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Post by dreamboatcruise on May 17, 2018 12:38:26 GMT -5
So they can use the data from these studies even though the FDA issued a CRL denying the same? How many of these studies were done with the medtone inhaler? I personally think the FDA is all wet, but I’m curious if something has changed there to allow this data into the mix? FDA has no jurisdiction over publication of studies. Those studies occurred pre FDA approval and could have been published back then... and they still can be. Even now if MNKD wanted to do a study with the Medtone inhaler they'd be free to do so and publish. The results of those studies can't be used for marketing to consumers as that is under FDA jurisdiction.
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Post by hellodolly on May 17, 2018 12:42:35 GMT -5
So they can use the data from these studies even though the FDA issued a CRL denying the same? How many of these studies were done with the medtone inhaler? I personally think the FDA is all wet, but I’m curious if something has changed there to allow this data into the mix? FDA has no jurisdiction over publication of studies. Those studies occurred pre FDA approval and could have been published back then... and they still can be. Even now if MNKD wanted to do a study with the Medtone inhaler they'd be free to do so and publish. The results of those studies can't be used for marketing to consumers as that is under FDA jurisdiction. Thanks DBC for additional clarification and distinction between the two; marketing and pre-approval studies.
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Post by dreamboatcruise on May 17, 2018 12:50:51 GMT -5
FDA has no jurisdiction over publication of studies. Those studies occurred pre FDA approval and could have been published back then... and they still can be. Even now if MNKD wanted to do a study with the Medtone inhaler they'd be free to do so and publish. The results of those studies can't be used for marketing to consumers as that is under FDA jurisdiction. Thanks DBC for additional clarification and distinction between the two; marketing and pre-approval studies.
Another good example would off label uses. A pharma can do clinical trials for an off label use of a drug and have those results published. They can't have their sales reps marketing off label uses to doctors or do consumer marketing for that indication until after the FDA approves the new indication.
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Post by u1682002 on May 17, 2018 13:08:43 GMT -5
Thanks for the excitement that you guys brought back from this year ASM. WTH, I bought 200 more shares this morning just to celebrate this with you guys!
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Post by bioexec25 on May 17, 2018 13:09:52 GMT -5
Key thoughts and takeaways from the shareholder meeting as I heard them in no particular order. To my colleagues who were there with, please correct or add context to the below:
* Strong and appropriate collaboration between Medical and Commercial. Dr. Kendall drove this approach at Lilly. The great chemistry between David and Mike was apparent. * Having a diabetes thought leader as CMO allows a double-click into all the existing trial data that wasn't possible with the past oncology oriented CMO. * Med affairs team small but focused on exploiting existing data to support awareness and sustainable adoption. * Total publications to date 13, in last 3 months, 14 more publications using the existing data. * Dr. Kendall (med affairs team) will reach out and leverage 10 of the top 30 world renowned thought leaders to map out priorities. * A scientific advisory board will be established to inject critical thinking and drive outcomes for Mannkind. * Runway with little to no competition is approx 10 years based on today's technology and pipelines in diabetes care. Mike and David emphasized nothing even comes close in the mealtime space. * The goal is for Afrezza to become the standard of care for mealtime diabetes therapy within an ultra-rapid classification (alone). * Thought leaders are now calling Mnkd to discuss adoption and some are interested in inclusion of afrezza in studies. * ACE/ADA who's mission is to prevent and cure diabetes and to improve the lives of PWD is in contact with Mannkind (Dr.K) to discuss afrezza and standard of care requirements. * Emphasis was put on not needing any more clinical trials to achieve this goal. Dr. Kendall considers existing data a gold mine. The now infamous veins of gold comments. * Level of talent across the company was impressive. Experts from Lilly have joined David in medical, digital marketing expert from Amgen, new regulatory leader, chief comm officer and others. * Was impressed with the progress in the digital marketing space. Websites launches and transformations, deep analytics on effectiveness, SEO/SEM search and paid search design and execution is beginning. * Progress with the bluehale software application and plans to begin leveraging this (admittedly I did not get program plans for execution). * Late breaking abstracts approved for ADA conference. Dr. Kendall stressed that this is actually an important accomplishment with a high bar. * STAT study could not be discussed per regulations, however David and Mike were buoyant when talking about the goals and how this will be leveraged post ADA. * The Mannkind Cares program (process for questions, on-boarding patients/docs) had been flat, but last two weeks straight up spike in the number of inquires. This process is critical to sustainable on-boarding to avoid dropouts.
Gosh there is probably more and a double-click on some of these needed to drive out context, but that's my list for now. I will add that the new digs look great with room to grow (not paying for that space now). The top team seemed connected and well integrated. Mike was in great form and in command of a very wide range of details internally and externally. Lastly for me there was a resounding confirmation of why Dr. David Kendall came to Mannkind. He sincerely believes in afrezza and it becoming the standard of care and more. The ability to execute on afrezza strategy is fantastic with his medical chops in the diabetes space along with his network connections with world renowned scientists and organizations like the ADA. I have some views on risks or critical success factors and maybe can articulate those at some point.
