial. Nice attempt at a pivot though! Oops, I see you were responding to Lakers.
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Post by mango on Feb 22, 2019 14:14:35 GMT -5
I want to see the result of the A-One trial. Right now we know how Afrezza did, but not how RAA did (we do know how RAA did for T1, but these are T2). For my money we already have the precursor in STAT-1 which was a pilot. The pilot worked, now is the time for a large scale STAT-2. How long would a large scale STAT 2 study take and how much money? Do we have the time and money for that without continuous dilution? Seems to me the management is trying to prove the merits of a partnership or investment as well as spread awareness to the profession.. as well as patients . We have gained the attention of UTHR, and many others.. The company seems to be building credibility and awareness. You never know when the right person will step up.. Afrezza is the real deal.. I don't see how this doesn't catch the eye of someone.. We are changing the SOC.. it's huge.. why this has taken so long is mind boggling to me.. there is real money to be made here and lives to change for the better.. it's utterly frustrating.. MNKD is banging on the door!!!!! I believe it's mostly because ADA is a slush fund and the rules of their game is you have to pay to play. Aftezza totally disrupts their cushy criminal operation, and no amount or size of clinical trials will change that. The opposition will always use diversion tactics, and saying we need more clinical trial data is one of those. Metformin is recommended first line therapy and just look at the crap ADA uses to support that.
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Post by sportsrancho on Feb 22, 2019 14:20:54 GMT -5
I don’t think they have any intention on doing a long-term study and matt and aged know that. Cost is too high. At least at this point in time.
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Post by longliner on Feb 22, 2019 14:46:11 GMT -5
I don’t think they have any intention on doing a long-term study and matt and aged know that. Cost is too high. At least at this point in time. When we are on a shoestring, the scream for more spending by folks outside the company is only to attract more voices to bring down Mannkind. When funding is no longer an issue the voices will die away.
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