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Post by EveningOfTheDay on Dec 15, 2015 18:56:58 GMT -5
Unless there were two simultaneous meetings in SD on the same weekend with the same group of early adopters, this would have to be the same Sanofi gathering.
I agree that the goal of the meeting as expressed by an attending endo sounds very encouraging. Will see.
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Post by slugworth008 on Dec 15, 2015 19:24:14 GMT -5
What continues to distress me - Is that, yet again, we are left to speculate and get information from a participant - And not from SNY directly.
Would it really be that difficult to put out a press release/statement regarding the intent of the San Diego meeting? and perhaps actually having SNY declare some level of happiness with the results of the meeting. From my perspective and given the current action of the PPS this would be in order.
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Post by Deleted on Dec 15, 2015 20:13:32 GMT -5
What continues to distress me - Is that, yet again, we are left to speculate and get information from a participant - And not from SNY directly. Would it really be that difficult to put out a press release/statement regarding the intent of the San Diego meeting? and perhaps actually having SNY declare some level of happiness with the results of the meeting. From my perspective and given the current action of the PPS this would be in order. Why is it that Sam and others had to sign a NDA and these guys write an article about the event? That does not make sense. |
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Post by bill on Dec 15, 2015 20:30:16 GMT -5
Regarding the new Mike Hoskins post in Healthline.com, I think a few things can be inferred from Dr. Jeremy Pettus comments. Of course, goes without saying, even if I do, that as long as this is all a personal opinion, my conclusions might be very different than those of others. Apart from his now well discussed and unfortunate comment comparing dream boat to a crack pipe, the first thing that is clear is that if Mannkind and Sanofy ever thought the drug would sell itself, or with minimal investment in advertising and doctor and patient education, they were drastically wrong. Afrezza will need considerable work if it is to become a successful treatment, and this work that needs to be done will require a considerable investment that, probably, will not see a return in the near term. It is then not too surprising the short side is been speculating Sanofi, which has already plenty of other problems, would drop Afrezza at the first chance they have. It is hard, if not impossible, to credibly analyze the situation without understanding what were Mannkind and Sanofi initial expectations, something that has never been made public, but we do know that both companies have expressed initial disappointment and that, after those comments, little has been said. Is is because the companies are scrambling to find an approach that will provide better results? or, is it because the partnership is seriously strained? It would seem to me somewhat unreasonable that the expectation is that Afrezza, being so different, would take the world by storm right out of the gate; therefore, the idea that Sanofi would abandon ship so early into the introduction of Afrezza seems to me unlikely. However, I do now understand why those on the short side have been increasing their bets until recently and keeping pressure on the sp, especially if they, as it is likely, might have had an inside view on the initial very real disappointment by Sanofi. We also know from this article that the feeling that Sanofi might drop Afrezza is fairly spread, as both the blogger and the Dr. happen to mention this. I do not care much for what the blogger might have to say on the issue, but I certainly care for what a doctor, that apparently was attending the much talked about San Diego meeting with early adopters and that has tried Afrezza himself, might have to say. Many here will call this FUD spreading, but in my opinion we are way past the point were we keep holding to the idea that there is a larger conspiracy theory trying to sink Mannkind. The product has simply not done well, whatever the reasons which could be many and not all Mannkind's fault, and the stock price has reflected this. Nate Pile recently argued that he thought valuation for Mannkind could be in the $8 to $12 range where it not for the very large short position. That is possible, but it is hard to argue with the fact that shorts have done really well here, at least on paper. Another thing that seems clear from the article is that the number of early adopters attending the weekend in San Diego, judging from the picture, is rather small. I had hopes that we were talking about 20 to 30 adopters, but the picture only shows 12, and Dr. Edelman. It could be that there were some that refused to be in the picture, but that was somewhat disappointing as well. I certainly would like to hear from Sanofi or Mannkind how the weekend went, what was learned and how it will shape future strategy, but I am not counting I ever will. And now, back to the shorts, in the last couple of weeks interest paid by those borrowing the stock and paid to those lending the stock has dropped precipitously. My question to the board in general is whether members think that the interest rates coming down is a symptom of shorts starting to cover in large amounts, or simply shorts thinking there no longer is any need to keep pressure on the stock, since tax season and, come January, Sanofi abandoning the project, will take care of any concerns they might have had of not being able to cover at current prices. Basically, are we about to see a turnaround, something I hope for, or final confirmation on how wrong longs were. And if we see a turnaround, what do members think we should expect? Will we quickly climb back into the 4s, 5s and 6s or are we painfully be dragging, as I suspect, in the 2s and perhaps 3s until we see some clarity on Sanofi’s intent and some traction on weekly Rx. Disclamer: I have never shorted MNKD, although I wish I would have been smart enough to do so. I still have a long position, albeit considerably smaller than once was, since if I would have not sold I would be loosing too much for confort. At this point, as I often said if I lose it so be it. I am not too committed to either outcome, but there are too many things I do not completely understand so I do not want to be completely out of it. I am somewhat looking for reasons to buy back in, at this apparently very attractive prices, but at the same time I think, as I have said in the past too, this could be as good as it gets, for quite a while. With much aloha to all. EOD Don't forget, that while it may or may not be challenging to effectively market Afrezza, so far SNY hasn't even tried.
