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Post by sweedee79 on Feb 22, 2019 14:56:32 GMT -5
I don’t think they have any intention on doing a long-term study and matt and aged know that. Cost is too high. At least at this point in time. Unless we get a partner the long trial data is water under the bridge.. we all know this. So yeah, I have no idea why they keep bringing it up or why they are even here. I believe MNKD is trying to attract a partner or investor.. while at the same time trying to build scripts.. and market our pipeline and technosphere.. that's the plan.. |
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Post by lakers on Feb 22, 2019 15:03:31 GMT -5
I don’t think they have any intention on doing a long-term study and matt and aged know that. Cost is too high. At least at this point in time. Doing that right now would bankrupt the co. Of course, they know that but keep harping on their genius idea as though Mnkd had several hundred millions dollars budget. Perhaps, that’s exactly what they want.... ulterior motives? The OOC T2 Study, If successful, will render ST (Step Therapy) requirement moot, allow MDs to forgo ST, and coverage plans to drop ST requirement for Afrezza. This study is a very useful, great tool to negotiate for better insurance coverage, and will contribute directly to Afrezza proliferation. Primary Outcome Measures : Percentage change from baseline HbA1c [ Time Frame: 3 months ] Demonstrate that the addition of mealtime Afrezza can significantly lower HbA1c within 3 months in uncontrolled type 2 diabetes patients initially having HbA1c of 7.5 or higher, despite at least 6 months of prior therapy with diabetes medications. Secondary Outcome Measures : Percentage of patients having HbA1c under 7% [ Time Frame: 3 months ] Percent of time that Blood glucose (BG) is under 70 mg/dL on CGMS [ Time Frame: 3 months ] |
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Post by lakers on Feb 22, 2019 15:13:43 GMT -5
I don’t think they have any intention on doing a long-term study and matt and aged know that. Cost is too high. At least at this point in time. Unless we get a partner the long trial data is water under the bridge.. we all know this. So yeah, I have no idea why they keep bringing it up or why they are even here. I believe MNKD is trying to attract a partner or investor.. while at the same time trying to build scripts.. and market our pipeline and technosphere.. that's the plan.. Public info: “We have been working diligently with our partner in Brazil and regulatory authorities to secure our first approval outside the U.S. and hope to have an update for you on this surely as the holidays slowed down our review unfortunately. We need to finish our part one of our pediatric program to file what is known as a PIP in the EU before we can engage in a meaningful filing application for Europe. We anticipate filing in Canada in the first half of 2019 and meeting with the European regulatory authorities to start a [indiscernible] over there as these are the two most common places where we get requests for Afrezza from our international inquiries.We know it takes time to gain regulatory approval in these markets and we’ll make appropriate call to look for one go-to-partner ex-U.S. or continue to find key partners in each market like we did with Brazil and India.” |
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Post by akemp3000 on Feb 22, 2019 15:14:47 GMT -5
Regardless of more testing, Mannkind and the diabetic community finally seems to be making good progress in spreading the word about Afrezza's superiority. The scripts, ADA and the financial markets haven't caught up just yet but it now seems inevitable. The superior science for TIR and improved quality of life won't allow an option. IMO, it's really that simple. Mike just has to keep driving the train.
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Post by sportsrancho on Feb 22, 2019 15:19:41 GMT -5
I don’t think they have any intention on doing a long-term study and matt and aged know that. Cost is too high. At least at this point in time. Unless we get a partner the long trial data is water under the bridge.. we all know this. So yeah, I have no idea why they keep bringing it up or why they are even here. I believe MNKD is trying to attract a partner or investor.. while at the same time trying to build scripts.. and market our pipeline and technosphere.. that's the plan.. So speculating on a plan..what if they announced we were copromoting with Dexcom, the 10% of the salesforce they laid off was to make room for us and our salesforce.. that would blow the share price through all the warrants even though there would be no money upfront, then there would be dilution because of the warrants but that would take us down the road quite a long ways. Or maybe they’re working on getting the black box warning off the label. Just hoping for a surprise in Mike’s back pocket. |
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Post by agedhippie on Feb 22, 2019 15:20:52 GMT -5
I don’t think they have any intention on doing a long-term study and matt and aged know that. Cost is too high. At least at this point in time. I think at this immediate moment the money isn't there. However after the December offering there is another $42 million in warrants sitting out there which I reckon gets exercised at some point. |
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Post by agedhippie on Feb 22, 2019 15:24:38 GMT -5
And a quick detour. I am just completing a Tidepool questionnaire and they have Afrezza as an insulin option - that wasn't in the last one.
