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Post by gomnkd on Feb 7, 2015 23:47:48 GMT -5
gomnkd, I understand and respect what you are saying above, however I am a Long investor and am so because i also think we have the benefit of hindsight on our side (as I believe someone else already pointed out) not to mention a much better science behind us... And so it leads me to believe that many of the analysts simply don't understand the science well enough and that is what makes Afrezza truly different. And if they do understand the science then they have a different agenda or perhaps as you say are still not able to see past yesterday's news... I agree on the better science. Here in lies the greatest ironies. MNKD has nothing to show for it in label with the way the trials were designed. The experience of "Afrezzausers" don't get reflected in trial outcomes & label. The docs therefore are going to start Afrezza for patients who are non-compliant, needle phobic etc (aka doc bottleneck). This is catch-22. We need more evangelists like Afrezzauser to spread the message, but these pts need doc prescription. The doc bottleneck will limit usage and number of evangelists. We need time for virtuous cycle to accelerate. You can't have a blockbuster status with wimpy patients alone. What gives me hope is the feedback from ex-Exubera users. afresa.blogspot.in/2010/02/feedback-from-real-exubera-users.htmlI don't make $ off my blog, so I presume admins are ok with the link. [Totally OK! -BD]
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Post by jpg on Feb 8, 2015 0:45:10 GMT -5
dbc, I think (well hope at least) we will blow the Exhubera numbers away in the first 3 months ... After all 12m in sales after 9 months? However, I personally would not be to quick to expect Afrezza's initial script nor revenue numbers to compare favorably to Humalog and Novolog as both imho were more like "brand extensions," if you will, of already well known products and acceptable therapies. I think Afrezza will be a blockbuster but may take time as it really is a paradigm shift. I say a Paradigm shift, because of the following: 1.) I personally believe at some point, it will become as Al has often said and some articles are now mentioning the first script for a T2 for diabetes treatment and likely jump over if you will Metforman and other GLP-1's. And possibly replace basal insulin as the first insulin therapy T2's are introduced too. 2.) I think (imho and I am not a doctor nor a scientist) there is some credence to the theory that the early introduction of insulin can help save the beta insulin producing cells of the pancreas and thereby limit the duration and/or levels of outside insulin use required for continued maintenance, thereby reinforcing the argument for #1 above. 3.) if the above theories start to prove out, then the last part of my belief and hope is that Endos and GP's will realize as some are starting to hint at, that Afrezza may eliminate the need for use of Basal with Prandial in many patients and/or those that remain on both Basal and Prandial can increase the dosing of Basal to lower FG to near normal levels and thus greatly slow or even stop the progression of the disease which may also occur as suggested by some. (Afrezzauser has already shown with his iniital charts what a CGM and Afrezza can do for T1's. He is claiming to be living a normal life no matter how many carbs he eats. This will of course take a few years of proper study by Sanofi to confirm but as early anecdotal evidence of Afrezza's potential it is very encouraging) Now I don't mean to state any of the above as fact nor am I suggesting it will happen tomorrow. I am talking about a glacial pace for the paradigm shift it will take to change the current conventional thinking, perhaps 5 years... however, this is where the promise of Afrezza lies for me. If I am wrong I think it will still do relatively well over time. These are my long term beliefs about the promise of what is Afrezza and why Al Man spent 14 years and 1.2B of his personal fortune to get us where we are today... The above has nothing to do with what I personally expect the short term or mid term performance of the stock to be as i do expect the numbers to grow slowly, if not methodically, in line with the growth of the introduction of a product that has the potential to "change the game as it is currently played." And diabetics will be rightly justified to take a vey careful and well thought out approach to deciding if it is right for them. So nice that someone with reasonable initial expectations is not bashed for being a naysayer. (I understand mannmade has earned the respect.) True to my commitment to only comment with fact, another current rate-determining factor is the pre-authorization requirement of most payors. Yes, there are more than enough current insulin patients who qualify, but bringing on new patients will require injection trial first, or providers who are willing to play tough with the payors. As Afrezza proves to be a better first-line and the pharmacoencomics are clear, the pre-auth requirements will evaporate, and the tier will be lowered. Hi OD, A few hours you said: Here is my gift to you/others - I am off the board until I have a position and/or I have unassailable facts to share. Fair enough? So did you buy shares and aquired a position or is there some unassailable fact you are sharing and that I can't figure out? Seems your 'promise' didn't last very long? This being said I really don't mind you posting as much as you want (and not keep your 'promise') but I did want to point out something you said just a few hours ago. Kind of follows a pattern though?