Most PWDs don't even know it exists and many who have run across it are drawing conclusions about dosing and effectiveness absent good information from SNY.
Is it any wonder you see so much confusion from even well-educated individuals (who aren't necessarily well-educated on Afrezza)?
My thoughts are that the vast majority of the people on this board quickly understood how Afrezza works, why it works, how it's different, and how to dose it. What that means to me is that SNY just needs to get it right in the advertising; web, print, radio, TV, social media etc. By now they know all the areas to touch on. The story is not really that hard, it's just not intuitive and people have to trust what they're hearing. None of this is hard it just takes the right campaign with an appropriate amount of funding.
This is not like trying to sell ice cream to Eskimos in the winter, but I do believe that the prescription ramp will not be linear. I suspect there's a tipping point somewhere where once you get to a certain point, the prescriptions will explode. The explosion will occur when SNY can find a way to claim superiority, lower incidents of hypoglycemia, and very low risk of lung issues. And, finally maybe some variety in the Dreamboat colors so they look less like crack pipes  .
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Post by Deleted on Dec 15, 2015 21:09:51 GMT -5
Part of making Afrezza successful is laying the proper foundation. Sanofi kind of came in late to the construction project so some of what they have been doing this year has been neither visible, sexy or driven short term sales. Not defending, but it is what it is. The changing of the CEO and reorg further delayed things. Once Sanofi had an interim CEO, the troops put their heads down and tried to stay off of radar screens and keep their jobs. In this economy, we would do the same so for all the time there was an interim CEO, and until the new CEO revealed his reorganization and strategic plan, Sanofi as it pertains to Afrezza was treading water.
Big marketing campaigns when your drug requires prior authorization, big costs to patient, spirometry not to mention educating doctors who are time constrained and historically resistant to change would have been a waste of money. All this stuff takes time and money to address. Not that we are not in a difficult position because we are.
There is no other diabetes drug that works as well as Afrezza, zip, nada zilch. Using Afrezza results in lower blood glucose levels, more consistent blood glucose levels with less highs and lows which cause much of the long term health complications. Read the warnings on the labels of the oral diabetes meds. Most of this stuff is poison with a few positive side effects.
Big pharma brings a many things to the table include well funded regulatory departments and significant presence and influence in the contracting process with payors.
I think it is significant that CVS Caremark (2nd largest PBM) and Harvard Pilgrim now have Afrezza on the preventative therapy drug list. There are probably more as well and this eliminated the hassles of prior authorization and the big economic hurdle both of which are impediments to Afrezza Rx & sales growth.
Sanofi dropping Afrezza would not be good for us but it appears they have done some heavy lifting in the payor space and have some important trials commencing with a few more key ones completed. If the completed trials have good results, Sanofi walking away after laying this key groundwork would make it that much easier for a successor to come in and accelerate growth. Not sure how wise it would be for them to walk at this point and in fact, with what is happening, a strong sales push and more physician education would accelerate sales growth well beyond what we have seen in 2015.
For those angry at Al, remember that some forces beyond his control have but some significant road blocks in everyones way. Afrezza is that good which is why the fight is that vicious.