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Post by ktim on Feb 22, 2019 15:33:35 GMT -5
And a quick detour. I am just completing a Tidepool questionnaire and they have Afrezza as an insulin option - that wasn't in the last one. Are there questions regarding outcomes/satisfaction with one's treatment regime, or merely what is being used? I'm not familiar with this questionnaire. |
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Post by peppy on Feb 22, 2019 15:45:53 GMT -5
And a quick detour. I am just completing a Tidepool questionnaire and they have Afrezza as an insulin option - that wasn't in the last one. Are there questions regarding outcomes/satisfaction with one's treatment regime, or merely what is being used? I'm not familiar with this questionnaire. Additionally, May I ask, What IS a Tidepool questionnaire?  www.calacademy.org/discovery-tidepool-faqs |
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Post by mango on Feb 22, 2019 15:46:57 GMT -5
I don’t think they have any intention on doing a long-term study and matt and aged know that. Cost is too high. At least at this point in time. I think at this immediate moment the money isn't there. However after the December offering there is another $42 million in warrants sitting out there which I reckon gets exercised at some point. Undisclosed pipeline molecule = $30M  |
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Post by lakers on Feb 22, 2019 16:40:14 GMT -5
I think at this immediate moment the money isn't there. However after the December offering there is another $42 million in warrants sitting out there which I reckon gets exercised at some point. Undisclosed pipeline molecule = $30M This corroborates the CTO. Milestone A is $12.5 million Milestone B is $12.5 million Milestone C is $12.5 million Milestone D is $12.5 million Milestone E is $15 million Milestone F is $15 million Milestone Payments (A) through (D) shall be made no more than once (and each only upon the first achievement of the corresponding milestone), irrespective of how many Products achieve the corresponding milestone. Milestone Payments (E) and (F) above may be paid more than once (i.e., if there are multiple Optioned Agents), but each shall be paid only once for the first Optioned Product for each Optioned Agent that reaches the corresponding milestone. MC mentioning $37.5 M over 18 mos refered to A+B+C. UTHR mentioned $25M payment in 2019 = A+B $25M payment in 2020 = C+D Each Undisclosed pipeline molecule if brought forward = $30M = E+F Plus low teen royalty. There can be multiple $30M payments if there are multiple undisclosed molecules and brought forward. The info dovetailed. No more ambiguity. Can we settle this once and for all, SO? |
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Post by brotherm1 on Feb 22, 2019 16:47:53 GMT -5
“Can we settle this once and for all?”
I don’t know Lakers. I don’t know if it’s because I’m aging or if I ate lead paint when I was a kid, but I personally appreciate your reminders because my brain is not what it never was.
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Post by agedhippie on Feb 22, 2019 17:13:49 GMT -5
And a quick detour. I am just completing a Tidepool questionnaire and they have Afrezza as an insulin option - that wasn't in the last one. Are there questions regarding outcomes/satisfaction with one's treatment regime, or merely what is being used? I'm not familiar with this questionnaire. I don't want to hijack the thread so I will start another thread for this. The short answer is what is being used and the results. |
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Post by sayhey24 on Feb 22, 2019 18:36:30 GMT -5
You ain’t see nothing yet. “We anticipate our pediatric program to be Phase III ready by the end of 2019. We also expect a few additional readouts this year from our One Drop study as well as our investigator trial type 2 patients with Dr. Phil Levine in Baltimore. We’re excited to see the interim analysis presented at the upcoming scientific conferences in 2019.” The other trial is significant bc it measures A1C using adaptive Afrezza titration algorithm (ATA) on out of control T2 who have used other RAAs for at least 6 months. Think of it as speeding up Time To A1C Target (TTT). clinicaltrials.gov/ct2/show/NCT03324776?term=Afrezza&rank=1Brief Summary: To examine the effects of adding prandial Afrezza inhaled insulin to patients with type 2 diabetes who are not controlled after at least 6 months of other diabetes treatments including oral agents, basal insulin, or GLP-1 use. ... This is the sort of thing that is immensely frustrating. This is a pointless trial. It has absolutely nothing to do with why endos should use Afrezza rather than other RAA insulins. The trial specifically excludes T2 who are using RAA ( Exclusion criteria: ... Currently using rapid acting insulins - Novolog, Humalog, Apidra), and there is no comparator arm using RAA to show Afrezza outperform RAA options. In the end all you can say is that adding meal time insulin for people who are failing on earlier steps will reduce their A1c. Sorry, but that's already established and covered in the SOC. This is effectively a small scale (40 patients!) rerun of the T2 phase 3 trial, but with CGMs. Stop doing this and have a proper large scale STAT trial that will provide the data to make a difference. Ok - I feel better for that rant. Aged - you seem to have a misunderstanding when it comes to T2 care.
Comparing afrezza to RAA in the T2 world makes ZERO sense. Adding RAAs is the last step in T2 care. RAAs require needles and are considered dangerous for T2s. It they were not they would be Step 1.
Afrezza on the other hand does not have the issues RAAs have. While you as a T1 have told us numerous times PWDs don't mind needles in the T2 world everything is done to avoid insulin because of needles and compliance. The mission of afrezza is to break that paradym and be used as a front line treatment, not Step 3 or Step 4 and not even Step 2. The goal is afrezza first, afrezza always.
That is the goal of this study as stated on the clinical page which says "The goal is to assess how the investigator can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur." The key words are rapidly and safely. In other words, RAAs need not apply.
What Al Mann told us many years ago, as a T2 not on basil or other antiglycemics, getting a hypo on afrezza is really really hard. This was proved out in the Affinity 2 where the only severe hypos were due to TZD use.
What this study does is rebaseline the Affinity 2 results proper dosing with the adaptive algorithm. By doing this there is no need to do another large scale study. A bench study can be done. What we learned on Affinity 2 was PWDs were under-dosed.
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Post by uvula on Feb 22, 2019 18:56:46 GMT -5
Great discussion which would not have happened if we didn't have people pushing against each other. Go mnkd.
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