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Post by Deleted on May 12, 2016 14:14:42 GMT -5
the doc office which had your dad on Afrezza still prescribing Afrezza? or did they put a pause..? they should have seen the results first hand We were the only patient they had on Afrezza and we asked for it. The nurse coordinator was positive and I shared everything I knew with her. The problems were with the docs who didn't understand Afrezza and wouldn't raise the dose. Afrezza is not the same dose for dose as injectable.. My dad had excellent results, his numbers were about the same as when on injectable, but could have been better had they raised the dose. You can raise the dose with Afrezza and get better numbers with less risk of hypo... He had no hypo while on Afrezza.. he also lost 24lbs in 5 months... and his blood pressure dropped as well .. He ended up having to go off of it because his insurance removed it from their formulary. He was frankly fed up with all of the hoops he had to jump through to be on this drug... so he quit.. but the minute he can go back on he will.
I don't know that we gained that much traction with impressing the docs... he was just one of many patients and they didn't take Afrezza that seriously to begin with. But I do think the nurse coordinator we were seeing understood what Afrezza was, so we may have gained some points with her. Its funny how people are, they seem to want to wait and see what everyone else is saying and doing before they try something. One doc we saw was waiting for the price to drop and better insurance coverage. Its a mixed bag of issues we have to overcome, but I believe Matt is on the right track. SNY didn't seem to care much... MNKD does.
well did you try talking to the doc with the results and getting his feedback? 5 months on Afrezza, 24 lb weight loss, lowered BP should have gotten you some where in the conversation...and the doc on board.. if the doc hasnt - time to change
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Post by ilovekauai on May 12, 2016 14:15:26 GMT -5
Call me wrong, but I'm jazzed over the hire of the CCO, Michael C. He has what it takes to oversee the entire marketing plan, as well as the NE effort. He will motivate those new reps to get out in the field later this year to sell Afrezza, dancing circles around Sanofi's paltry marketing effort. Exactly what the Dr. has ordered! And IMO, Matt will be relieved to finally have this launched. I've been very impressed with him, and feel good about new senior management now in place. Let's be patient, persevere, and give MNKD a chance to show us investors what they can do on their own. Heck, I've waited this long and what's another year? This is really huge and gutsy when you think about it. I admire that. Fingers crossed!
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Post by edvarney on May 12, 2016 15:21:22 GMT -5
I believe in regards to the finalizing date with Sanofi; it is obviously open date yet. and it is to be determined by MNKD! So, knowing that we have about 170 mil. unused from the Sanofi Loan yet, I believe Matt plans to use as much of it as possible. It is unstated anywhere here, but I expect Matt has no plans in the future to pay Sanofi back for anything in this deal. If anything, they will still owe MNKD longterm for all the damage they created for Afrezza marketing!!! Just my opinion of course
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Post by Deleted on May 12, 2016 15:39:40 GMT -5
I believe in regards to the finalizing date with Sanofi; it is obviously open date yet. and it is to be determined by MNKD! So, knowing that we have about 170 mil. unused from the Sanofi Loan yet, I believe Matt plans to use as much of it as possible. It is unstated anywhere here, but I expect Matt has no plans in the future to pay Sanofi back for anything in this deal. If anything, they will still owe MNKD longterm for all the damage they created for Afrezza marketing!!! Just my opinion of course That line of credit is closed when the contract terminated. It's not available for Matt to spend. It's for Sanofi to spend
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Post by lakers on May 12, 2016 15:44:41 GMT -5
Here is the exact quote from Matt regarding the offering. .. "were very careful in placing the new shares with a few select investors, which is important to existing shareholders" Ok, so I don't really like reading into things that Matt says (well anyone from MNKD really), but I'm going to take a shot on this one anyways... Any chance Matt said this because he was talking about only selling these new shares to investors who won't lend them out to be shorted? That's the only thing I can think of as to why WHO he is selling to would be important to existing shareholders. Thoughts? IMHO, Mnkd likely sold shares to RLS' investors as they have a vested interest to see Mnkd survives. Once their identity is revealed, we can figure out who RLS is. If RLS' Technosphere drugs show great result, a reverse merge may happen to save tax for both cos.