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Post by Deleted on Dec 15, 2015 21:58:44 GMT -5
I wonder if there is some sort of clause to get out of contract if there is a restructuring of power at SNY
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Post by sweedee79 on Dec 15, 2015 22:44:45 GMT -5
I just read the article.... Nothing that Mike Hoskins said concerns me... however the following comment concerns me very much.
"I mention this also because there are murmurings about the drug being discontinued in the near future because it is not selling well"
Dr. Jeremy Pettus"
My question is HOW could the drug sell "very well" and be advertised large scale when just about no one has been educated properly on how Afrezza works due to label constraints.... . what happened to the "slow launch" that SNY talked about?? None of this makes any sense ... MNKD knew the label needed to be changed... for one the dosage information in the instruction sheet says Afrezza is the same dose for dose when it isn't... this alone sets Afrezza up to fail with some docs and patients.. learned this first hand..
It just makes me furious... Both SNY and MNKD should have known all of this going in and been prepared for slow uptake in sales due to all of the obstacles that to me were obvious... Otherwise MNKD should not have found a partner and started ANYTHING until they had the label correct so they could actually market it appropriately ..
I don't know... Maybe what Dr. Pettus said means nothing... but he is close to the inside.. Dr. Edelman etc.. so I'm taking this serious...
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Post by Deleted on Dec 16, 2015 4:46:16 GMT -5
Unless there were two simultaneous meetings in SD on the same weekend with the same group of early adopters, this would have to be the same Sanofi gathering. I agree that the goal of the meeting as expressed by an attending endo sounds very encouraging. Will see. This program ran around the same time as the Sanofi program and this event was held at the La Jolla Hyatt. The Sanofi program was in Del Mar 20 min or so north. tcoyd.org/index.php/continuing-medical-education/cme-dinner-sandiego-ca-2015-postp.htmlDrs. Edelman and Pettus are listed as team members of TCOYD tcoyd.org/index.php/tcoyd-team/tcoyd-team.htmlEdelman is an Afrezza fan correct? Here is the link for the diabetes mine article. Sam and others had to sign an NDA. How can diabetes mine talk about the meeting purpose was trial design. Something does not add up www.healthline.com/diabetesmine/afrezza-focus-group-feedback#2"The purpose of the group was to learn how successful Afrezza users use Afrezza successfully (say that 10 times fast!) with the intent of designing a clinical trial around this info. " Does this trial design translate into a few dozen people who have been very successful with Afrezza that will explain dose timing, unit size, follow up dosing along with CGM and A1c data and will it all translate into superiority, ultra rapid acting, lower BG levels, lower A1c and less hypos? If Sanofi and Mannkind believe they can do this trial, and make these label claims by say end of Q2 or Q3 of 2016, then there is no way in hell Sanofi drops Mannkind. With this kind of label, the graph for NRx and TRx will be hockey stick. |
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Post by tayl5 on Dec 16, 2015 4:50:37 GMT -5
What continues to distress me - Is that, yet again, we are left to speculate and get information from a participant - And not from SNY directly. Would it really be that difficult to put out a press release/statement regarding the intent of the San Diego meeting? and perhaps actually having SNY declare some level of happiness with the results of the meeting. From my perspective and given the current action of the PPS this would be in order. Why is it that Sam and others had to sign a NDA and these guys write an article about the event? That does not make sense. Hmmmm, Sanofi employees cannot mention the anecdotal results of individual users without going off-label, but if a blogger happened to be at a meeting of such users and wrote about what he heard, I don't know how the leak could possibly have been prevented... |
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Post by slugworth008 on Dec 16, 2015 6:06:46 GMT -5
What continues to distress me - Is that, yet again, we are left to speculate and get information from a participant - And not from SNY directly. Would it really be that difficult to put out a press release/statement regarding the intent of the San Diego meeting? and perhaps actually having SNY declare some level of happiness with the results of the meeting. From my perspective and given the current action of the PPS this would be in order. Why is it that Sam and others had to sign a NDA and these guys write an article about the event? That does not make sense. An excellent observation. Now where is that PR from SNY? Waiting.... |
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Post by kball on Dec 16, 2015 7:02:20 GMT -5