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Post by babaoriley on Feb 8, 2015 0:55:06 GMT -5
I believe most investors, although pumped up right now, realize that this will take a few quarters. No one thinks on March 1st they will announce that Danbury cannot keep up with demand. I don't personally believe pre-authorizations are going to be an issue- 2 years from now no one will even connect the two. I'm not convinced it's that much of a major issue now. Not an unreasonable point of view, and many are inclined to agree, although I believe it will all happen a bit faster. However, your scenario is exactly why I implore option buyers to at least consider Jan 2017 as opposed to Jan 2016.
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Post by od on Feb 8, 2015 1:18:16 GMT -5
So nice that someone with reasonable initial expectations is not bashed for being a naysayer. (I understand mannmade has earned the respect.) True to my commitment to only comment with fact, another current rate-determining factor is the pre-authorization requirement of most payors. Yes, there are more than enough current insulin patients who qualify, but bringing on new patients will require injection trial first, or providers who are willing to play tough with the payors. As Afrezza proves to be a better first-line and the pharmacoencomics are clear, the pre-auth requirements will evaporate, and the tier will be lowered. Hi OD, A few hours you said: Here is my gift to you/others - I am off the board until I have a position and/or I have unassailable facts to share. Fair enough? So did you buy shares and aquired a position or is there some unassailable fact you are sharing and that I can't figure out? Seems your 'promise' didn't last very long? This being said I really don't mind you posting as much as you want (and not keep your 'promise') but I did want to point out something you said just a few hours ago. Kind of follows a pattern though? Good evening jpg - Please reread the post - "True to my commitment to only comment with fact"...yes, it is a fact that most payors currently require pre-authorization. I do not give gifts and ask for them back. (And had I used the word promise, which I did not, I do not break promises.)
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Post by jpg on Feb 8, 2015 1:39:47 GMT -5
Hi OD, A few hours you said: Here is my gift to you/others - I am off the board until I have a position and/or I have unassailable facts to share. Fair enough? So did you buy shares and aquired a position or is there some unassailable fact you are sharing and that I can't figure out? Seems your 'promise' didn't last very long? This being said I really don't mind you posting as much as you want (and not keep your 'promise') but I did want to point out something you said just a few hours ago. Kind of follows a pattern though? Good evening jpg - Please reread the post - "True to my commitment to only comment with fact"...yes, it is a fact that most payors currently require pre-authorization. I do not give gifts and ask for them back. (And had I used the word promise, which I did not, I do not break promises.) Hi OD, Sorry my bad. I just figured that you would regroup and come up with more 'unassailable facts' then a generic statement which would apply to basically almost every new drug launch before posting something hoping it will stick. What you are saying is that every new drug (including Afrezza) has some entry barriers to climb over. Yeah.. Again unless you now officially have shares we just don't have the same meaning for 'unassailable facts" I guess. Are you goimg to buy shares now or are you waiting for an even more major pullback?
