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Post by mnholdem on Oct 18, 2015 17:44:02 GMT -5
When Matt Pfeffer turned the 1st Quarter earnings conference call over to Al Mann, these were Al's first statements (note that SA may have transcript errors):
"Thank you, Matt. After approval of Afrezza by the FDA on June 27, we've been preparing for the launch. In September, we finalized a partnership agreement with Sanofi, who will provide the commercialization with sales and marketing, and also responsible for further clinic and regulatory activities, and that launch was initiated in February."
This next statement of Al's is what I find to be quite interesting:
"We are getting reports, post-approval Sanofi results and early use of Afrezza that we like to share with you, but it is too soon to have publication of any such reports and peer review journal. Therefore, all we have at this time must be considered anecdotal and cannot be presented in the earnings call."
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Perhaps more than anybody at MannKind Corporation, Al Mann would have inside knowledge of Sanofi's strategy concerning Afrezza. So what does it mean when he states, "it is too soon to have publication of such reports". What reports, what post-approval Sanofi results is he talking about?
There are two questions I have that, in my opinion, haven't been thoroughly discussed in terms of feasibility.
1. Is it likely that Sanofi has been gathering patient data (this is allowed by HIPPA) from early prescribers for a peer review publication in a medical journal, and;
2. Is it mandated that such studies must be registered with the FDA before they commence?
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This is not a shameless pump or speculation. Rather, I am making an honest inquiry. To date, we've only seen peer reviews of Afrezza Phase III trial results. Is it common after a drug launches for studies to be conducted by physicians, universities and BP which are outside the oversight of the FDA, but which can have an affect on prescriber adoption?
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Post by mssciguy on Oct 18, 2015 18:19:09 GMT -5
mnholdem No doubt Sanofi is scrutinizing whatever information is available. Time will tell and the time is approaching ;-) What's amusing to me personally is that in my last professional position the term "suspense " was used for "anticipated completion/soft target goal date" and made zero sense to me at the time, but with MNKD/SNY and Afrezza the term Suspense deserves to be capitalized (and in my view may lie in Nov/Dec/Jan).
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Post by peppy on Oct 18, 2015 20:04:21 GMT -5
Al had a few paragraphs of comments.
seekingalpha.com/article/3161476-mannkinds-mnkd-ceo-hakan-edstrom-on-q1-2015-results-earnings-call-transcript?page=3
regarding this statement in the first post of the thread,
This next statement of Al's is what I find to be quite interesting:
"We are getting reports, post-approval Sanofi results and early use of Afrezza that we like to share with you, but it is too soon to have publication of any such reports and peer review journal. Therefore, all we have at this time must be considered anecdotal and cannot be presented in the earnings call."
All I can come up with is meta analysis. It is highly regarded as evidence. Look at the evidence level.
screencast.com/t/JaOB8P6FzjJz
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Post by mnholdem on Oct 18, 2015 20:47:21 GMT -5
Peppy - The meta analysis that was recently published was a synopsis of the Phase III trial results that I mentioned above. I'm asking about the possibilities of what information Sanofi may be gathering since Afrezza launched. I'm also a little confused as to how your "on a different note" information relates to the questions I'm asking about Afrezza.
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Post by peppy on Oct 18, 2015 20:56:08 GMT -5
Peppy - The meta analysis that was recently published was a synopsis of the Phase III trial results that I mentioned above. I'm asking about the possibilities of what information Sanofi may be gathering since Afrezza launched. I'm also a little confused as to how your "on a different note" information relates to the questions I'm asking about Afrezza. Sorry MN, meta analysis, I think I read at some point meta analysis can include what the physicians are seeing in the clinical setting.
On a different note does not relate to the question you are asking. Looking at the possibilities here is very interesting. Price does not reflect the possibilities of technosphere.
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Post by rrtzmd on Oct 18, 2015 21:16:10 GMT -5
When Matt Pfeffer turned the 1st Quarter earnings conference call over to Al Mann, these were Al's first statements (note that SA may have transcript errors): "Thank you, Matt. After approval of Afrezza by the FDA on June 27, we've been preparing for the launch. In September, we finalized a partnership agreement with Sanofi, who will provide the commercialization with sales and marketing, and also responsible for further clinic and regulatory activities, and that launch was initiated in February."This next statement of Al's is what I find to be quite interesting: "We are getting reports, post-approval Sanofi results and early use of Afrezza that we like to share with you, but it is too soon to have publication of any such reports and peer review journal. Therefore, all we have at this time must be considered anecdotal and cannot be presented in the earnings call."