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Post by Deleted on May 12, 2016 15:53:54 GMT -5
Ok, so I don't really like reading into things that Matt says (well anyone from MNKD really), but I'm going to take a shot on this one anyways... Any chance Matt said this because he was talking about only selling these new shares to investors who won't lend them out to be shorted? That's the only thing I can think of as to why WHO he is selling to would be important to existing shareholders. Thoughts? IMHO, Mnkd likely sold shares to RLS' investors as they have a vested interest to see Mnkd survives. Once their identity is revealed, we can figure out who RLS is. If RLS' Technosphere drugs show great result, a reverse merge may happen to save tax for both cos. Its unfortunate because you could kinda figure out if the shares really were in good hands if Als shares were not being sold. If Als shares are being sold its impossible to know if these"investors" really have our backs"
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Post by LosingMyBullishness on May 12, 2016 16:08:44 GMT -5
Nothing is stopping them, they are starting with nursing educators this month, producing different options of samples so they better fit the needs of the different patients, and the sales force will be hitting the pavement very soon, next month I believe. There has to be organization and training for these sales people, you can't just give them an afrezza t-shirt and throw them to the wolves. Matt said more than once, thing were coming together at record pace, right ?? you are misreading my post. Me reply of "whats stopping them to do now? its not like mannkind is coming with next version with Afrezza" was to question Scott's comment "When Matt referred to input from key doctors there are some significant ones that are Afrezza fans. They alone have the potential to move the needle in terms of Rx counts. " Good point. Who are these key doctors that are enthusiastic but have little effect on scripts. What makes them 'key' ?
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Post by mnkdnut on May 12, 2016 17:33:01 GMT -5
I am both relieved and annoyed that we now hear all this attention paid to proper on-boarding of new Afrezza patients: Relieved because unless you have a reliable process to enable new patients to get the true benefits of the product, nothing else really matters. Expensive Trials to demonstrate benefit over RAAs would likely fail due to sub-optimal use of Afrezza and high drop-out rate. It would be more money wasted and opportunity lost - perhaps permanently. Now at least we build off a foundation where superiority studies can realistically be contemplated. I believe a dedicated Mannkind sales and clinical support force will make a world of difference compared to SNY, albeit with much smaller footprint. Annoyed because this issue is as old as the FDA trials, and only recently we are hearing recognition that it needs addressing? As I recall, the FDA was quite concerned about how to factor in the high drop-out rate of Afrezza patients in the Trials compared to the RAA group. And, how many new starter-pack patients did Sanofi let slip away with their "give it a try, let's see what happens" approach to on-boarding? 30+%? Can't blame them all on reimbursement! If the patient is not experiencing the benefit early on, reimbursement is irrelevant to their continuing! There's no excuse for Sanofi not knowing early-on this was going to be an issue and coming up with a way to address it - but then again, they weren't committed at the top because Brandicourt never bought in.
As a side note, I recently heard about the launch tactics of Toyota's new Hydrogen powered car, the Mirai. Revolutionary technology, but not well understood. Their marketers decided to hand-pick the first 150 customers (from a pool of applicants), and limit release to that group until they could assure every one of them was having as great an experience with the car as possible. These customers receive comprehensive and personal support to iron out any wrinkles, while Toyota learns what it takes to deliver the great experience. They know the strategic benefit of not botching the launch of a paradigm shifting technology. Very smart.
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Post by agedhippie on May 12, 2016 17:39:13 GMT -5
Ok, so I don't really like reading into things that Matt says (well anyone from MNKD really), but I'm going to take a shot on this one anyways... Any chance Matt said this because he was talking about only selling these new shares to investors who won't lend them out to be shorted? That's the only thing I can think of as to why WHO he is selling to would be important to existing shareholders. Thoughts? IMHO, Mnkd likely sold shares to RLS' investors as they have a vested interest to see Mnkd survives. Once their identity is revealed, we can figure out who RLS is. If RLS' Technosphere drugs show great result, a reverse merge may happen to save tax for both cos. There are not topflight investors which is why the phrase 'select investors' entertains me so much. Mannkind paid Rodman & Renshaw $2.5M precisely because of their ability to shift high risk stock. Rodman & Renshaw criteria for a 'select investor' is that they have a checkbook and understand how to make a quick buck. Those investors are Rodman & Renshaw's real clients, Mannkind is just today's dinner. In fairness in their current position I don't believe Matt had much option - there are no assets to secure a loan, and the stock is high risk. In these situations the bottom feeders your only option. Just lets not pretend the investors are in this for anything other than a short term trade.