Unless there were two simultaneous meetings in SD on the same weekend with the same group of early adopters, this would have to be the same Sanofi gathering. I agree that the goal of the meeting as expressed by an attending endo sounds very encouraging. Will see. This program ran around the same time as the Sanofi program and this event was held at the La Jolla Hyatt. The Sanofi program was in Del Mar 20 min or so north. tcoyd.org/index.php/continuing-medical-education/cme-dinner-sandiego-ca-2015-postp.htmlDrs. Edelman and Pettus are listed as team members of TCOYD tcoyd.org/index.php/tcoyd-team/tcoyd-team.html
Edelman is an Afrezza fan correct? Here is the link for the diabetes mine article. Sam and others had to sign an NDA. How can diabetes mine talk about the meeting purpose was trial design. Something does not add up www.healthline.com/diabetesmine/afrezza-focus-group-feedback#2"The purpose of the group was to learn how successful Afrezza users use Afrezza successfully (say that 10 times fast!) with the intent of designing a clinical trial around this info. " Does this trial design translate into a few dozen people who have been very successful with Afrezza that will explain dose timing, unit size, follow up dosing along with CGM and A1c data and will it all translate into superiority, ultra rapid acting, lower BG levels, lower A1c and less hypos? If Sanofi and Mannkind believe they can do this trial, and make these label claims by say end of Q2 or Q3 of 2016, then there is no way in hell Sanofi drops Mannkind. With this kind of label, the graph for NRx and TRx will be hockey stick. More. Remember reading that he also was on it. (If i'm not remembering this correctly, God help me.) |
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Post by kball on Dec 16, 2015 7:09:09 GMT -5
Why is it that Sam and others had to sign a NDA and these guys write an article about the event? That does not make sense. Now where is that PR from SNY? Waiting.... It makes sense to me. Perhaps Sanofi preferred a known Diabetes resource site to aggregate the goings on and tell the story rather than have the participants write whatever they wanted whenever they wanted however they felt like to a much smaller audience? |
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Post by peppy on Dec 16, 2015 7:19:59 GMT -5
Unless there were two simultaneous meetings in SD on the same weekend with the same group of early adopters, this would have to be the same Sanofi gathering. I agree that the goal of the meeting as expressed by an attending endo sounds very encouraging. Will see. This program ran around the same time as the Sanofi program and this event was held at the La Jolla Hyatt. The Sanofi program was in Del Mar 20 min or so north. tcoyd.org/index.php/continuing-medical-education/cme-dinner-sandiego-ca-2015-postp.htmlDrs. Edelman and Pettus are listed as team members of TCOYD tcoyd.org/index.php/tcoyd-team/tcoyd-team.htmlEdelman is an Afrezza fan correct? Here is the link for the diabetes mine article. Sam and others had to sign an NDA. How can diabetes mine talk about the meeting purpose was trial design. Something does not add up
www.healthline.com/diabetesmine/afrezza-focus-group-feedback#2"The purpose of the group was to learn how successful Afrezza users use Afrezza successfully (say that 10 times fast!) with the intent of designing a clinical trial around this info. " Does this trial design translate into a few dozen people who have been very successful with Afrezza that will explain dose timing, unit size, follow up dosing along with CGM and A1c data and will it all translate into superiority, ultra rapid acting, lower BG levels, lower A1c and less hypos? If Sanofi and Mannkind believe they can do this trial, and make these label claims by say end of Q2 or Q3 of 2016, then there is no way in hell Sanofi drops Mannkind. With this kind of label, the graph for NRx and TRx will be hockey stick. A Trojan Horse? |
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Post by bradleysbest on Dec 16, 2015 9:31:45 GMT -5
SNY had to be pleased with this groups success in using Afrezza. Hopefully it translates in to something meaningful regarding trials, etc.... I am sure there are more than these 12 who are equally pleased with their results!
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Post by lfalcon on Dec 16, 2015 9:58:44 GMT -5
Dr Jeremy Pettus: Potential conflict of interest? I don't generally post, but am a staunch MNKD long and Proboards reader. I stumbled on this info from a ST poster, also a long, who has been reliable (opsguy). The following link and story somewhat clarifies Dr. Pettus' confusing stance on Afrezza -- he is working on a stem cell cure for diabetes at UC........also makes one wonder why Hoskins chose him to interview.....on the other hand, even a competitor couldn't deny the outstanding feedback from the early adopters. (hope the link works....don't really know how to do this!) www.wfmz.com/lifestyle/Health-Beat/Health-Beat-Stem-cells-for-diabetes/34253436
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