----- Perhaps more than anybody at MannKind Corporation, Al Mann would have inside knowledge of Sanofi's strategy concerning Afrezza. So what does it mean when he states, "it is too soon to have publication of such reports". What reports, what post-approval Sanofi results is he talking about? There are two questions I have that, in my opinion, haven't been thoroughly discussed in terms of feasibility. 1. Is it likely that Sanofi has been gathering patient data (this is allowed by HIPPA) from early prescribers for a peer review publication in a medical journal, and; 2. Is it mandated that such studies must be registered with the FDA before they commence? ----- This is not a shameless pump or speculation. Rather, I am making an honest inquiry. To date, we've only seen peer reviews of Afrezza Phase III trial results. Is it common after a drug launches for studies to be conducted by physicians, universities and BP which are outside the oversight of the FDA, but which can have an affect on prescriber adoption? Certainly, SNY can collect data from pretty much any source they wish as long as HIPPA guidelines aren't violated, and they are also free to publish pretty much anything anywhere. More relevant is whether any publication short of one clearly demonstrating afrezza is superior to lispro would be of any value at this point. Right now, afrezza needs third party payors, and they, in turn, "need" hard data such as that provided by clinical trials. Long term, user and physician experience might have an impact on their decisions, but the short term needs a high quality trial. |
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Post by ezrasfund on Oct 18, 2015 21:46:08 GMT -5
I asked Hakan about this after the ASM in Danbury this spring, that is whether MNKD and SNY would collect the aggregate results of HbA1c improvements from early Afrezza users and publish them. While he acknowledged that this could be done, and it certainly is something that MNKD has considered, he did not seem eager to discuss the idea. I like to think this is because he did not want to tip his hand, rather than that he did not consider it a feasible idea. His only reply was "We certainly could do that."
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Post by cathode on Oct 18, 2015 23:06:16 GMT -5
I asked Hakan about this after the ASM in Danbury this spring, that is whether MNKD and SNY would collect the aggregate results of HbA1c improvements from early Afrezza users and publish them. While he acknowledged that this could be done, and it certainly is something that MNKD has considered, he did not seem eager to discuss the idea. I like to think this is because he did not want to tip his hand, rather than that he did not consider it a feasible idea. His only reply was "We certainly could do that." That is potentially very promising news. There had been a little discussion on this board, I believe, on why Sam Finta has stopped posting the group results. Some thought that it might be at the request of Sanofi/MannKind, who were looking to capitalize on these great results from the early adopters. |
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Post by mbseeking on Oct 19, 2015 0:44:24 GMT -5
When Matt Pfeffer turned the 1st Quarter earnings conference call over to Al Mann, these were Al's first statements (note that SA may have transcript errors): "Thank you, Matt. After approval of Afrezza by the FDA on June 27, we've been preparing for the launch. In September, we finalized a partnership agreement with Sanofi, who will provide the commercialization with sales and marketing, and also responsible for further clinic and regulatory activities, and that launch was initiated in February."This next statement of Al's is what I find to be quite interesting: "We are getting reports, post-approval Sanofi results and early use of Afrezza that we like to share with you, but it is too soon to have publication of any such reports and peer review journal. Therefore, all we have at this time must be considered anecdotal and cannot be presented in the earnings call."
----- Perhaps more than anybody at MannKind Corporation, Al Mann would have inside knowledge of Sanofi's strategy concerning Afrezza. So what does it mean when he states, "it is too soon to have publication of such reports". What reports, what post-approval Sanofi results is he talking about? There are two questions I have that, in my opinion, haven't been thoroughly discussed in terms of feasibility. 1. Is it likely that Sanofi has been gathering patient data (this is allowed by HIPPA) from early prescribers for a peer review publication in a medical journal, and; 2. Is it mandated that such studies must be registered with the FDA before they commence? ----- This is not a shameless pump or speculation. Rather, I am making an honest inquiry. To date, we've only seen peer reviews of Afrezza Phase III trial results. Is it common after a drug launches for studies to be conducted by physicians, universities and BP which are outside the oversight of the FDA, but which can have an affect on prescriber adoption? Certainly, SNY can collect data from pretty much any source they wish as long as HIPPA guidelines aren't violated, and they are also free to publish pretty much anything anywhere. More relevant is whether any publication short of one clearly demonstrating afrezza is superior to lispro would be of any value at this point. Right now, afrezza needs third party payors, and they, in turn, "need" hard data such as that provided by clinical trials. Long term, user and physician experience might have an impact on their decisions, but the short term needs a high quality trial. Stupid, wild , late night Sunday, thought. Could the investors crowdsource such a suitable trial? Raise enough money.. then have it done in the field via a university to prove just this - afrezza is better then lispro (on its own or in tandem with basal). Apple just announce ResearchKit which would allow a large , widespread study to be set up fairly economically I would have thought. We pony up the money.. I'm sure we could find a uni that would appropriately structure a study. |
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Post by cathode on Oct 19, 2015 8:01:52 GMT -5
That is a little too wild for me. Part of the deal is that Sanofi does the trials. This means funding them too... I don't think anyone would appreciate rogue investors trying to get the jump on results. In the academic world there is a highly frowned upon practice called scooping, which is basically publishing results before the real researchers who did the work publish them. In fields that are so reliant on industry for funding, I think any University researchers you approach would be super hesitant to play ball.
