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Post by agedhippie on Mar 23, 2018 18:32:37 GMT -5
The road to product adoption lies though those who will benefit the most. Patients and Insurance companies. I am reading between the lines of what Mike is telling us: "we go to health insurers and say every hospitalization for hypo is around $14000" "the good and bad news is it's promotionally responsive" "we know it's about the doctor believing and driving the success" "there is a very large opportunity sitting there in the primary care space" "doctors don't believe the results" "the doctors just need to try it. I can't do anything other than say 9 out of 10 docs never even tried the drug" "that's what it takes is that the patients all have great experiences" "as doctors see these great experiences play out it will be a self fulfilling prophecy to become the standard of care" "people all want better health and they all want control" I split my reply because the ER cost argument is just garbage, but the rest of the arguments bear examination. The questions all boil down to one thing, how do you get doctors to use Afrezza. It's a product that requires you to educate the market, it's not like Toujeo where they already know what Lantus is and how to manage it, this is something they are unfamiliar with. Trials like STAT are good, but it's going to take larger trials to highlight the benefits and get their attention. I don't see this as a fast process, look at STAT, but it is definitely doable.
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Post by buyitonsale on Mar 23, 2018 18:45:17 GMT -5
Insurers will also directly benefit on the Quality of Care measure scores (HEDIS and Medicare Stars) if they make Afrezza easily accessible. All payers compete for these scores (especially on the managed care side) for better reimbursement from government and positioning in the marketplace. Specifically, A1C Control and Medication Adherence measures. It's a no brainer with Afrezza. They will see the light soon. Tell them michaelcastagna
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Post by cjc04 on Mar 23, 2018 19:39:59 GMT -5
Even based on the new label, it should be obvious to the professional that time in range should be improved. It starts working faster = BG levels drop faster = better time in range. Faster out = less chance of hypoglycemia. Isn't that enough info to favor Afrezza over others? Doctors already know it's superior but are not willing to try for other reasons... They do not need more data, they need a new conscience and a new soul IMO. I would bet any specialist that has diabetes is using Afrezza instead of any other prandial insulin. "It seems obvious" is not a basis of medical treatment. Especially when that flies in the face of the best data currently out there - the Phase 3 trial. Buyitonsale, I ageee, not only “should” it seem obvious,,,, IT IS OBVIOUS!!! and unfortunately, that still is not enough... Without telling my & my wife’s entire personal story AGAIN (I’m sure you can dig thru my posts if you’re interested) My wife’s endo (who wanted nothing to do with Afrezza, but she had a personal tie with him and she was relentless) saw her A1c go from 6.8 to 5.7 in 6 weeks.... He then saw the results of her 2 week BLIND CGM after being on Afrezza vs the blind 2 weeks before Afrezza, and they were shocking! He couldn’t believe it! And NOT because of A1c results, but the incredible time in range. Yet he is not prescribing Afrezza!! IMO,,,, the endo’s will prescribe Afrezza when they’re told to, or when that is the easy, comfortable, low risk thing to do, and NOT because it’s best for the patient. Endo’s have a conveyer belt of patients coming thru their offices everyday, and they have a perfectly acceptable routine to service them.... They are NOT going to interrupt what works for them out of good will, what’s best for the patient, or even If they MAY have a conscience... It’s sad, but I’m convinced it’s true.
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Post by sportsrancho on Mar 23, 2018 20:04:32 GMT -5
I agree, we need to target the relentless bad-ass patients or celebrities that will demand the drug!
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Post by buyitonsale on Mar 24, 2018 0:36:19 GMT -5
"It seems obvious" is not a basis of medical treatment. Especially when that flies in the face of the best data currently out there - the Phase 3 trial. Buyitonsale, I ageee, not only “should” it seem obvious,,,, IT IS OBVIOUS!!! and unfortunately, that still is not enough... Without telling my & my wife’s entire personal story AGAIN (I’m sure you can dig thru my posts if you’re interested) My wife’s endo (who wanted nothing to do with Afrezza, but she had a personal tie with him and she was relentless) saw her A1c go from 6.8 to 5.7 in 6 weeks.... He then saw the results of her 2 week BLIND CGM after being on Afrezza vs the blind 2 weeks before Afrezza, and they were shocking! He couldn’t believe it! And NOT because of A1c results, but the incredible time in range. Yet he is not prescribing Afrezza!! IMO,,,, the endo’s will prescribe Afrezza when they’re told to, or when that is the easy, comfortable, low risk thing to do, and NOT because it’s best for the patient. Endo’s have a conveyer belt of patients coming thru their offices everyday, and they have a perfectly acceptable routine to service them.... They are NOT going to interrupt what works for them out of good will, what’s best for the patient, or even If they MAY have a conscience... It’s sad, but I’m convinced it’s true. I feel for you, your wife and all patients out there that are at the mercy of doctors that are not wiling to change their routine. It seems to be a vast majority that is resisting to prescribe and I also feel that they are hiding behind every excuse possible... supposedly because they are cautious and need to see more data. Well, these doctors will come around when patients and insurers turn the tables on them. Mannkind needs to figure out a strategy for DTC adverting that fits their budget and bombard all PWD with compelling digital or select markets cable ads that convey the clear message of Afrezza superiority and convenience over injectables. At the same time they need to show time in range data to insurers and quantify the benefits of Afrezza in dollars (the only language they understand). I listened to michaelcastagna latest presentation over and over today and I believe that he and the team understand challenges in front of them and are moving in the right direction.