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Post by dreamboatcruise on Feb 8, 2015 3:25:34 GMT -5
I believe most investors, although pumped up right now, realize that this will take a few quarters. No one thinks on March 1st they will announce that Danbury cannot keep up with demand. I don't personally believe pre-authorizations are going to be an issue- 2 years from now no one will even connect the two. I'm not convinced it's that much of a major issue now. Not an unreasonable point of view, and many are inclined to agree, although I believe it will all happen a bit faster. However, your scenario is exactly why I implore option buyers to at least consider Jan 2017 as opposed to Jan 2016. But the March 2015 OTM calls seem so cheap in comparison. It's almost like a lottery ticket... how could you not spend a dollar to win $100M? [caveat: don't take investing or gambling advice from a lizard]
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Post by liane on Feb 8, 2015 5:50:15 GMT -5
gomnkd, We've long had links to your excellent blog (even if BD doesn't remember them). Here's one I posted; if you do a search on this board for "afresa.blogspot" you will come up with most of the other links. mnkd.proboards.com/post/2065/thread
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Post by Deleted on Feb 8, 2015 7:23:03 GMT -5
Hi OD, A few hours you said: Here is my gift to you/others - I am off the board until I have a position and/or I have unassailable facts to share. Fair enough? So did you buy shares and aquired a position or is there some unassailable fact you are sharing and that I can't figure out? Seems your 'promise' didn't last very long? This being said I really don't mind you posting as much as you want (and not keep your 'promise') but I did want to point out something you said just a few hours ago. Kind of follows a pattern though? Good evening jpg - Please reread the post - "True to my commitment to only comment with fact"...yes, it is a fact that most payors currently require pre-authorization. I do not give gifts and ask for them back. (And had I used the word promise, which I did not, I do not break promises.) Please provide a link that suggests that "most payors require pre-authorization"? Because imo, that's not fact, that's conjecture. As a simple comparison, using the MMIT addon, I see that in my area four major providers are tier 3 with no preauthorizarion.
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Post by mnholdem on Feb 8, 2015 10:28:52 GMT -5
Not an unreasonable point of view, and many are inclined to agree, although I believe it will all happen a bit faster. However, your scenario is exactly why I implore option buyers to at least consider Jan 2017 as opposed to Jan 2016. But the March 2015 OTM calls seem so cheap in comparison. It's almost like a lottery ticket... how could you not spend a dollar to win $100M? [caveat: don't take investing or gambling advice from a lizard] I agree, which is why I picked up 100 contracts for the MAR 20 2015 7.00 C a few weeks ago. I think Baba's also right about the 2017's compared to the 2016's and I'll be starting to accumulate some Jan 2017 before long. But for now there is some low-hanging fruit that needs to be picked.
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Post by od on Feb 8, 2015 11:07:24 GMT -5
Good evening jpg - Please reread the post - "True to my commitment to only comment with fact"...yes, it is a fact that most payors currently require pre-authorization. I do not give gifts and ask for them back. (And had I used the word promise, which I did not, I do not break promises.) Hi OD, Sorry my bad. I just figured that you would regroup and come up with more 'unassailable facts' then a generic statement which would apply to basically almost every new drug launch before posting something hoping it will stick. What you are saying is that every new drug (including Afrezza) has some entry barriers to climb over. Yeah.. Again unless you now officially have shares we just don't have the same meaning for 'unassailable facts" I guess. Are you goimg to buy shares now or are you waiting for an even more major pullback? Good Sunday jpg - My bad for using 'unassailable'; apologies. Agreed, every new compound has hurdles, higher still for new therapeutic modalities. Are my 'measure twice, cut once' comments more generic than that of many others who are long for the long haul. Not quite sure why owning any equity has bearing on a fact being a fact, or not. If Mrs od being a shareholder, qualifies under my 'gift to you' commitment, then I will probably qualify after first NRx results - we've all been around long enough to know that there will be an overreaction, either way. If it creates a better buying opportunity, good for us, if we have to pay up, in the long run we will still enjoy the fruits.
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Post by od on Feb 8, 2015 11:25:28 GMT -5
Good evening jpg - Please reread the post - "True to my commitment to only comment with fact"...yes, it is a fact that most payors currently require pre-authorization. I do not give gifts and ask for them back. (And had I used the word promise, which I did not, I do not break promises.) Please provide a link that suggests that "most payors require pre-authorization"? Because imo, that's not fact, that's conjecture. As a simple comparison, using the MMIT addon, I see that in my area four major providers are tier 3 with no preauthorizarion. Morning fugacity - Perhaps somewhere between 'fact' and 'logical conjecture'; my payor and PBM research, which could be flawed, indicates most big players require prior authorization and/or step therapy (no prior auth at Tricare, GREAT). I do not believe tier placement is a barrier. I continue to believe that there is an embedded base of qualified patients to make 2015 a very good year.
