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Post by Deleted on Apr 17, 2016 9:51:27 GMT -5
With out knowing the reason why , that statement is a moot point . Maybe it was a bit cryptic If you type Sanofi Afrezza two-thirds into Google which is all I did it is the first hit. It would have been quicker for them to google it than to ask. I posted that for the statement 2/3of the people dropped . Yes they dropped but Sanofi should have stated why they dropped which would make the picture complete . I had no questions on the article and where to find that
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Post by buyitonsale on Apr 17, 2016 15:45:09 GMT -5
I have to say I agree with parts of what both of you are saying. But wasn't it just a few days ago that matt was telling us to do a straddle? I think we're getting out matts mixed up. The matt that deserves some slack is the one at MNKD. The straddle matt is the one on this board. Do I have that right, or am I the one all mixed up??? Anyway, to buyitonsale..... don't you think every mnkd shareholder has had BK in the back of their minds for months??? what do you think a stock price that's just slightly north of a buck reflects, peaches and cream and all things hunky dory??? if you think matt is playing us for fools and you're worried about BK, you really should sell. And in response to someone else on this or some other thread, in terms of extending the cash runway, I, for one, would be perfectly okay with MNKD selling a 100 million shares if that could bring in around $150 million. User names on this board do not have capital letters. Real names do. That helps avoiding confusion, at least for most here. The topic of this thread has to do with the theme of upcoming CC, which seems to be out of sequence to me and obviously will not have any material info regarding the cash situation. The point of this thread, which most are avoiding is the fact that we are in April, cash will only last until July at best and management decides to discuss commercialization strategy in US... Thus inevitably hurting the stock, unless there is a PR on Monday or Tuesday. I will defintely let you know when I sell my shares (I have bought 150K so far since August 2014 and have not sold any yet). Usually urging others to sell implies a) no position, b) short position, c) being bitter from selling at a loss. Such people are also in denial that self preservation is not their #1 instinct. They are not prepared to deal with that aspect and will most likely sell themselves at the first real sign of trouble. I have seen this on this board when TASE dual listing debacle unfolded. I bought more at that time. I also bought at .75 and .65 in January. My last purchase was at .94 right before Al passed away. I am sure that many "investors" on this board sold in January when Sanofi cancelled the agreement. I consider myself a true Mannkind investor and I am calling it as I see it. I am also prepared to face the reality (see the self preservation reference above and remember that MNKD management and BOD are also human just like the rest of us). I have actually emailed Matt (with a capital M) several times and encouraged him after his appointment as CEO and after MNKD 2.0 presentation. But, when I think differently I will speak up as well. There a lot of smart people on this board and I enjoy reading it, but staying on topic seems to be a challenge with smart people. Just an observation...
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Post by jerrys on Apr 17, 2016 16:48:57 GMT -5
Maybe it was a bit cryptic If you type Sanofi Afrezza two-thirds into Google which is all I did it is the first hit. It would have been quicker for them to google it than to ask. I posted that for the statement 2/3of the people dropped . Yes they dropped but Sanofi should have stated why they dropped which would make the picture complete . I had no questions on the article and where to find that In your original post, I believe you said that without knowing why they dropped it, the statement was "moot." I can't quite agree with that. If two thirds did indeed walk away, that is hardly moot. Indeed, it is highly relevant and is something MNKD should have investigated and explained to shareholders. Is MNKD itself even aware of that statement by SNY? Reading through the press releases and conference calls, I often get the impression that there was little if any communication between the two companies. What actually happened at the JAC meetings? Shouldn't there be transcripts of those somewhere?
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Post by slugworth008 on Apr 17, 2016 17:57:18 GMT -5
Yep Patten, the M & M's boys will get the job done this time and Sanofi is going to pay for the launch ( Wall ). Ok, Spiro couldn't resist that line. Believe Spiro here, Sanofi is going to pay for it. Spiro here, Afrezza working just fine controlling my diabetes. Sanofi paying for the launch is the sort of settlement I could believe in. It gives a clean hand off and is not a lot of money. I would like nothing better than to have Sanofi pay for the launch - I could certainly believe in that as well. Fingers are crossed for Tuesday's CC.
