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Post by mindovermatter on Jan 3, 2016 14:34:53 GMT -5
This is an interesting thread, and I thank Mnkdnewb for reminding us of cfield's excellent post earlier this year. I liked it then and I like it now, and nothing really has changed except an overdue change in leadership at MNKD after a less than inspiring offering on the TASE that did little other than feed the narrative that MNKD is desperate. This well intentioned but poorly timed faux pas by Mr. Edstrom fostered more confidence by the dark side and encouraged them to double down on their FUD, which seems to have been successful in getting many more weak hands to fold. Like others on this board, my wife and I saw "The Big Short" last night. It should be required for everyone who cares about the future of the nation. Anyone who views this true account of how Wall Street raped the country in 2008 without concluding that the market is still broken and badly needs reform might benefit from a soulful reflection on the true meanings of humanity, integrity and greed. The movie made it clear that what is happening with MNKD and other vulnerable stocks is entirely understandable in a market that learned no lessons in 2008 other than that being manipulative, arrogant and greedy can reap large rewards without penalty. The only satisfying part of the movie was seeing that those who predicted the crash and shorted the derivatives actually had some moral misgivings about profiting at the expense of average, hardworking people who lost their homes, jobs, savings and health because the church of greed was (and remains) the largest religious denomination in America. What we see in MNKD and the re-emergence of synthetic CDO's again trading on Wall Street is that the market remains so broken it no longer reflects reality. This partially explains why MNKD is trading at its current level. I applaud other longs who have done their due diligence and have stayed the course during these very dark times. Scion Investments, a company that did its due diligence and persisted despite weak-handed investors, massive ridicule, and efforts by Wall Street to hide the truth, ended up 489% after the crash. I remain convinced that long investors will also find ourselves with returns considerably better than what is reflected in today's share price. Good luck to you and sincere New Year's wishes for health, happiness, peace and justice. Chris C Don't forget Wall St had a very willing accomplice that set up the rules and regulation to allow it to do what it did. I'll let you guess who that entity was.
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Post by peppy on Jan 3, 2016 14:57:05 GMT -5
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Post by suebeeee1 on Jan 3, 2016 16:03:07 GMT -5
I don't know if it has been deadly or brilliant. I'll wait my decision until I hear more...that is IF I ever hear more!
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Post by EveningOfTheDay on Jan 3, 2016 22:25:08 GMT -5
Hard to tell from where I stand on whether Sanofi's strategy was or will be any good. All I can say is that both Mannkind and Sanofi itself wet rather wrong in terms of expectations. That is not a comforting thing when it is obvious they had years and years to think through some of the issues they are now facing. The one thing out of their control was the label and perhaps that is enough of a factor to skew everything else, but if that is the case the plan should include, before anything else, trials, gathering of data and anything and everything to get a change in label as quickly as possible. Perhaps that is what Sanofi is attempting to do, and perhaps they are trying to do this in the cheapest possible way for sound reasons, but I think the jury is still out on their performance as commercial partners. For the time being I remain unimpressed.
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Post by lakers on Jan 3, 2016 23:37:02 GMT -5
Hard to tell from where I stand on whether Sanofi's strategy was or will be any good. All I can say is that both Mannkind and Sanofi itself wet rather wrong in terms of expectations. That is not a comforting thing when it is obvious they had years and years to think through some of the issues they are now facing. The one thing out of their control was the label and perhaps that is enough of a factor to skew everything else, but if that is the case the plan should include, before anything else, trials, gathering of data and anything and everything to get a change in label as quickly as possible. Perhaps that is what Sanofi is attempting to do, and perhaps they are trying to do this in the cheapest possible way for sound reasons, but I think the jury is still out on their performance as commercial partners. For the time being I remain unimpressed. IMHO, Sanofi underestimated what it took to place Afrezza on Tier 2. BP's exclusive deal w/ CVS caught them off guard. Others PBM would not cover Afrezza as Tier 2 at premium price w/o a vastly more superior label. Sanofi should have initiated the superiority and post marketing trials in late 2014. They burnt a lot of time. Had they done that, Afrezza would have had a good chance to get Tier 2 on some PBMs in 2016. They will likely start 6-mo superiority trial 1Q16 and EMA, ME MAA in parallel. It's better late than never. DeSisto will need to articulate the business model going forward at the 1/13/16 JPM Conf.