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Post by Chris-C on Oct 19, 2015 8:50:55 GMT -5
That is a little too wild for me. Part of the deal is that Sanofi does the trials. This means funding them too... I don't think anyone would appreciate rogue investors trying to get the jump on results. In the academic world there is a highly frowned upon practice called scooping, which is basically publishing results before the real researchers who did the work publish them. In fields that are so reliant on industry for funding, I think any University researchers you approach would be super hesitant to play ball. in my years as an active scientist, I have yet to see a published meta-analysis that included any data (in its statistical analysis) from anecdotal reports, which would mean that data would be gathered under varying conditions with virtually none of the controls customarily required in empirical research. There are multi-site clinical trials, but the protocols for these typically require that data are gathered under highly specified conditions using well trained investigators at each site. These studies are VERY expensive and require great time and effort to organize. It's conceivable that SNY/MNKD could put together a provider database inviting prescribing physicians to contribute clinical information voluntarily for their own (SNY's) internal purposes, but none of these data, would be considered adequate by the FDA to justify label changes. In due course, clinical investigations carried out by Sanofi to meet post approval requirements will be submitted to the FDA, and as appropriate, published later by the scientists involved. If the results are favorable, you can bet that SNY and MNKD will announce this to shareholders and the public. ChrisC |
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Post by mssciguy on Oct 19, 2015 8:57:31 GMT -5
That is a little too wild for me. Part of the deal is that Sanofi does the trials. This means funding them too... I don't think anyone would appreciate rogue investors trying to get the jump on results. In the academic world there is a highly frowned upon practice called scooping, which is basically publishing results before the real researchers who did the work publish them. In fields that are so reliant on industry for funding, I think any University researchers you approach would be super hesitant to play ball. in my years as an active scientist, I have yet to see a published meta-analysis that included any data (in its statistical analysis) from anecdotal reports, which would mean that data would be gathered under varying conditions with virtually none of the controls customarily required in empirical research. There are multi-site clinical trials, but the protocols for these typically require that data are gathered under highly specified conditions using well trained investigators at each site. These studies are VERY expensive and require great time and effort to organize. It's conceivable that SNY/MNKD could put together a provider database inviting prescribing physicians to contribute clinical information voluntarily for their own (SNY's) internal purposes, but none of these data, would be considered adequate by the FDA to justify label changes. In due course, clinical investigations carried out by Sanofi to meet post approval requirements will be submitted to the FDA, and as appropriate, published later by the scientists involved. If the results are favorable, you can bet that SNY and MNKD will announce this to shareholders and the public. ChrisC Great point. Big data meets electronic medical records! This after all is one way that dangerous side effects are detected post-approval, and the more that I learn about the orals, the worse they look. Afrezza on the other hand may offer huge incentives to minimize side effects, while improving longevity and quality of life, and potentially drastically reducing long-term costs to the health care system. |
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Post by suebeeee1 on Oct 19, 2015 9:20:53 GMT -5
Are we really parsing words that were spoken 6 months ago for which there has been no follow up at all? We are REALLY getting desperate! There have been so many statements made that did not pan out (such as the quarter over quarter promises where we have been told that the next choices for Technosphere drugs are being chosen).
Studies take time. I don't know what the requirements are for European and Asian scientific publications, but ancetodatal stories tend to be laughed out of every American professional organization. I don't think Al or Matt or Hakaan would subject themselves to that kind of non-empirical research.
We will have our studies....not today.
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Post by mnholdem on Oct 19, 2015 10:01:23 GMT -5
You're right, suebeeee1. I am resurrecting an old subject, although I don't see it as desperation, per se.
I simply have been reflecting on Sanofi's insistence of keeping their strategy quiet "for competitive reasons" as Pierre Chancel, Sanofi Senior Vice President Diabetes Division, has been quoted as saying in the past and find myself wondering if Sanofi or other pharmaceutical companies have ever conducted post-market studies that are kept quiet so that the competition is kept in the dark.
Ideas spoken 6 months ago for thich there has been "no follow up at all" would be immediately dispelled by a single peer review, published to analyze Afrezza's post-market patient results. That said, I think that Chris' explanation answers one of my questions by indicating that it is NOT likely that Sanofi has been gathering patient data for 8 months, because it would unfortunately be considered anecdotal by the FDA or the medical community.
The answer helps bolster my growing suspicion that I won't be retiring any time soon, although I will continue to acquire shares of MNKD.
I still find Al's remarks that "We are getting reports of... early use of Afrezza that we like to share with you, but it is too soon to have publication of any such reports" to be an unusual way to put it. Shortly after making these remarks, Al resigned from the CEO spot and he has maintained silence since. I find that to be very unusual and, frankly, completely out of character, for Al to keep quiet for this long. 
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