I can tell you that my GF was not allowed by insurance to have both afrezza AND the pump since it was considered a dual prescription for meal time insulin. I can also tell you that she loves being free of the pump. She hated changing sites, and all the scarring it caused in her abdomen.
JDRF did tons of work on the artificial pancreas and they clearly stated that the biggest shortfall was that they needed a faster insulin for mealtime, and they used Afrezza for that purpose.
Here is the stat from MimiMed itself, "An 11% decline in time spent over 180 mg/dl" its clearly not great at preventing mealtime highs.
Best use of the new pump is in combination with Afrezza just as the JDRF did to replace basal shots.
wow that dude has posted over 11000 times in the last year??? WOW That's once every 45 minutes for an entire year!
Fortunately or unfortunately for my investment, I have seen first hand that age
Aftezza is in fact superior in every way, convenience, better A1C, much fewer lows. Will they ever do trials to demonstrate superior A1c control? Maybe. Clamp studies are all they need to demonstrate superior pk/pk which is enough for superiority. 12 min vs 45? Not even close. I just hope mnkd works toward that superior label ASAP.
I have been of the opinion that Brandicourt appointed Feb19 2015 is the master of Afrezza's demise at SNY. Note CC coverage in Q1 for Afrezza never to be mentioned again after his appointment.
What was the "master plan"? It appears to me that they really did intend to do a very limited targeted roll out to select endocrinologists to learn best practices and determine issues before final major launch, just as they had always advertised to us. Why would they do this?
Because of the revenue split they had to have premium pricing to make afrezza a viable product for them. IMHO they did a slow launch in order to complete the studies to justify label update and premium pricing even at the expense of first year sales. Fast forward to the study results being posted (I hope they are in fact as positive as the titles imply) and they certainly appear adequate to justify label update and ultra rapid acting designation by the FDA.
We had all been crying for lower price to improve insurance coverage, but we would all agree, from a business stand point, premium pricing + greater insurance coverage based on superiority is even better. The great news now for MNKD is we have much more flexibility on pricing with 100% revenue going to us.
One of the best publication titles is "The variability and Time Action Profile of inhaled Technosphere insulin compares favorably to That of Subcutaneous Regular Human Insulin". This invalidates one of the major push-backs from Endo's that you cant precisely dose with Afrezza compared to injected. This belief is wrong. Anyone living with a diabetic is all to aware of injection site variability, and it appears to be an even greater obstacle than inhalation.
I hope management is fast forwarding their efforts to update the label with the FDA.
People here give you a lot of #$%$ as you know but nobody puts in the time and effort you do. Thank you for your effort, time and especially your generosity to share the information with us! I wouldn't have blamed you one bit not to share anything with the people who treat you so badly! Thanks!!
Thank you for update. Any color provided on vdex, or timeline for international partners? Thnx Kevin!
Good find btw kevin. I had worried that the contract with Amphistar would be a problem. I wonder if MNKD gets the 50M in insulin?
What does this get us exactly? Relief from contract to buy from Amphistar? Thoughts?
I couldn't agree more. It takes time to dial it in, as Eric is always saying but once you do this insulin is the best on the market, hands down. Once Docs have the confidence in this product to encourage their patients to not only switch but to stick with it, the flood gates will be opened.