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Post by Clement on Aug 9, 2019 9:29:05 GMT -5
Previously I posted, "Less than 9 weeks until we hear the decision from UTHR about the undisclosed molecule! (per MC in the Earnings Call) Read more: mnkd.proboards.com/thread/11398/mnkd-hold-2019-financial-results?page=13#ixzz5w6WCY8XPThen a poster said that a yes is likely expected by most people and somewhat baked in. A yes means UTHR decided to advance the undisclosed molecule. In response to that I cheered because it brings in an additional $30 million (in two parts) of milestones (in addition to the future TreT milestones which were specified in the EC.) Why 9 weeks I wonder. In the EC, Mike said we will get a decision from UTHR concerning the undisclosed molecule in Q3. There are less than 9 weeks left in Q3. |
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Post by prcgorman2 on Aug 9, 2019 9:43:40 GMT -5
The Tndm story and the Mnkd story are two different things.. Were there barriers to the Tndm pump the way there is with Afrezza? We have massive walls to penetrate..SOC.. lack of doc support.. noninferior status.. lack of awareness and knowledge of titration.. I'm not saying we can't grow sales . But it's going to be slow going. You may know more about the TNDM story than I do, but I think some of the same issues existed in the beginning years... insurance coverage bad, not SOC by ADA, needing to encroach on already established competitors. Though different in that the competitors faced two of those some impediments to adoption. Don't know how quickly docs got on board with believing pumps were superior to pens... perhaps that occurred prior to the medical organizations recommending pumps for T1. As for the comments on trials and affordability... the one possibility for something in the near/medium term might be if some better funded 3rd party were to do a large trial looking at generic linkage between Time In Range and complications/costs. The trial gets long and costly because the events of some complications are relatively rare so lots of data needed to make them appear at statistically significant levels. I think it possible (though can't say so with any degree of professional experience) that smaller trials such as the upcoming one with Dexcom, if they clearly prove significantly better TIR, might combine with TIR to complications/cost trial data to approximate results of MNKD doing extensive trials looking at these types of outcomes themselves. Or... I could be overly hopeful and simply wrong. Another great insightful post ktim.
When I mentioned in my previous post in this thread on improving on "current trajectory" what you said is EXACTLY what I had in mind, but could not have stated it as well.
What I also like about your post and why it resonates so well with me is because what you described is what Mannkind, under the able stewardship of current leadership, is doing. And that should provide you some comfort that your assumptions line up with the professionals following the path you described.
It makes 100% complete sense. Mannkind does not have the money for the large scale trials with the many thousands of participants needed to be able to confidently analyze observations in experiment/control groups with less or more comorbidity. What you've described is achievable, is on the roadmap, and will be influential to some degree.
From what Stevil described earlier this week, these non-full-scale studies and results are a common feature of big BP marketing as well, so it's clear they think there is value and this is not mere childish foolishness.
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Post by prcgorman2 on Aug 9, 2019 9:49:09 GMT -5
"I wonder if getting JDRF to make the request would help. Maybe that would be a way of leveraging our partnership with them." Slight reality check. Every diabetes related business on the planet is "partners" with the jdrf. I wouldn't expect them to help us if it means upsetting their much bigger partners who donate lots of money. Nothing ventured, nothing gained. Can't hurt to ask. |
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Post by agedhippie on Aug 9, 2019 10:31:12 GMT -5
The larger study would involve multiple medications (not just Afrezza) in head to head studies that examine Time In Range, A1c and long term reduction of diabetic complications. That is where the Gate’s Foundation would be the best funding partner because they don’t care who is best. I understand this is a long shot but what better disease to go after for the Gates Foundation than Diabetes. Couldn’t JDRF support a multiple medication study to see what works best? If not, then they are not really seeking what is best for people with diabetes. I would live it if this happens. Couldn't a large center like the Mayo clinic or the Cleveland Clinic do the study on their own? The only cost is insulin. They already have the doctors and patients. Insulin manufacturers could donate insulin if they want to be included. The cost in trials is in the management of patients and gathering of results, particularly the later. It is one reason why a lot of pharmas are looking at using intelligent devices that self-report, and massive databases for the data as it comes in (IoT and data lakes). Currently they have a small army of people chasing patients for their results and making sure they are taking their meds. |
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Post by prcgorman2 on Aug 9, 2019 17:30:55 GMT -5
Not a debate. It's a discussion on funding clinical trial(s) to prove superiority of Afrezza over conventional RAA insulin. The discussion on ways to pay for clinical trials is an extension of the discussion on the Afrezza marketing roadmap discussed in the earnings report. There was an accepted assumption that clinical trials to prove superiority are currently too expensive and time consuming even with the additional $40M garnered from the debt refinance discussed in the earnings report. This led to the discussion of possible funding options management could explore for clinical trials to prove superiority. I hope that catches you up. There might be more posts like this too. I hope you don't find them objectionable.
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