|
|
Post by agedhippie on Nov 14, 2016 21:16:33 GMT -5
The FDA requirement on Mannkind is for a 5 year randomized, controlled trial in 8,000 to 10,000 patients with Type 2 diabetes. The primary objective is to assess the lung cancer risk. The secondary objectives are cardiovascular risk and the long-term effect of Afrezza on pulmonary function. The randomized group is to be made up of 50% Afrezza users and 50% using the standard of care. The group must be at high risk of lung cancer.
The trial should have already started but I seem to remember it getting deferred.
|
|
|
|
Post by cjc04 on Nov 14, 2016 21:28:26 GMT -5
Mannmade, I think you're exactly right, and THAT is the biggest problem. My wife, T1 with a 6.5 a1c, was told by multiple endos that she was fine, 6.5 is great.... however, she was up in the middle of the night 3 to 5 times week with low bs. SO, if you're having so many lows, and your a1c is a "great" 6.5, then what kind of highs must you be having to average it out?  ? Sure enough, when she went on a trial CGM for two weeks, she was hitting numbers in the 400's.... So,,,, super highs and super lows gets you a "great" a1c number, and endos are happy. Ridiculous! btw,,,,, 5.7 a1c after 3 months on Afrezza. cj a perfect summary of what seems to be the issue. Digital technology as you point out will help but it will all take time... [ Yes, I think a noninvasive CGM is the answer to everything... noninvasive being the key, because she won't wear a CGM, can't deal with it. Maybe just as important is this false sense of security In relying on the A1c measurement. I am shocked that extreme lows and extreme highs give an acceptable number to everyone, it's not acceptable it's dangerous. The most important thing I should have mentioned with my wife's 5.7 is that it comes with ZERO low bs in the middle of the night,,,,, which means she's not experiencing high numbers during the day for her to avg out at a 5.7.... all without a CGM. |
|
|
|
Post by dreamboatcruise on Nov 14, 2016 21:57:36 GMT -5
cj a perfect summary of what seems to be the issue. Digital technology as you point out will help but it will all take time... [ Yes, I think a noninvasive CGM is the answer to everything... noninvasive being the key, because she won't wear a CGM, can't deal with it. Maybe just as important is this false sense of security In relying on the A1c measurement. I am shocked that extreme lows and extreme highs give an acceptable number to everyone, it's not acceptable it's dangerous. The most important thing I should have mentioned with my wife's 5.7 is that it comes with ZERO low bs in the middle of the night,,,,, which means she's not experiencing high numbers during the day for her to avg out at a 5.7.... all without a CGM. Seems like we're still at least a couple of years away from noninvasive CGM on market. |
|
|
|
Post by lakers on Nov 15, 2016 0:26:47 GMT -5
"4. Epi Hale Progress towards a early 2018 Product Launch". This is a little bit shock to me. Any source that this trial could be done so quick? I believe Ray said, a couple of CCs ago, that they only had to show bio-equivalency. That's why they fast-tracked epi -- don't have to run the whole gauntlet. The last slide, the last one of our clinical development candidates is Epinephrine for Anaphylaxis. I think the one point I want to raise here is this can be an incredibly short timeline. No real clinical studies would be required. Obviously you cannot do a clinical study in the Anaphylactic setting. So that would be e-study and some human factor studies would probably suffice. So we're looking at this opportunity as again one of our priority ones. MannKind's (MNKD) CEO Matt Pfeffer Presents At 34th Annual JPMorgan Healthcare Conference (Transcript) $MNKD www.seekingalpha.com/article/3809206 |
|
|
|
Post by peppy on Nov 15, 2016 6:22:11 GMT -5
cj a perfect summary of what seems to be the issue. Digital technology as you point out will help but it will all take time... [ Yes, I think a noninvasive CGM is the answer to everything... noninvasive being the key, because she won't wear a CGM, can't deal with it. Maybe just as important is this false sense of security In relying on the A1c measurement. I am shocked that extreme lows and extreme highs give an acceptable number to everyone, it's not acceptable it's dangerous. The most important thing I should have mentioned with my wife's 5.7 is that it comes with ZERO low bs in the middle of the night,,,,, which means she's not experiencing high numbers during the day for her to avg out at a 5.7.... all without a CGM. Thanks for our honest discussion. I am struck by the ins and outs of the protocol. The HgA1c, a perimeter that was put into place by medicine less than ten years ago has become the go to testimonial of effectiveness. A new version of Latin introduced to the spiritual communion of medicine. A new version of double speak. Additionally the protocol states, the HgA1c goal should be made obtainable. Interesting the diabetic is to have the appropriate behavior to manage their blood glucose levels well with medicine that performs badly. Additionally the diabetic is responsible to inject this poorly acting insulin well to make it all work. This is all being done for the diabetics own good, because if you use an insulin that you inhale you may get lung cancer.
Lung Cancer, I had grandmothers that smoked into their 80's. one died at 89 one died at 91. I had a type one diabetic friend died of a heart attack in her 40's. I have seen type ones live into their 70's.
hmmm
|
|
?