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Post by buyitonsale on Apr 18, 2016 0:14:41 GMT -5
Yep Patten, the M & M's boys will get the job done this time and Sanofi is going to pay for the launch ( Wall ). Ok, Spiro couldn't resist that line. Believe Spiro here, Sanofi is going to pay for it. Spiro here, Afrezza working just fine controlling my diabetes. I really, really want to believe Spiro here. That would be great on so many levels and why not! I also think that Spiro could possibly be a spokesperson for Afrezza, he exudes confidence but in a relaxed way. Lights, camera, action... "Spiro here, Afrezza working just fine controlling my diabetes." and, cut ... I like it.
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Post by LosingMyBullishness on Apr 18, 2016 3:56:00 GMT -5
I posted that for the statement 2/3of the people dropped . Yes they dropped but Sanofi should have stated why they dropped which would make the picture complete . I had no questions on the article and where to find that In your original post, I believe you said that without knowing why they dropped it, the statement was "moot." I can't quite agree with that. If two thirds did indeed walk away, that is hardly moot. Indeed, it is highly relevant and is something MNKD should have investigated and explained to shareholders. Is MNKD itself even aware of that statement by SNY? Reading through the press releases and conference calls, I often get the impression that there was little if any communication between the two companies. What actually happened at the JAC meetings? Shouldn't there be transcripts of those somewhere? I agree to Iam2sekc4 comment that this statement was 'moot'. A SNY spokesperson gave this argument when they made their decision public and it was intended as a reason why SNY dropped Afrezza. They did not published before or afterwards any more information on this statistics and they did not provide any background on this statement. Therefore I regarded this statement solely for the purpose to give a good legal statement to analysts. If two thirds did indeed walk away, that is hardly moot. I find your statement 'If two thirds did indeed walk away, that is hardly moot.' surprisingly superficial. There are many reasons why people do not continue with a medication they have been given, especially if this is a new medication that both sales reps, endos and patients know very little about. I also found your argument '..is something MNKD should have investigated and explained to shareholders.Is MNKD itself even aware of that statement by SNY?' again either rather ill-informed, naive or intentionally misleading: You and others here at the board do not know to what depth MNKD or SNY have investigated it. You and others do not know if SNY shared the calculation and their research about this number with MNKD's management who were not involved in sales or marketing. And lastly, as this was a public statement from SNY about a matter of high concern to MNKD it is absurd to question that MNKD has at least read this statement that SNY gave tot the media.' It is a repetitive scheme to blame MNKD for poor sales, poor marketing or the lack of information MNKD published about sales of Afrezza. This is often an argument to attest underperformance of MNKD management. You could blame MNKD management for lack of product, bad product quality, an inferior product, lack of product pipeline etc, but blaming it for poor sales and marketing or poor communication about topics they are not allowed to communicate about is actually 'bashing'.
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Post by sf1981 on Apr 18, 2016 6:35:52 GMT -5
I also found your argument '..is something MNKD should have investigated and explained to shareholders.Is MNKD itself even aware of that statement by SNY?' again either rather ill-informed, naive or intentionally misleading: You and others here at the board do not know to what depth MNKD or SNY have investigated it. You and others do not know if SNY shared the calculation and their research about this number with MNKD's management who were not involved in sales or marketing. And lastly, as this was a public statement from SNY about a matter of high concern to MNKD it is absurd to question that MNKD has at least read this statement that SNY gave tot the media.' It is a repetitive scheme to blame MNKD for poor sales, poor marketing or the lack of information MNKD published about sales of Afrezza. This is often an argument to attest underperformance of MNKD management. You could blame MNKD management for lack of product, bad product quality, an inferior product, lack of product pipeline etc, but blaming it for poor sales and marketing or poor communication about topics they are not allowed to communicate about is actually 'bashing'. Agree that SNY screwed up and is mainly to blame for poor marketing. However, I wonder what MNKD really knew and when. It is interesting to see how carefully Matt is avoiding a discussion of all these utterly wrong decisions at the moment (pricing, DTC campaign, not initiating labelling studies etc). Similarly, he is avoiding a discussion of the 65% drop-out argument entirely. Is it because he is still negotiating with SNY - or is it because we do not know some of the real issues yet? Remember how MNKD presented the clinical trial results. The trials were clearly flawed - real life Afrezza usage would be just wonderful! In a way it seems similar to me how the argument is put forth that if SNY had just lowered the price, everything would be great again. Maybe and hopefully so. But MNKD had been involved in all of these decisions in the past. They designed the trials together with the FDA, and they had representation in the SNY joint venture all along, too.
