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Post by mnholdem on Dec 22, 2015 9:14:07 GMT -5
Occasionally, I receive PM's asking my opinion on various topics. In more cases than not, I suggest that the inquiring Pro-Board member take some time to read past transcripts:
Link: www.nasdaq.com/symbol/mnkd/call-transcripts
Often information that has been publicly provided by MannKind/Sanofi gets glossed over or is simply forgotten over time. I wish I had taken the time to formulate a sort of "Calendar of Events" talked about during management conferences. Perhaps after the holidays I will undertake that project. While information has been scant (that's an understatement) nonetheless it would be nice to have a timeline posted here that lists those events for which management has disclosed a rudimentary schedule.
Lately there have been a number of challenges for Sanofi to better demonstrate its support of Afrezza. One argument that gets posted time and again is that if Sanofi were fully behind this agreement, they would have started the expensive 5-year pulmonary safety study, which is a postmarket study required by the FDA to study the long-term effects on the lungs from inhaling insulin. In some investors' minds, this would demonstrate Sanofi's financial commitment to Afrezza.
Some have asked, "Why hasn't MannKind told us when/if Sanofi will begin recruitment for this trial?"
The answer is: They have!
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Q2 2015 Earnings Conference Call - August 10, 2015
Hakan Edstrom:
"The protocol for the fourth and final study on the five-year pulmonary safety received comments and recommendations back on the FDA in July, which are now being reviewed by the joint Sanofi and MannKind clinical team. Discussions are expected to be held with the reviewing division of the FDA to further clarify their recommendations and provide our comments back. That study is planned to begin in early 2016. So, in summary, we are pleased to note that the strong progress has been made in meeting the FDA post-marketing study requirements for Afrezza and we note that Sanofi continues to support the partnership by coordinating and leading all efforts in this key ongoing activity."
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During this apparent "quiet time" that is being imposed upon us by MannKind and its partner, it becomes so easy to speculate (which can be either exciting or depressing) or to read others' speculation - for better or worse - of what has happened, is happening and may happen in the weeks/months/years ahead.
I suggest that you take all speculation with a grain of salt and focus on the information that has been provided to date by MannKind and Sanofi. It may not be as much information as I want as an investor, but I think that it would be irresponsible, if not stupid, to ignore what I've been told so far. The information I posted (above) is one of many examples of credible information that gets glossed over by a lot of irrelevant information. Don't take my word for it. Check it out yourselves.
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I have made many new friends here in 2015. I wish to extend to all of you my humble prayer that you will have a safe & happy holiday season, followed by a very prosperous new year!
Good fortune all.
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Post by factspls88 on Dec 22, 2015 9:30:37 GMT -5
Thanks mnholdem for reminding us of the comments made regarding the pulmonary study. I think your calendar idea is a good one. It might also make sense to create a status report that breaks information out by category and date, and keeps a running update as information is dispersed. For example, there would be a status category for the 5 year pulmonary study, the Pediatric Study, Advertising, Promotional Programs, Technosphere Partnership, etc. etc.
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Post by kball on Dec 22, 2015 9:38:20 GMT -5
And a quick thank you here to lakers, saxcmann and docfrezza (along with several others) for posting reliable insight from deep inside the cauldron
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Post by esstan2001 on Dec 22, 2015 9:45:06 GMT -5
I have made many new friends here in 2015. I wish to extend to all of you my humble prayer that you will have a safe & happy holiday season, followed by a very prosperous new year!
Good fortune all.
Thank you for the excellent job you do in moderating here, and for bringing clear, pertinent information to the members of this board; You, Liane, and BD truly make this THE place to come regarding all things Mannkind. To all the moderators and long time members, and even the new ones- a Happy, Healthy Holiday and a Prosperous New Year! |
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Post by mssciguy on Dec 22, 2015 9:52:38 GMT -5
I have made many new friends here in 2015. I wish to extend to all of you my humble prayer that you will have a safe & happy holiday season, followed by a very prosperous new year!
Good fortune all.