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Post by sweedee79 on Jan 4, 2016 0:36:14 GMT -5
There is a lot of merit to the strategy of a controlled launch. To me it's difficult to rectify how controlled when the former CEO stated Afrezza sales were "certainly" disappointing. It was also stated it was understood why, but in typical fashion nothing was said as to whether that would be or was being addressed. I'm sure it is being addressed and there is coincidental evidence, but it would be helpful to hear directly from the horse's mouth. I'm not soft bashing, I just can't get the concept of a controlled strategy and this statement to correlate, and would appreciate having it explained. First SNY has launched many drugs so I believe they have good sense and knowledge when it comes to doing this. The launch of each drug is very different and you have to understand your market ... Do a google search on launching a new drug and you will see that it is complex and a well planned approach is necessary .. one of the important things to be able to do is differentiate your drug from others in the market ..
social.eyeforpharma.com/uncategorised/seven-worst-mistakes-pharma-launch-and-secrets-avoid-them
Right now we have some issues... one being the label .. It is hard to differentiate Afrezza from other insulin when the label and also the FDA doesn't allow for this. We know what Afrezza is.. problem is the medical community does not.. nor does the label support this... Afrezza represents a change in the standard of care...
The current standard of care in treating PWD is to give them the smallest amount of injectable meal time insulin possible... they do this to avoid hypo and also weight gain and other problems that arise with injectable insulin .. such as further insulin resistance. Also, an A1C of 7 is acceptable even when we know damage still happens at this A1C level.. According to the current standard of care the risk of trying to get a lower and/or normal A1C isn't worth it because of the risk and serious dangers of hypo... so PWD have been forced to accept a less than perfect situation but the only one that has been available to them until now ..
Afrezza offers something very different... the ability to prescribe higher doses of insulin with a much lower risk of hypo.... no weight gain .. and consequently a lower and possibly normal A1C .. it is a change in the standard of care... However, until we can SAY this.. and get docs to know and trust this, we have a problem differentiating Afrezza ..
This is why we cannot simply chase patients to the docs with a huge DTC campaign at this time .. the docs are slow to change for one .. You cant prescribe Afrezza the very same way as injectable and get optimal and differentiated results unless you understand Afrezza ... It would be a set up for failure...
Sorry I'm not really good with words.. But this has been my experience with Afrezza while trying to help my dad get on the drug successfully ... the docs had him on a dose that was not high enough .. were trying to prescribe it the same way as injectable(per the instruction sheet) ..ITS NOT THE SAME... LOL.. nothing I said would change their minds.. and we had problems with insurance .the spiro was NOT a problem... My dad has discontinued use until Afrezza is more established .. This is what happens when the market isn't ready for the drug .. SNY's job is to prepare the market and get label changes or somehow legally bypass them so that we can have a successful launch ..
Many investors seem to think that all you have to do is advertise and put the product out there with very little preparation, then things will take care of themselves... It doesn't work that way and especially with a drug that has label constraints as to what we can claim to the market, and also represents a complete change in the way docs have thought about and treated diabetes and also prescribed insulin in the recent past ...
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Post by mnkdnut on Jan 4, 2016 3:39:18 GMT -5
A good superiority study is so central to every aspect of marketing Afrezza. Without it, payers and prescribers can easily look at it as added cost and unknown long-term lung health risk for patient convenience and non-inferior efficacy. That's a very tough sell in today's cost sensitive environment. We should naturally be concerned and impatient that there has been no announcement of the start of such a foundational study yet. Feels negligent. However, it would be a bigger mistake if Sanofi jumped in too soon, without understanding the critical nuances of dosing and timing, and just repeated non-inferior results. The San Diego meeting was the first hint that SNY intends to really understand what makes Afrezza works so well before creating the protocol for a superiority study. I just hope it's worth the painful wait!
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Post by sweedee79 on Jan 4, 2016 3:41:59 GMT -5
I want to add that I have no idea why Hakan said the sales were "certainly disappointing".... that comment concerned me as well ... but it could be part of the reason why our former CEO is no longer in that position ... it was an irresponsible statement on his part imo .. How could they expect great sales with such a soft launch, label constraints etc etc etc... ?
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Post by sportsrancho on Jan 4, 2016 5:55:43 GMT -5
I want to add that I have no idea why Hakan said the sales were "certainly disappointing".... that comment concerned me as well ... but it could be part of the reason why our former CEO is no longer in that position ... it was an irresponsible statement on his part imo .. How could they expect great sales with such a soft launch, label constraints etc etc etc... ? That's been the question in my mind also. If the slow launch was planned why the disappointment? The answer is in Lakers post above. IMO. Love your posts, they have helped a lot and been a real eye opener!
