|
PDUFA
Sept 28, 2017 20:09:10 GMT -5
Post by seanismorris on Sept 28, 2017 20:09:10 GMT -5
If they just tack on Ultra to the Label I’ll be disappointed.
|
|
|
Post by bones1026 on Sept 28, 2017 20:30:31 GMT -5
If they just tack on Ultra to the Label I’ll be disappointed. Really? Based on our history with the FDA, and the fact that we can market our product as the ONLY ultra rapid insulin, would be huge, and also open doors with insurance...I'd love it
|
|
|
Post by agedhippie on Sept 28, 2017 21:47:18 GMT -5
If they just tack on Ultra to the Label I’ll be disappointed. Really? Based on our history with the FDA, and the fact that we can market our product as the ONLY ultra rapid insulin, would be huge, and also open doors with insurance...I'd love it The problem is that there is an easy out - "it's ultra-rapid, so what, it still worse outcomes than RAA in trials". This is why I keep on banging on about the need for new trials to prove superiority. Until there is a superiority trial the insurers just see an insulin that costs more than RAA and under-performs, and ultra-rapid alone is not compelling enough to make them move off their current lucrative contracts. The most likely outcome is that they continue as they do today.
|
|
|
PDUFA
Sept 28, 2017 22:06:38 GMT -5
via mobile
Post by ghochr on Sept 28, 2017 22:06:38 GMT -5
Really? Based on our history with the FDA, and the fact that we can market our product as the ONLY ultra rapid insulin, would be huge, and also open doors with insurance...I'd love it The problem is that there is an easy out - "it's ultra-rapid, so what, it still worse outcomes than RAA in trials". This is why I keep on banging on about the need for new trials to prove superiority. Until there is a superiority trial the insurers just see an insulin that costs more than RAA and under-performs, and ultra-rapid alone is not compelling enough to make them move off their current lucrative contracts. The most likely outcome is that they continue as they do today. Is reality taken well here?
|
|
|
Post by rockstarrick on Sept 28, 2017 22:08:02 GMT -5
Ahh yes 😂😂 and don't forget a random "HALTED !!" 😎 GET READY:-)) 😂😂😂😂😂😂😂😂
|
|
|
Post by rockstarrick on Sept 28, 2017 22:12:34 GMT -5
😂😂😂😂😂😂😂😂 After reading that comment I had to do a stroll down memory lane,,,,,, holy fricken shitski, I was quite the pump monkey. 😂😂😂😂😂😂😂😂😂😂
|
|
|
Post by mnholdem on Sept 28, 2017 23:10:18 GMT -5
Really? Based on our history with the FDA, and the fact that we can market our product as the ONLY ultra rapid insulin, would be huge, and also open doors with insurance...I'd love it The problem is that there is an easy out - "it's ultra-rapid, so what, it still worse outcomes than RAA in trials". This is why I keep on banging on about the need for new trials to prove superiority. Until there is a superiority trial the insurers just see an insulin that costs more than RAA and under-performs, and ultra-rapid alone is not compelling enough to make them move off their current lucrative contracts. The most likely outcome is that they continue as they do today. Except for the fact that the FDA itself acknowledged last summer that a1C is an inadequate measurement by bringing together respected diabetes leaders to discuss new and better measurements. Unless I'm mistaken, MannKind submitted testing data demonstrating significant reduction of hyperglycemia and reduced hypoglycemic excursions by utilizing follow up dosing. I believe the comparator was lispro and Afrezza blew them out of the water. Time-in-range, frequency and severity of hyperglycemic and hypoglycemic excursions (both of which cause physiological damage) and another half-dozen key measurements were acknowledged to be better than a1C. The most critical data submitted to the FDA were related to reduced hypoglycemic excursions and mention was made that during pre-approval FDA ttesting, trial doctors often dosed Afrezza too early because they had been conditioned decades of QC insulin PK/PD to expect hyperglycemic episodes if dosing wasn't administered 15-30 minutes prior to eating. The FDA's lead physician was soundly criticized by committee members at the 2014 ADCOM meeting for his poor handling of the trial protocols. About a year ago I posted the scathing remarks here on ProBoards. The diabetes industry and the FDA are currently undergoing important changes. The science will prevail. Examples of study data available prior to submitting the sNDA for label upgrade:
|
|
|
Post by itellthefuture777 on Sept 29, 2017 1:41:10 GMT -5
|
|
|
PDUFA
Sept 29, 2017 2:30:26 GMT -5
via mobile
chc likes this
Post by mikekasem on Sept 29, 2017 2:30:26 GMT -5
im actually hoping we get to 1$ again so I can load up
|
|
|
PDUFA
Sept 29, 2017 2:32:42 GMT -5
via mobile
Post by mikekasem on Sept 29, 2017 2:32:42 GMT -5
Let's hope its going to be approval and the market reacts to it Hope so on the best option Mike is going for or at least one of them. After watching the AdCom however I am forever skeptical of the FDA taking the scientific approach with us. Early info from FDA or games by the Market. Makers? $2.17 currently on 2.1 million traded I hope it retreats to 1$ so I can load up more!
|
|
|
Post by peppy on Sept 29, 2017 3:30:53 GMT -5
Hope so on the best option Mike is going for or at least one of them. After watching the AdCom however I am forever skeptical of the FDA taking the scientific approach with us. Early info from FDA or games by the Market. Makers? $2.17 currently on 2.1 million traded I hope it retreats to 1$ so I can load up more! nothing wrong with loading here.
|
|
|
Post by oldfishtowner on Sept 29, 2017 6:43:36 GMT -5
Really? Based on our history with the FDA, and the fact that we can market our product as the ONLY ultra rapid insulin, would be huge, and also open doors with insurance...I'd love it The problem is that there is an easy out - "it's ultra-rapid, so what, it still worse outcomes than RAA in trials". This is why I keep on banging on about the need for new trials to prove superiority. Until there is a superiority trial the insurers just see an insulin that costs more than RAA and under-performs, and ultra-rapid alone is not compelling enough to make them move off their current lucrative contracts. The most likely outcome is that they continue as they do today. The STAT (time in range) study is scheduled to be completed next month. It could be a proxy for a superiority study until MNKD has the cash to conduct a more robust trial. That together with a revised label that acknowledges a 5-minute onset and allows follow-on doses may be all that is needed.
|
|
|
PDUFA
Sept 29, 2017 12:02:52 GMT -5
Post by dreamboatcruise on Sept 29, 2017 12:02:52 GMT -5
The problem is that there is an easy out - "it's ultra-rapid, so what, it still worse outcomes than RAA in trials". This is why I keep on banging on about the need for new trials to prove superiority. Until there is a superiority trial the insurers just see an insulin that costs more than RAA and under-performs, and ultra-rapid alone is not compelling enough to make them move off their current lucrative contracts. The most likely outcome is that they continue as they do today. The STAT (time in range) study is scheduled to be completed next month. It could be a proxy for a superiority study until MNKD has the cash to conduct a more robust trial. That together with a revised label that acknowledges a 5-minute onset and allows follow-on doses may be all that is needed. And indicates a more aggressive titrating up of quantity since it seems the unit to unit conversion is suboptimal in most cases.
|
|
|
PDUFA
Sept 30, 2017 13:31:33 GMT -5
Post by tmann on Sept 30, 2017 13:31:33 GMT -5
"multiple arrests in several jurisdictions."
|
|
|
Post by boytroy88 on Sept 30, 2017 13:37:32 GMT -5
"multiple arrests in several jurisdictions." Huh?
|
|