It was fantastic meeting fellow ProBoard colleagues. Great conversations. Reconciling the avatar/handle with the names and faces was a hoot. The dinner the night before was epic (including Mike's drop by) and our follow-up debrief lunch was awesome. So much diversity of experience and perspective made for substantive discussion. I believe most of us feel the turnaround is now going full speed ahead. Great minds think alike, but of course fools rarely differ. We collectively discussed and offer solutions to many problems, but as I mentioned to barnstormer, often a camel is a horse designed by committee.
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Post by sirlurkalot on May 17, 2018 13:32:29 GMT -5
Completely agree, but they were issued a CRL based on the bridge study. I just wonder if there’s been a change at the FDA. Or there is a lower bar for using study data than there is for approval/label. They did reject the first bridge study, however they did a second one(171) after the second CRL. And that one was approved. "“We are pleased that Study 171 met its primary endpoint of non-inferiority, by demonstrating that Afrezza produces A1c reductions comparable to insulin aspart,” stated Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. “Importantly, this study also established a bridge between the Gen2 inhaler and the large body of pulmonary safety data that was previously collected for Afrezza using the MedTone inhaler." www.drugs.com/nda/afrezza_130814.htmlAfrezza approval history www.drugs.com/history/afrezza.htmlIIRC, The bridge study data was not the reason for the CRL. It was issued because, despite earlier indications from discussions with the FDA, the bridge study could not be used due to FDA rules; IMHO, the rule would have been overlooked or discounted per the prior discussions (recall the FDA insider's trading activity?). The rule was brought to the attention of the FDA by MS. Rules are rules, so... But there's no use crying over spilt liquid under the bridge. And MS is in jail if that helps one feel a little better (it does me). Looking forward offers a better view. As DBC noted, the FDA doesn't control study publication or distribution. They constrain labeling. Perhaps publications well-received by KOLs will help with updates to labeling and insurance coverage. Hmmm... Thanks to all ASM attendees and intrepid reporters. The view ahead is looking better and better.
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Post by joeypotsandpans on May 17, 2018 13:40:35 GMT -5
I went into this year’s ASM... Upon arriving, I could see that MannKind staff was ready to have guests. There was a nice assortment of refreshments including pastries for shareholders. ... Final thoughts, MannKind management has a ton of confidence, excitement and energy. It really showed at the Annual Shareholders Meeting. The teamwork and comradery on the executive team was palpable. They are ready to “rock and roll.” I think I win. Wrong!, we (PWD and those long) win in the end was my takeaway from the last 48hrs. ....drove to Cali, went to dinner, ended up sleeping about 4hrs. went to SH meeting, drove straight back to Vegas straight to Golden Knights game for a phenomenal win...if it weren't for Afrezza not sure I would have had the energy to twirl the "battle towel" they gave out for the entire game So other than the previous comments I made from the parking lot before heading back just a couple of remaining thoughts to what most have summarized already, One additional thing I wanted to mention regarding the vote for the additional 3 million shares to be used for employee incentive stock plan, from what I recall Mike mentioned that about 60% of employees have opted into the plan and how extremely high that was relative to what is typical. If I didn't catch that correctly then one of the others that attended can correct. I thought that was a very nice vote of confidence of the non-management staff as well. Along with that, evidently a lot of current employees have been recommending to their qualified networks the opportunities regarding any job openings. Mike stressed the point of having some excellent talent joining the company in today's current tight job market environment. I would also add that in a very tactful way he answered a question the evening of the dinner I presented regarding if previous management were more akin to a ship that was adrift without direction. His response is pretty much what most of us already know, Al was a genius with respect to the science and engineering aspects and that is evident not only in what Afrezza and technosphere bring to society but also in the extensive patents that were put in place. However, promotion and marketing were another story, the assumption of having the best insulin on the market would sell itself was a bit naive (my words not Mikes) especially with the management change at Sanofi (prior Pfizer executive that was in charge originally with Exubera) creating a perfect storm for the unsuccessful launch that took hold. Another takeaway is that Mike reiterated his confidence in meeting guidance and stated such in particular. Also, for those that think they would sell off Afrezza to further develop the company in other directions my takeaway was the exact opposite, that being that Afrezza is MNKD's flagship product and will remain so and that if anything the other products etc. would be more susceptible to getting sold to partners etc. again that is the way I interpreted what I heard. The other take I got regarding Kendall and others leaving Lilly was also more of them not wanting to reinvent a wheel that wouldn't be feasible regarding what already exists to be a new standard of care for mealtime insulin. There are a lot of FUD articles written and those that have predicted the demise of this company and continue to predict it years later.....the little engine that could is about to finish it's uphill climb IMO and move on to cruising on it's own. Mike cannot redo the past, however he can and has taken the bull by the horns (tremendous kudos regarding reaching out to David Kendall and having the vision and confidence to do so) and with his previous experience of turnaround situations in his prior positions help Afrezza and Technosphere realize their fullest potential. Mike and the company will continue to have my full support both as a patient, patient advocate, as well as an investor with strong conviction, GO KNIGHTS GO!! Vegas Strong/MNKD Long and Strong
Excellent recaps by those others that attended really couldn't add much else without being redundant. Thank you all for your time and perspectives, great meeting you all finally!