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Post by mannmade on Feb 8, 2015 11:35:58 GMT -5
mannmade... I agree that Novolog isn't apples to apples, but I think you might be underestimating the effect of ease of prescribing Afrezza for primary care physicians and the pent up demand from patients overdue for prandial. You may be right, but I would really like to see the numbers regardless. If the numbers look less than great as you suggest, I'd sooner know it upfront rather than wait for a FUD hit piece pointing it out. dbc, think I missed your post from earlier so apologies for the late reply... I hope I am wrong and am not looking to be right on this... And I have always maintained that although I think initial NRx will be lower than I might like that the positive % QxQ growth (which I do expect) will help fuel a steady increase in the pps for the first full 12 months of sales. The irony to me is that I think if Afrezza were an injectable therapy then we would get much greater and faster adoption, after all the PK profile is a huge advance. I think because it is a new first in class therapy and the inhalation aspect is so new that there will likely be lingering doubts for many whether it is because of lung function decrease, cancer or other concerns. I personally would not hesitate to use it from what I know, if I were in need of an insulin therapy. However, with all due respect to many potential patients at this point I may know more about Afrezza, (not more about diabetes and certainly I know nothing about living with it) then they currently know as I have been following diligently for almost 7 years. However I believe many will catch up and catch on as time goes on and the community conversation evolves. In the meantime I would go after the 20 to 35 yr olds who are also the early adopters in tech. They will likely have less fear of a new first in class drug and seek the improved lifestyle as theirs is most likely to be a lifestyle from which the benefits of no needles and excess carb eating etc... would benefit the most...imho. And btw, the numbers Savzak posted from YMB/kevinmik earlier today if accurate seem to bode well for Afrezza when you also consider the great word of mouth that is starting to take shape. Afrezzauser has been truly unbelievable for what he has done for Afrezza so far (Sanofi should put a Statue of him outside their HQ if Afrezza takes off ) But I am very heartened to see Peekabull and Brian 12376 (?) join him online and hope to see others so he does not get over exposed and hence devalue his message.
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Post by ezrasfund on Feb 8, 2015 12:08:57 GMT -5
The issue of pulmonary delivery just points out the state of ignorance about how our bodies work. We will probably not see these misconceptions dispelled in our lifetime, but they are misconceptions nonetheless. So the skeptics will continue to worry about the dangers of inhaling, but not the dangers of ingesting or injecting.
When you inject something, even subcutaneously, you are introducing that substance into a part of the body that is sterile, and into tissue that under normal conditions does not encounter any foreign substances that are not manufactured or at least filtered by the body.
By contrast your lungs are designed to encounter the whole outside world. They are teeming with bacteria. Google lung microbiome. They encounter all the dust and pollen and every other particle and gas in the air. Everything you have smelled has been in your lungs. When someone slurps on a very hot pumpkin spice coffee you can be sure that a trace of cinnamon (or whatever else they put in there) has made it deep into the lungs.
Sure there are things that are bad to inhale, and injest and inject. But there is no reason to think that inhaling insulin is inherently worse than injecting. Why are people not developing cancerous lesions around their injection sites? Yes, smoking tobacco causes cancer, but so does chewing tobacco. Has anyone tried injecting?
Let's just say that even in this golden age of science there is still enough misunderstanding to go around.
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Post by savzak on Feb 8, 2015 12:26:20 GMT -5
Ezra, terrific post. In all my years in MNKD I had never considered that perspective.
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Post by 4allthemarbles on Feb 8, 2015 14:05:31 GMT -5
What an excellent perspective. Thank you Ezra.
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