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Post by bretzyboy on Jan 4, 2016 6:12:24 GMT -5
sweedee79; Thanks for the excellent response. I can't get the like button to cooperate.
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Post by peppy on Jan 4, 2016 6:19:00 GMT -5
There is a lot of merit to the strategy of a controlled launch. To me it's difficult to rectify how controlled when the former CEO stated Afrezza sales were "certainly" disappointing. It was also stated it was understood why, but in typical fashion nothing was said as to whether that would be or was being addressed. I'm sure it is being addressed and there is coincidental evidence, but it would be helpful to hear directly from the horse's mouth. I'm not soft bashing, I just can't get the concept of a controlled strategy and this statement to correlate, and would appreciate having it explained. First SNY has launched many drugs so I believe they have good sense and knowledge when it comes to doing this. The launch of each drug is very different and you have to understand your market ... Do a google search on launching a new drug and you will see that it is complex and a well planned approach is necessary .. one of the important things to be able to do is differentiate your drug from others in the market ..
social.eyeforpharma.com/uncategorised/seven-worst-mistakes-pharma-launch-and-secrets-avoid-them
Right now we have some issues... one being the label .. It is hard to differentiate Afrezza from other insulin when the label and also the FDA doesn't allow for this. We know what Afrezza is.. problem is the medical community does not.. nor does the label support this... Afrezza represents a change in the standard of care...
The current standard of care in treating PWD is to give them the smallest amount of injectable meal time insulin possible... they do this to avoid hypo and also weight gain and other problems that arise with injectable insulin .. such as further insulin resistance. Also, an A1C of 7 is acceptable even when we know damage still happens at this A1C level.. According to the current standard of care the risk of trying to get a lower and/or normal A1C isn't worth it because of the risk and serious dangers of hypo... so PWD have been forced to accept a less than perfect situation but the only one that has been available to them until now ..
Afrezza offers something very different... the ability to prescribe higher doses of insulin with a much lower risk of hypo.... no weight gain .. and consequently a lower and possibly normal A1C .. it is a change in the standard of care... However, until we can SAY this.. and get docs to know and trust this, we have a problem differentiating Afrezza ..
This is why we cannot simply chase patients to the docs with a huge DTC campaign at this time .. the docs are slow to change for one .. You cant prescribe Afrezza the very same way as injectable and get optimal and differentiated results unless you understand Afrezza ... It would be a set up for failure...
Sorry I'm not really good with words.. But this has been my experience with Afrezza while trying to help my dad get on the drug successfully ... the docs had him on a dose that was not high enough .. were trying to prescribe it the same way as injectable(per the instruction sheet) ..ITS NOT THE SAME... LOL.. nothing I said would change their minds.. and we had problems with insurance .the spiro was NOT a problem... My dad has discontinued use until Afrezza is more established .. This is what happens when the market isn't ready for the drug .. SNY's job is to prepare the market and get label changes or somehow legally bypass them so that we can have a successful launch ..
Many investors seem to think that all you have to do is advertise and put the product out there with very little preparation, then things will take care of themselves... It doesn't work that way and especially with a drug that has label constraints as to what we can claim to the market, and also represents a complete change in the way docs have thought about and treated diabetes and also prescribed insulin in the recent past ...
Quote: The current standard of care in treating PWD is to give them the smallest amount of injectable meal time insulin possible... they do this to avoid hypo and also weight gain and other problems that arise with injectable insulin .. such as further insulin resistance Afrezza offers something very different... the ability to prescribe higher doses of insulin with a much lower risk of hypo.... no weight gain .. and consequently a lower and possibly normal A1C .. it is a change in the standard of care... You cant prescribe Afrezza the very same way as injectable and get optimal and differentiated results unless you understand Afrezza ... the docs had him on a dose that was not high enough .. were trying to prescribe it the same way as injectable(per the instruction sheet)
Reply; technosphere insulin works so differently to lower blood glucose, the physicians do not understand it. I took Matt to explain it to me. And stevil. screencast.com/t/ZaphFSR2qYT5
When I look at the insulin first phase response and second phase information, I wonder if the clamp study could help prove this. I do not know enough. What is required to prove.
The clamp study has been completed, www.clinicaltrials.gov/ct2/show/results/NCT02470637
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