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Post by LosingMyBullishness on Apr 18, 2016 7:10:06 GMT -5
I also found your argument '..is something MNKD should have investigated and explained to shareholders.Is MNKD itself even aware of that statement by SNY?' again either rather ill-informed, naive or intentionally misleading: You and others here at the board do not know to what depth MNKD or SNY have investigated it. You and others do not know if SNY shared the calculation and their research about this number with MNKD's management who were not involved in sales or marketing. And lastly, as this was a public statement from SNY about a matter of high concern to MNKD it is absurd to question that MNKD has at least read this statement that SNY gave tot the media.' It is a repetitive scheme to blame MNKD for poor sales, poor marketing or the lack of information MNKD published about sales of Afrezza. This is often an argument to attest underperformance of MNKD management. You could blame MNKD management for lack of product, bad product quality, an inferior product, lack of product pipeline etc, but blaming it for poor sales and marketing or poor communication about topics they are not allowed to communicate about is actually 'bashing'. Agree that SNY screwed up and is mainly to blame for poor marketing. However, I wonder what MNKD really knew and when. It is interesting to see how carefully Matt is avoiding a discussion of all these utterly wrong decisions at the moment (pricing, DTC campaign, not initiating labelling studies etc). Similarly, he is avoiding a discussion of the 65% drop-out argument entirely. Is it because he is still negotiating with SNY - or is it because we do not know some of the real issues yet? Remember how MNKD presented the clinical trial results. The trials were clearly flawed - real life Afrezza usage would be just wonderful! In a way it seems similar to me how the argument is put forth that if SNY had just lowered the price, everything would be great again. Maybe and hopefully so. But MNKD had been involved in all of these decisions in the past. They designed the trials together with the FDA, and they had representation in the SNY joint venture all along, too. Thanks for your comment. I agree that MNKD management also did terrible mistakes on which they did not get into detail during CC (who would..). To me the reasons of these errors were a lack of business knowledge aka how to deal with cut-throats in Armani suits, a bit too much old-school business ethics, a bit of lab rat ignorance on drug roll-out and a huge amount of enthusiasm for the product. Nothing wrong with that, all very likable. The reasons for SNY to sandbag Afrezza are different as it is a VeryBP. They have some CorpGoverance guys and some generic apps where you have to get a certain score to show your business ethics (and you get funny questions if you reach 100% :-). On the involvement of MNKD in the periodical discussions with SNY: Yes, I wonder what Al said when he learnt about the pricing as he had stated in the past that Afrezza should be prices at par and that he expects SNY to do accordingly. I really wonder what MNKD management did when they left the conference room. If SNY gave several sound arguments for a premium price and can decide on the price, what do you do as MNKD management? You might believe that the decision is wrong, but how can you argue against such arguments? On the FDA trials: I believe that Al at that time was happy to get to the trials after all these delays and again I guess he was enthusiastic that despite being flawed they would still prove the superiority of Afrezza. "designing it together with..." is like "involved in all these decisions". We do not know how much MNKD had to say in the end. If the FDA insisted on comparing it with other prandial using the established way of dosing and timing to make it comparable, what do you do?
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Post by agedhippie on Apr 18, 2016 7:27:51 GMT -5
I would expect that Sanofi shared the results with Mannkind since I cannot see how the performance question wasn't asked given the sales. Either way Mannkind now have access to that data as part of the transition and can perform their own analysis. I seriously doubt the rationale will be disclosed any time soon since it is commercial sensitive - do you want your competitors to know where your weakness are? In their position I would not since I can see no upside to sharing it.
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Post by mnholdem on Apr 18, 2016 7:59:47 GMT -5
I would also expect that non-disclosure elements related to certain Sanofi business activities will be included in whatever termination settlement is signed between the two parties.
Frankly, if Afrezza sales grow significantly under MannKind's control over marketing, it will make Sanofi look bad regardless.
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Post by jerrys on Apr 18, 2016 10:03:00 GMT -5
I would expect that Sanofi shared the results with Mannkind since I cannot see how the performance question wasn't asked given the sales. Either way Mannkind now have access to that data as part of the transition and can perform their own analysis. I seriously doubt the rationale will be disclosed any time soon since it is commercial sensitive - do you want your competitors to know where your weakness are? In their position I would not since I can see no upside to sharing it. "I would expect that Sanofi shared the results with Mannkind..." I would too. Nevertheless, it would be reassuring to hear MNKD acknowledge that they had conversations with SNY somewhere along the way about the problems those diabetics had and why SNY couldn't cope with those problems. Moreover, MNKD maintains that it will now try to do what SNY couldn't, but how can you assess their capability or whether what they're doing is likely to be effective if you have no idea what made so diabetics leave to begin with?