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Post by brentie on May 17, 2018 13:41:51 GMT -5
They did reject the first bridge study, however they did a second one(171) after the second CRL. And that one was approved. "“We are pleased that Study 171 met its primary endpoint of non-inferiority, by demonstrating that Afrezza produces A1c reductions comparable to insulin aspart,” stated Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. “Importantly, this study also established a bridge between the Gen2 inhaler and the large body of pulmonary safety data that was previously collected for Afrezza using the MedTone inhaler." www.drugs.com/nda/afrezza_130814.htmlAfrezza approval history www.drugs.com/history/afrezza.htmlIIRC, The bridge study data was not the reason for the CRL. It was issued because, despite earlier indications from discussions with the FDA, the bridge study could not be used due to FDA rules; IMHO, the rule would have been overlooked or discounted per the prior discussions (recall the FDA insider's trading activity?). The rule was brought to the attention of the FDA by MS. Rules are rules, so... But there's no use crying over spilt liquid under the bridge. And MS is in jail if that helps one feel a little better (it does me). Looking forward offers a better view. As DBC noted, the FDA doesn't control study publication or distribution. They constrain labeling. Perhaps publications well-received by KOLs will help with updates to labeling and insurance coverage. Hmmm... Thanks to all ASM attendees and intrepid reporters. The view ahead is looking better and better. "The principal issue raised by the FDA concerned the usage of in vitro performance data and clinical pharmacology data to bridge MannKind's next-generation inhaler to the phase 3 trials conducted using its MedTone inhaler. The FDA has requested that MannKind conduct two clinical trials with the next-generation inhaler (one in patients with type 1 diabetes and one in patients with type 2 diabetes), with at least one trial including a treatment group using the MedTone inhaler in order to obtain a head-to-head comparison of the data for the two devices. In the complete response letter, the FDA stated that after an adequate titration of study medication there should be at least twelve weeks of relatively stable insulin dosing at the end of the treatment period." www.drugs.com/nda/afrezza_110120.html
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Post by centralcoastinvestor on May 17, 2018 14:01:21 GMT -5
Something I neglected to say in my summary is how much I enjoyed meeting some of the real people behind all of the great posts on ProBoards. We commented on how diverse a group we were and are. I think everyone reading our summaries can see how each of us picked up something different as to what was important. Not to get too sentimental, but I have learned so much from participating on this Board. Regardless of the ultimate outcome for MannKind, it has and continues to be a pleasure being a part of this crazy group of investors.
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Post by sportsrancho on May 17, 2018 14:10:48 GMT -5
Joey...agree. Another takeaway is that Mike reiterated his confidence in meeting guidance and stated such in particular. Also, for those that think they would sell off Afrezza to further develop the company in other directions my takeaway was the exact opposite, that being that Afrezza is MNKD's flagship product!!!
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Post by lojothehus on May 17, 2018 14:17:19 GMT -5
Something I neglected to say in my summary is how much I enjoyed meeting some of the real people behind all of the great posts on ProBoards. We commented on how diverse a group we were and are. I think everyone reading our summaries can see how each of us picked up something different as to what was important. Not to get too sentimental, but I have learned so much from participating on this Board. Regardless of the ultimate outcome for MannKind, it has and continues to be a pleasure being a part of this crazy group of investors. I agree, great board to be a part of!
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Post by novafett on May 17, 2018 14:18:55 GMT -5
Where are the group photos?
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Post by bradleysbest on May 17, 2018 15:02:08 GMT -5
CCI, Barnstormer, Joey & Bioexec have all summed up the meeting accurately. The leadership team is building the foundation for Afrezza to succeed & maintain itself once it becomes the standard of care. Mike referred to building Afrezza from the inside out. It appears both Mike & David have the smarts, passion & work ethic to see Afrezza succeed. Like most I have lost a bunch of money in MNKD but feel much better about getting my “paper” loss back. These 2 are surrounding themselves with talent and will dig in to to get the job done. My feeling is if these 2 can’t get Afrezza going, no one can. I look forward to where things stand next year at this time. GLTA
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Post by sportsrancho on May 17, 2018 15:03:42 GMT -5
Where are the group photos? Lakers asked me that too and I never got back to him. Barnstormer/Bioexec25/Centralcoastinvestor/ Joey/ Tom my friend and client. His son Jake( First kid on Afrezza) Tom and Jake got to spend time with Mike after the meeting.) K-ball/ Uvula. And Baba.. The very tall good looking one! Coco, myself , Denise and her brother. Mannmade. Not in that order...
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Post by ilovekauai on May 17, 2018 15:13:39 GMT -5
I did ask the question that Peppy wanted. With STAT coming out next month, and no lows, will this finally move the needle on: A). Doctors B). Improved insurance coverage. Kendall answered and said the STAT coming out can do a lot, but it was a small study of only 60 participants, so there's that. I can't recall if if he answered the part of insurance coverage, but then Kendall reemphasized how how the STAT is something he can work with in many other arenas, in addition to the ADA meeting next month and I believe him. He seemed to relish the anwwer Peppy. Thank you for providing that.
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