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Post by peppy on Mar 7, 2017 12:13:56 GMT -5
quote from above: And the FDA takes 10 months to review a label change request. Where would the price be right now if that label change were already approved? What would the strategy be then? Rhetorical questions.
Reply: This label change IS going to take that long. Ultra rapid insulin category does NOT exist. The FDA needs to make a new insulin category? as well as change the Label?
Be still my heart.
Sanofi DID the Clamp studies. The only study Sanofi followed through on.
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Post by kbrion77 on Mar 7, 2017 12:36:39 GMT -5
The deal with Sanofi was done by Al in good faith that the marketing will be done correctly. If the old CEO stayed on it would be a different story now. And the valuation would have been 925M for 65% with no effort on MNKD part to market so they could focus on the pipeline. IMO it was a decent deal for MNKD because Al wanted to bring it to global market ASAP and Sanofi looked the part. The mistake was not to raise insurance capital at that time or in 2015. Afrezza still commands the same valuation and more based on the label changes coming up. MNKD is not giving it away because it knows the value. I firmly believe that they are talking to companies that can help bring it to global markets by next year, if not sooner. That is what I believe Afrezza needs now - script volume at lower margins. The fact that they are filing in other regions says that they changed their strategy (to first make it a success in US market). There is still a big disconnect between IP and how that IP has been marketed to date. You can value Afrezza in any which way you want all that matters is what a company is willing to pay for it. I have the most beautiful house in the worst neighborhood how come I can't get what I think the house is worth? It is becoming clearer and clearer that Matt and Co. are putting all their eggs in one basket and will take the rest of the ship down with it if it fails.
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Post by peppy on Mar 7, 2017 12:43:07 GMT -5
The deal with Sanofi was done by Al in good faith that the marketing will be done correctly. If the old CEO stayed on it would be a different story now. And the valuation would have been 925M for 65% with no effort on MNKD part to market so they could focus on the pipeline. IMO it was a decent deal for MNKD because Al wanted to bring it to global market ASAP and Sanofi looked the part. The mistake was not to raise insurance capital at that time or in 2015. Afrezza still commands the same valuation and more based on the label changes coming up. MNKD is not giving it away because it knows the value. I firmly believe that they are talking to companies that can help bring it to global markets by next year, if not sooner. That is what I believe Afrezza needs now - script volume at lower margins. The fact that they are filing in other regions says that they changed their strategy (to first make it a success in US market). There is still a big disconnect between IP and how that IP has been marketed to date. You can value Afrezza in any which way you want all that matters is what a company is willing to pay for it. I have the most beautiful house in the worst neighborhood how come I can't get what I think the house is worth? It is becoming clearer and clearer that Matt and Co. are putting all their eggs in one basket and will take the rest of the ship down with it if it fails. We seem to be in a bad neighborhood, full of thugs. Thugs that are supplying bad, poorly working therapeutic drugs and stopping other therapeutic drugs from coming in to the neighborhood. The thugs telling us to be thankful we have the poorly working potentially deadly drugs we have. Is that the definition of a crime circuit?
The Federal Class Action lawsuit against Sanofi, Novo Nordisk and Eli Lilly was filed on 1/30/2017 on charges of colluding in insulin price fixing, among other things. The web of corruption that runs among these three companies is an intricate one.
Insulin is a crime circuit? Oh.
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Post by dreamboatcruise on Mar 7, 2017 13:01:28 GMT -5
quote from above: And the FDA takes 10 months to review a label change request. Where would the price be right now if that label change were already approved? What would the strategy be then? Rhetorical questions.
Reply: This label change IS going to take that long. Ultra rapid insulin category does NOT exist. The FDA needs to make a new insulin category? as well as change the Label?
Be still my heart.
Sanofi DID the Clamp studies. The only study Sanofi followed through on.