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gc
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Post by gc on Apr 18, 2016 10:16:03 GMT -5
Regarding the % of patients who dropped A, the data is important but the reason is as important. Keep in mind during the initial rollout, while SNY sales forces provided sample packs to the doctors, there was encouragement from SNY to have doctors prescribe. It is possible that many of the patients who tried A were given the sample packs Rx for free or substantially reduced cost, but that cost would go up significantly due to poor or no insurance coverage and the cumbersome pre-authorization process required for insurance.
This data needs context and comparison to retention of Rx for other drug roll outs with a similar cost and insurance coverage to be understood. The timeline is also meaningful, is retention now different than originally? Is Rx retention related to insurance overage? I would not expect nor want MNKD to comment on this without meaningful statistics and a response that explains the reasons for the drop and that their plan going forward mitigates them.
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Post by daduke38 on Apr 18, 2016 12:32:36 GMT -5
Regarding the % of patients who dropped A, the data is important but the reason is as important. Keep in mind during the initial rollout, while SNY sales forces provided sample packs to the doctors, there was encouragement from SNY to have doctors prescribe. It is possible that many of the patients who tried A were given the sample packs Rx for free or substantially reduced cost, but that cost would go up significantly due to poor or no insurance coverage and the cumbersome pre-authorization process required for insurance. This data needs context and comparison to retention of Rx for other drug roll outs with a similar cost and insurance coverage to be understood. The timeline is also meaningful, is retention now different than originally? Is Rx retention related to insurance overage? I would not expect nor want MNKD to comment on this without meaningful statistics and a response that explains the reasons for the drop and that their plan going forward mitigates them. Would also like to see a breakdown of why the re-fill rate was low, no other way to put it. We should be in the 1000's of scripts just based on all the new scripts given out. My best guess is a combination of things. I believe all are fixable, but there has to be some % that just didn't like it. I would think it is a small %, but would be interested to know! My guess for the top 3 reasons were Cost, the pre-authorization for a script after the sample (cumbersome is the right word), and improper training to learn how to use the drug. Think we have all been guessing up to this point. Great post IMO!
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Post by lakon on Apr 18, 2016 12:32:41 GMT -5
Maybe I'm mistaken, but I thought that MNKD mentioned that they are looking into the dropout rate. They had ideas about it, but could/would not say definitively. I'd be happy with a 33% market share so at least there's that... Regarding mistakes along the way, both the FDA and SNY had final say with respect to trial design and marketing, respectively. It's the same argument. MNKD had limited options to deal with FDA trial design and SNY marketing. For this reason, I do not expect a superiority trial EVER, and I was happy to be rid of SNY. Now, I can short them [SNY] with impunity and not feel bad about it -- just unsure how to take a position against the FDA. BTW, superiority is not needed to WIN. It would be extremely difficult to prove under the current FDA, and it would be a further waste of resources. The long-term safety study should provide ample empirical evidence to garner support for Al Mann's hypothesis. Until that time, compete with the non-inferior RAA's.
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Post by tayl5 on Apr 18, 2016 16:08:20 GMT -5
Maybe I'm mistaken, but I thought that MNKD mentioned that they are looking into the dropout rate. They had ideas about it, but could/would not say definitively. I'd be happy with a 33% market share so at least there's that... Regarding mistakes along the way, both the FDA and SNY had final say with respect to trial design and marketing, respectively. It's the same argument. MNKD had limited options to deal with FDA trial design and SNY marketing. For this reason, I do not expect a superiority trial EVER, and I was happy to be rid of SNY. Now, I can short them [SNY] with impunity and not feel bad about it -- just unsure how to take a position against the FDA. BTW, superiority is not needed to WIN. It would be extremely difficult to prove under the current FDA, and it would be a further waste of resources. The long-term safety study should provide ample empirical evidence to garner support for Al Mann's hypothesis. Until that time, compete with the non-inferior RAA's. lakon, can you explain why you think a superiority trial won't be done? My impression is that the trial design required for approval was complicated by Afrezza being a new drug and thereby posing a risk to patients if used in a non-standard way. Tinfoil hat conspiracies aside, I'd like to think we've moved on from there and the next trial can be designed to highlight Afrezza's advantages.
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