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Post by goyocafe on May 17, 2018 9:44:58 GMT -5
So they can use the data from these studies even though the FDA issued a CRL denying the same? How many of these studies were done with the medtone inhaler? I personally think the FDA is all wet, but I’m curious if something has changed there to allow this data into the mix?
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Post by liane on May 17, 2018 9:47:07 GMT -5
So they can use the data from these studies even though the FDA issued a CRL denying the same? How many of these studies were done with the medtone inhaler? I personally think the FDA is all wet, but I’m curious if something has changed there to allow this data into the mix? I don't see why they couldn't use the data. MNKD did the bridge study comparing the 2 inhalers.
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Post by goyocafe on May 17, 2018 9:55:17 GMT -5
So they can use the data from these studies even though the FDA issued a CRL denying the same? How many of these studies were done with the medtone inhaler? I personally think the FDA is all wet, but I’m curious if something has changed there to allow this data into the mix? I don't see why they couldn't use the data. MNKD did the bridge study comparing the 2 inhalers. Completely agree, but they were issued a CRL based on the bridge study. I just wonder if there’s been a change at the FDA. Or there is a lower bar for using study data than there is for approval/label.
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Post by centralcoastinvestor on May 17, 2018 9:57:08 GMT -5
I don't see why they couldn't use the data. MNKD did the bridge study comparing the 2 inhalers. Completely agree, but they were issued a CRL based on the bridge study. I just wonder if there’s been a change at the FDA. Or there is a lower bar for using study data than there is for approval/label. Or smarter people explaining what the data means.
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Post by mannmade on May 17, 2018 9:59:06 GMT -5
One quick clarification Mike C stated almost all patents good until 2031/32 and there are over 800 of them. He has never seen a drug so well protected. It is very expensive to do.
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Post by goyocafe on May 17, 2018 10:00:54 GMT -5
Completely agree, but they were issued a CRL based on the bridge study. I just wonder if there’s been a change at the FDA. Or there is a lower bar for using study data than there is for approval/label. Or smarter people explaining what the data means. Hey, whatever works! I’ve always thought it was a lame CRL. The bridge study showed equivalent concentrations of insulin, should have been enough.
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Post by cjm18 on May 17, 2018 10:08:54 GMT -5
One quick clarification Mike C stated almost all patents good until 2031/32 and there are over 800 of them. He has never seen a drug so well protected. It is very expensive to do. Nice. His presentation slides showed this in the past. His 7-10 year comment must refer to competitors trying to make a near as fast insulin?
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Post by mannmade on May 17, 2018 10:09:43 GMT -5
Also both Mike and Dr. Kendall stated they did not see or know of another product that can do as well what AFREZZA can do coming along in next 10 year’s.
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Post by brentie on May 17, 2018 11:03:14 GMT -5
I don't see why they couldn't use the data. MNKD did the bridge study comparing the 2 inhalers. Completely agree, but they were issued a CRL based on the bridge study. I just wonder if there’s been a change at the FDA. Or there is a lower bar for using study data than there is for approval/label. They did reject the first bridge study, however they did a second one(171) after the second CRL. And that one was approved. "“We are pleased that Study 171 met its primary endpoint of non-inferiority, by demonstrating that Afrezza produces A1c reductions comparable to insulin aspart,” stated Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. “Importantly, this study also established a bridge between the Gen2 inhaler and the large body of pulmonary safety data that was previously collected for Afrezza using the MedTone inhaler." www.drugs.com/nda/afrezza_130814.htmlAfrezza approval history www.drugs.com/history/afrezza.html
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Post by peppy on May 17, 2018 11:12:30 GMT -5
Completely agree, but they were issued a CRL based on the bridge study. I just wonder if there’s been a change at the FDA. Or there is a lower bar for using study data than there is for approval/label. They did reject the first bridge study, however they did a second one(171) after the second CRL. And that one was approved. "“We are pleased that Study 171 met its primary endpoint of non-inferiority, by demonstrating that Afrezza produces A1c reductions comparable to insulin aspart,” stated Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. “Importantly, this study also established a bridge between the Gen2 inhaler and the large body of pulmonary safety data that was previously collected for Afrezza using the MedTone inhaler." www.drugs.com/nda/afrezza_130814.htmlAfrezza approval history www.drugs.com/history/afrezza.htmlBrent, what an avatar. I think is coca-cola. So funny, except the part when it looks like she could be in seizure. Thanks for being the Study and data expert.
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Post by goyocafe on May 17, 2018 11:47:18 GMT -5
Completely agree, but they were issued a CRL based on the bridge study. I just wonder if there’s been a change at the FDA. Or there is a lower bar for using study data than there is for approval/label. They did reject the first bridge study, however they did a second one(171) after the second CRL. And that one was approved. "“We are pleased that Study 171 met its primary endpoint of non-inferiority, by demonstrating that Afrezza produces A1c reductions comparable to insulin aspart,” stated Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. “Importantly, this study also established a bridge between the Gen2 inhaler and the large body of pulmonary safety data that was previously collected for Afrezza using the MedTone inhaler." www.drugs.com/nda/afrezza_130814.htmlAfrezza approval history www.drugs.com/history/afrezza.htmlThanks so much for pointing this out. I never realized 171 actually served as a bridge as well.
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Post by Omega on May 17, 2018 11:54:12 GMT -5
Thank you everyone who have posted their meeting experiences, It is very much appreciated.
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Post by minnlearner on May 17, 2018 12:13:02 GMT -5
Yes! THANK YOU ALL!! I wish I could have been there and met all of you!
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Post by mnholdem on May 17, 2018 12:13:40 GMT -5
We've yet to hear from Beazer... oh, wait! Never mind!
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Post by ilovekauai on May 17, 2018 12:18:36 GMT -5
Also, I was able to try Afrezza for the first time at the welcome dinner thanks to generosity of a fellow investor and inhaled one 4-uint cartridge prior to the start of my 12 oz filet mignon dinner with all the trimmings and w/bread, then the other halfway thru my meal. My BG stayed a rock steady 91. That's incredible. Granted I'm in shape, exercise daily, and have great control, but nothing like that when eating. And using that cool Dreamboat and then actually inhaling Afrezza made me feel like I just walked into the 21st century. I'm the perfect candidate for early intervention of Afrezza that Kendall mentioned as a target market. We'd all thrive on Afrezza for mealtime control, and that's all we'd need. No other drugs necessary.
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