I think hard to predict impact of label change, even presuming that we know that calling it "ultra rapid" is what is intended. I don't think that would be a guarantee that doctors would view it differently or that payer coverage would be better. Both doctors and those making decisions about coverage could see the clamp data and know what it means even without a new adjective. Some patients may realize the benefits that could be had with a faster insulin, but many may not. Running an ad that says "ultra rapid" still isn't the same as connecting it to something that the patients know they have a problem with... A1c, hypos, etc. Will be interesting to see what changes we get and when.
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Post by peppy on Mar 7, 2017 13:05:59 GMT -5
quote from above: And the FDA takes 10 months to review a label change request. Where would the price be right now if that label change were already approved? What would the strategy be then? Rhetorical questions.
Reply: This label change IS going to take that long. Ultra rapid insulin category does NOT exist. The FDA needs to make a new insulin category? as well as change the Label?
Be still my heart.
Sanofi DID the Clamp studies. The only study Sanofi followed through on.
I think hard to predict impact of label change, even presuming that we know that calling it "ultra rapid" is what is intended. I don't think that would be a guarantee that doctors would view it differently or that payer coverage would be better. Both doctors and those making decisions about coverage could see the clamp data and know what it means even without a new adjective. Some patients may realize the benefits that could be had with a faster insulin, but many may not. Running an ad that says "ultra rapid" still isn't the same as connecting it to something that the patients know they have a problem with... A1c, hypos, etc. Will be interesting to see what changes we get and when. I am sure the pushers will keep their stance. Who are the pushers? Suppliers and pushers... interesting point of view. Additionally, publicly educated pushers, all with the same brain washing techniques. wow
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Post by buyitonsale on Mar 7, 2017 13:10:20 GMT -5
Location, Location, Location Epi house is being built as we speak. Brand new, modern design and only 1 competing listing that is old and overpriced. Well, keep pursuing your investment thesis. I do.
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Post by careful2invest on Mar 7, 2017 19:01:03 GMT -5
Running an ad that says "ultra rapid" still isn't the same as connecting it to something that the patients know they have a problem with... A1c, hypos, etc.
"Running an ad..."?? Running an ad period, could do some really amazing things...Like actually sell your product! Or at minimum, get people talking about AFREZZA! Realizing that AFREZZA really does exist and actually works! That alone would be a refreshing concept for MNKD to finally adopt! As for MNKD's MO... It just does not make sense!
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Post by rickf on Mar 7, 2017 19:25:13 GMT -5
At this point --- even IF the FDA got pissed off it just might shine a light on the product and get "free" press that would get noticed! I agree with folks here that are EXTREMELY worried that it will not be here unless they do something --- ANYTHING!! So what if the FDA get pissed! Soon if they do nothing they will not have to worry about ANY FDA issues!! It is WAY too late to put on a lifejacket when the boat is sitting at the bottom of the lake!! So --- I say -- let er rip! ULTRA FAST ACTING and advertise the crap out of those words!
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Post by sayhey24 on Mar 7, 2017 20:35:23 GMT -5
You can value Afrezza in any which way you want all that matters is what a company is willing to pay for it. I have the most beautiful house in the worst neighborhood how come I can't get what I think the house is worth? It is becoming clearer and clearer that Matt and Co. are putting all their eggs in one basket and will take the rest of the ship down with it if it fails. We seem to be in a bad neighborhood, full of thugs. Thugs that are supplying bad, poorly working therapeutic drugs and stopping other therapeutic drugs from coming in to the neighborhood. The thugs telling us to be thankful we have the poorly working potentially deadly drugs we have. Is that the definition of a crime circuit?
The Federal Class Action lawsuit against Sanofi, Novo Nordisk and Eli Lilly was filed on 1/30/2017 on charges of colluding in insulin price fixing, among other things. The web of corruption that runs among these three companies is an intricate one.
Insulin is a crime circuit? Oh.