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Post by lennymnkd on Mar 24, 2018 5:10:21 GMT -5
It is now an EXACT SCIENCE ! AFREZZA.... with the CGM /
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Post by lennymnkd on Mar 24, 2018 6:59:18 GMT -5
It is now an EXACT SCIENCE ! AFREZZA.... with the CGM / no excuses !
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Post by hellodolly on Mar 24, 2018 7:05:52 GMT -5
There is also a possibility that STAT and other studies are being submitted to the FDA for another label change. There does not need to be disclosure of submittal and the FDA limits access to submittals, recognizing that confidentiality may be preferred by companies for valid strategic reasons. Once a label change is approved, however, that becomes a material event which must be filed and a PR would be issued.
MannKind appears to be ahead of the pack in conducting studies of key measurements that go "Beyond A1C". They may want to keep their progress quiet for now until they are able to apply it to their marketing, including new TV and internet ads.
Very advantageous for MNKD to submit to the FDA without risk, "There does not need to be disclosure of submittal and the FDA limits access to submittals..." The risk to the downside in SP is minimized when we don't know what is being done behind the scenes, but the potential for a nice upside is even better if we get surprised positive news from the FDA. Yet, it will still boil down to the doctors embracing Afrezza by prescribing it as a first choice drug and/or in combo with another.
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Post by akemp3000 on Mar 24, 2018 8:02:58 GMT -5
The STAT study results will be presented at the ADA in June by it's source, the University of Colorado. My hope is that Dr. Kendall somehow also gets a microphone, an interview, or publishes some form of white paper article, stating that based on the STAT study results and 5,000 trial patients over many years, Afrezza should now be the initial standard of care for diabetes. He can then explain the reasons in simple terms. While there are marketing restrictions on what can be promoted, Dr. Kendall, as the former Chief Scientific Medical Officer for the ADA, has the industry credibility to share his knowledge and perspective. IMO, if this happens, word will spread among endos and others who never took the time to learn about Afrezza themselves but look to him as an industry leader. They will finally learn about the real Afrezza versus the one bashed by history and competition. This would be an ideal time to simultaneously expand marketing. A label improvement and acceptance for pediatrics should then follow.
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Post by olebob1 on Mar 24, 2018 10:38:35 GMT -5
It is now an EXACT SCIENCE ! AFREZZA.... with the CGM / no excuses ! Lenny: Is this directed at PWD, Endos, general practice MDs, insurance companies, all of the above, or someone else?
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Post by cedafuntennis on Mar 24, 2018 10:51:59 GMT -5
I for one hope you are right and thank God Mike found the lost studies and had the good sense to ask Dr. Kendall to review. The studies were never “lost”, they just weren’t utilized. What was previous managent thinking, ignoring the treasure trove of data they were sitting on? Hopefully there is enough lung safety data to go back to the FDA and eliminate or reduce the clinical safety trial they require.
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Post by lennymnkd on Mar 24, 2018 11:34:55 GMT -5
Being a “little” facetious ... but with that said , ALL OF THE ABOVE !
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Post by sayhey24 on Mar 24, 2018 17:17:18 GMT -5
The studies were never “lost”, they just weren’t utilized. What was previous managent thinking, ignoring the treasure trove of data they were sitting on? Hopefully there is enough lung safety data to go back to the FDA and eliminate or reduce the clinical safety trial they require. The studies were "lost". Sent from Paramus when it was shut down to Danbury in boxes. Mike had no idea they existed. The lung safety study is an interesting one. It came out of a Adcom discussion which focused on Exubera. Pfizer did great job of FUD. It would be nice if Dr. Kendall could get rid of the study just to reduce cost. From a practical matter people have been using afrezza for about 9 years now with no issues. For bragging rights it would be good to do the study as current users are reporting no issues and some say they have not been this healthy in years.
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Post by sportsrancho on Mar 24, 2018 20:08:11 GMT -5
“THE LOST STUDIES” it sounds like a buried treasure movie, with heroes and villains and the fight for truth. And the search for the missing piece, with a team that flies over the the naysayers, in the face of adversity, with the key that unlocks the treasure for all to see! Oh, I guess it is:-)
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Post by brotherm1 on Mar 24, 2018 20:42:22 GMT -5
Wow Sports! Very nice! I never saw the creative side of you before. Your emotional intelligence is clearly brilliant. You’re communication skills are tops. I find you’re array of intelligence very attractive. You can connect quickly with anyone. I sincerely believe Mannkind should beg to hire you to sell Afrezza. Serioulsy. 👍😉
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