Thank you for the excellent job you do in moderating here, and for bringing clear, pertinent information to the members of this board; You, Liane, and BD truly make this THE place to come regarding all things Mannkind. To all the moderators and long time members, and even the new ones- a Happy, Healthy Holiday and a Prosperous New Year! Yes thanks to the mods and admins but let's not forget also ripano thanks and happy and safe holidays prntscr.com/9h8if6 |
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Post by tommix321 on Dec 22, 2015 12:13:18 GMT -5
Occasionally, I receive PM's asking my opinion on various topics. In more cases than not, I suggest that the inquiring Pro-Board member take some time to read past transcripts:
Link: www.nasdaq.com/symbol/mnkd/call-transcripts
Often information that has been publicly provided by MannKind/Sanofi gets glossed over or is simply forgotten over time. I wish I had taken the time to formulate a sort of "Calendar of Events" talked about during management conferences. Perhaps after the holidays I will undertake that project. While information has been scant (that's an understatement) nonetheless it would be nice to have a timeline posted here that lists those events for which management has disclosed a rudimentary schedule.
Lately there have been a number of challenges for Sanofi to better demonstrate its support of Afrezza. One argument that gets posted time and again is that if Sanofi were fully behind this agreement, they would have started the expensive 5-year pulmonary safety study, which is a postmarket study required by the FDA to study the long-term effects on the lungs from inhaling insulin. In some investors' minds, this would demonstrate Sanofi's financial commitment to Afrezza.
Some have asked, "Why hasn't MannKind told us when/if Sanofi will begin recruitment for this trial?"
The answer is: They have!
---
Q2 2015 Earnings Conference Call - August 10, 2015
Hakan Edstrom:
"The protocol for the fourth and final study on the five-year pulmonary safety received comments and recommendations back on the FDA in July, which are now being reviewed by the joint Sanofi and MannKind clinical team. Discussions are expected to be held with the reviewing division of the FDA to further clarify their recommendations and provide our comments back. That study is planned to begin in early 2016. So, in summary, we are pleased to note that the strong progress has been made in meeting the FDA post-marketing study requirements for Afrezza and we note that Sanofi continues to support the partnership by coordinating and leading all efforts in this key ongoing activity."
---
During this apparent "quiet time" that is being imposed upon us by MannKind and its partner, it becomes so easy to speculate (which can be either exciting or depressing) or to read others' speculation - for better or worse - of what has happened, is happening and may happen in the weeks/months/years ahead.
I suggest that you take all speculation with a grain of salt and focus on the information that has been provided to date by MannKind and Sanofi. It may not be as much information as I want as an investor, but I think that it would be irresponsible, if not stupid, to ignore what I've been told so far. The information I posted (above) is one of many examples of credible information that gets glossed over by a lot of irrelevant information. Don't take my word for it. Check it out yourselves.
---
I have made many new friends here in 2015. I wish to extend to all of you my humble prayer that you will have a safe & happy holiday season, followed by a very prosperous new year!
Good fortune all.
"That study is planned..." I will be more satisfied once I see it listed on the clinicaltrials website. |
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Post by Deleted on Dec 22, 2015 14:18:32 GMT -5
From the 3Q conference call:
"The last of the post marketing requirement study is the long-term pulmonary safety study, a five-year randomized control trial in 8000 patients with diabetes mellitus to assess pulmonary safety of Afrezza compared to the standard of care. The Sanofi/MannKind clinical team is currently reviewing the scope and the sign of this study with the FDA, including specifics of the patient population, and study endpoints. The final milestone for a final agreed-upon protocol is April 30, 2016"
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Post by lakers on Dec 23, 2015 3:12:03 GMT -5
Current Status Delayed Explanation of Status The protocol finalization date, April 2015, was missed due to ongoing discussions with the Agency. The applicant proposed a revised protocol finalization milestone of April 2016. FDA determined that the applicant had good cause for their failure to comply with the milestones of the original timetable and acknowledged the revised milestones in a letter dated September 29, 2015. www.accessdata.fda.gov/scripts/cder/pmc/index.cfm |
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Post by mnholdem on Dec 23, 2015 8:34:40 GMT -5
Thanks, guys, for the additional info. The FDA isn't always the quickest at updating their site (one of many that I bookmarked and check up on regularly) but once they did post the update, it confirmed management's comments about the status of 5-year trial that will involve between 8,000 and 10,000 patients.
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Post by prosper on Dec 23, 2015 8:39:39 GMT -5
Great idea, but I wonder if Matt would be willing to share what I am sure he already has charted. Might be worth an ask
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