Just to keep things straight on the insulin price fixing. Two things are going on; the federal action lawsuit filed by Steve Berman, a lawyer whose firm filed the suit on behalf of patients; and a criminal investigation request by Bernie Sanders. www.sanders.senate.gov/newsroom/press-releases/sanders-cummings-request-doj-and-ftc-investigate-cost-of-diabetes-products Whether the criminal investigation is ongoing would be a secret but I have not seen anything to say the DOJ is not doing it. Now, I am at a loss when it comes to what MNKD is doing. It still does not make sense why MNKD was so happy during 2015 when Sanofi; sold no product; did no advertising; did not submit for EU approval; did not put the Juvenal study together; did not put the lung study together; and a few more things. At the same time the guy in charge of doing all this and did nothing; put a plan together; sold Sanofi on it and got $250M; sold Google/Verily on it and got a partnership; sold Dexcom on it; got a promotion and is now heading up the Alliance; and is still targeting that same PCP T2 market that he said was the sweet spot and should be using insulin. That must be some plan. If I was Matt, I would have asked to see it. Currently MNKD tells us they are targeting the Endo market. This is the market Sanofi with Ondou is not interested in. Yet, Onduo must have a heck of a plan and both Google and Sanofi think the PCPs are the sweet spot for insulin use. I find it odd MNKD has no interest in it especially if the Endos have little interest in using a simpler, no carb counting, less risky, better performing solution. On top of that Sanofi and MNKD agree to a settlement which has the value of a few months to get Mannkind closer to the end of 2017. Is MNKD really moving forward or are they in the four corner delay? I just do not see the urgency. We get a head fake on a contract sales force that sold nothing. Now we get another restart with another sales force. On week 3 on the street we get no sales. We get no advertising when I could pick up the phone and get some national radio commercials on the air next week which might have a few people asking their doctor about afrezza. No international movement. No lung function study. No EU application. Man, I think I heard this song before. Houston, do we have a problem or is there a plan? Nobody can be this inept and I just don't think the foundation nor estate have any interest in selling. To me it looks like Matt was put in place as the CEO to run out the clock. Otherwise they would have brought in an M&A guy to do a deal. No one lets a 17 year, $2.5B investment die on the vine without a fight. I don't think the foundation people are crazy. I bet that guy representing "G"hina still wants to do a deal and I believe I remember Matt saying that he was one of many who wanted to do deals. Amphastar was rumored to wanting to do a deal and all they got was an option and it looked like they had leverage.
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Post by kbrion77 on Mar 7, 2017 21:01:55 GMT -5
We seem to be in a bad neighborhood, full of thugs. Thugs that are supplying bad, poorly working therapeutic drugs and stopping other therapeutic drugs from coming in to the neighborhood. The thugs telling us to be thankful we have the poorly working potentially deadly drugs we have. Is that the definition of a crime circuit?
The Federal Class Action lawsuit against Sanofi, Novo Nordisk and Eli Lilly was filed on 1/30/2017 on charges of colluding in insulin price fixing, among other things. The web of corruption that runs among these three companies is an intricate one.
Insulin is a crime circuit? Oh.
Just to keep things straight on the insulin price fixing. Two things are going on; the federal action lawsuit filed by Steve Berman, a lawyer whose firm filed the suit on behalf of patients; and a criminal investigation request by Bernie Sanders. www.sanders.senate.gov/newsroom/press-releases/sanders-cummings-request-doj-and-ftc-investigate-cost-of-diabetes-products Whether the criminal investigation is ongoing would be a secret but I have not seen anything to say the DOJ is not doing it. Now, I am at a loss when it comes to what MNKD is doing. It still does not make sense why MNKD was so happy during 2015 when Sanofi; sold no product; did no advertising; did not submit for EU approval; did not put the Juvenal study together; did not put the lung study together; and a few more things. At the same time the guy in charge of doing all this and did nothing; put a plan together; sold Sanofi on it and got $250M; sold Google/Verily on it and got a partnership; sold Dexcom on it; got a promotion and is now heading up the Alliance; and is still targeting that same PCP T2 market that he said was the sweet spot and should be using insulin. That must be some plan. If I was Matt, I would have asked to see it. Currently MNKD tells us they are targeting the Endo market. This is the market Sanofi with Ondou is not interested in. Yet, Onduo must have a heck of a plan and both Google and Sanofi think the PCPs are the sweet spot for insulin use. I find it odd MNKD has no interest in it especially if the Endos have little interest in using a simpler, no carb counting, less risky, better performing solution. On top of that Sanofi and MNKD agree to a settlement which has the value of a few months to get Mannkind closer to the end of 2017. Is MNKD really moving forward or are they in the four corner delay? I just do not see the urgency. We get a head fake on a contract sales force that sold nothing. Now we get another restart with another sales force. On week 3 on the street we get no sales. We get no advertising when I could pick up the phone and get some national radio commercials on the air next week which might have a few people asking their doctor about afrezza. No international movement. No lung function study. No EU application. Man, I think I heard this song before. Houston, do we have a problem or is there a plan? Nobody can be this inept and I just don't think the foundation nor estate have any interest in selling. To me it looks like Matt was put in place as the CEO to run out the clock. Otherwise they would have brought in an M&A guy to do a deal. No one lets a 17 year, $2.5B investment die on the vine without a fight. I don't think the foundation people are crazy. I bet that guy representing "G"hina still wants to do a deal and I believe I remember Matt saying that he was one of many who wanted to do deals. Amphastar was rumored to wanting to do a deal and all they got was an option and it looked like they had leverage. Houston we have a problem, stick to that thesis you will sleep better. Nobody knows what to do with this drug I firmly believe it may be ahead of its time.
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Post by sayhey24 on Mar 7, 2017 21:20:40 GMT -5
"Nobody knows what to do with this drug" really, nobody? Wow! Prior to real time sensors I might agree with you but between the Libre and G5, CGMs are getting cost effective and common place. There are a bunch of smart guys out there and Nobody can figure out what to do with the only treatment which works just like a healthy pancreas. Yet there are a bunch of people on this board that understand the impact afrezza could have on peoples lives and we have afrezza users who tell us it is "life changing". To quote Kevin Sayers when asked about the social media reports he said "I have never seen anything like it". Now, Kevin seems like a smart guy. He even has a deal going with the same folks as our ex-Sanofi afrezza manager. It seems odd a smart guy like Kevin who has been in the diabetes market for a while can't figure something out. Just saying, something seems odd.
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Post by goyocafe on Mar 7, 2017 21:28:57 GMT -5
You left out pediatric trials seem to have taken a back seat to the back seat. Never ceases to amaze me, too.
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Post by nadathing on Mar 7, 2017 21:42:33 GMT -5
Location, Location, Location Epi house is being built as we speak. Brand new, modern design and only 1 competing listing that is old and overpriced. Well, keep pursuing your investment thesis. I do. They announced the Epi application over a year. Were they looking for a partner? If so, it appears there is no interest. Or, maybe they can finance trials on their own. I don't know.
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Post by Deleted on Mar 7, 2017 21:46:38 GMT -5
Location, Location, Location Epi house is being built as we speak. Brand new, modern design and only 1 competing listing that is old and overpriced. Well, keep pursuing your investment thesis. I do. is the house all done and listed? or at least framed , so prospective buyers can choose the finishing? or there is just vacant land and you building the house in your dreams? In the former, it would be nice. In the later, its as if nothing existed.
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Post by mnkdfann on Mar 7, 2017 21:54:44 GMT -5
I think that a criminal investigation into insulin pricing etc. would not have to be kept secret. The Justice Department has announced the start of criminal investigations before. Lots of examples, just google the topic. I rather imagine this example is just the type that Justice WOULD announce.
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