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Post by agedhippie on May 12, 2016 17:47:06 GMT -5
Annoyed because this issue is as old as the FDA trials, and only recently we are hearing recognition that it needs addressing? As I recall, the FDA was quite concerned about how to factor in the high drop-out rate of Afrezza patients in the Trials compared to the RAA group. And, how many new starter-pack patients did Sanofi let slip away with their "give it a try, let's see what happens" approach to on-boarding? 30+%? Can't blame them all on reimbursement! If the patient is not experiencing the benefit early on, reimbursement is irrelevant to their continuing! There's no excuse for Sanofi not knowing early-on this was going to be an issue and coming up with a way to address it - but then again, they weren't committed at the top because Brandicourt never bought in. A better question is why four months after ADCOM and a year after the end of trials Mannkind signed the deal with Sanofi but still had not worked out how to dose Afrezza. Sorry, but if that screw up falls to anyone it is Mannkind.
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Post by LosingMyBullishness on May 12, 2016 18:59:44 GMT -5
I liked Matt's presentation and did find him pretty focussed. He sounded a bit short-winded but he has a tough schedule.
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Post by mnholdem on May 12, 2016 20:04:07 GMT -5
Annoyed because this issue is as old as the FDA trials, and only recently we are hearing recognition that it needs addressing? As I recall, the FDA was quite concerned about how to factor in the high drop-out rate of Afrezza patients in the Trials compared to the RAA group. And, how many new starter-pack patients did Sanofi let slip away with their "give it a try, let's see what happens" approach to on-boarding? 30+%? Can't blame them all on reimbursement! If the patient is not experiencing the benefit early on, reimbursement is irrelevant to their continuing! There's no excuse for Sanofi not knowing early-on this was going to be an issue and coming up with a way to address it - but then again, they weren't committed at the top because Brandicourt never bought in. A better question is why four months after ADCOM and a year after the end of trials Mannkind signed the deal with Sanofi but still had not worked out how to dose Afrezza. Sorry, but if that screw up falls to anyone it is Mannkind. Is that a fair assessment? Prior to ADCOM & the subsequent FDA approval, patients' use of Afrezza was restricted by strict protocols imposed by the FDA. MannKind was never free to provide Afrezza to the patient-at-large, unless you count the few months after between April - August while they were negotiating the License & Collaboration Agreement with Sanofi. If anyone is to blame it's Sanofi, who had 100% of the responsibility (and accountability) for development. If MannKind shares any blame, then perhaps it would be falling for the assurances by Sanofi that they would know what to do AND for signing away 100% of the decision-making authority, for which I would have fired MannKind's corporate attorney (unless Thomsen warned the Al/BoD not to accept that condition and was overruled). Afrezza is so unique in its physiological properties that it is unlike any other insulin...ever! Sanofi either failed to realize the uniqueness of Afrezza or they chose to ignore/suppress it. Regardless, Sanofi began market development and patient training as if Afrezza were just a faster insulin. They totally missed the boat on endocrinologists rarely using spirometry equipment and then over-priced Afrezza, again (depending on their intent) either because they naively thought Afrezza would simply fly off the shelves or to ensure that this disruptive insulin remain on the shelf to gather dust.
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Post by brotherm1 on May 12, 2016 21:04:44 GMT -5
IMHO, Mnkd likely sold shares to RLS' investors as they have a vested interest to see Mnkd survives. Once their identity is revealed, we can figure out who RLS is. If RLS' Technosphere drugs show great result, a reverse merge may happen to save tax for both cos. There are not topflight investors which is why the phrase 'select investors' entertains me so much. Mannkind paid Rodman & Renshaw $2.5M precisely because of their ability to shift high risk stock. Rodman & Renshaw criteria for a 'select investor' is that they have a checkbook and understand how to make a quick buck. Those investors are Rodman & Renshaw's real clients, Mannkind is just today's dinner. In fairness in their current position I don't believe Matt had much option - there are no assets to secure a loan, and the stock is high risk. In these situations the bottom feeders your only option. Just lets not pretend the investors are in this for anything other than a short term trade. You know for a fact that the investors are Rodman and Renshaw or are you guessing?
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Post by agedhippie on May 12, 2016 21:44:03 GMT -5
There are not topflight investors which is why the phrase 'select investors' entertains me so much. Mannkind paid Rodman & Renshaw $2.5M precisely because of their ability to shift high risk stock. Rodman & Renshaw criteria for a 'select investor' is that they have a checkbook and understand how to make a quick buck. Those investors are Rodman & Renshaw's real clients, Mannkind is just today's dinner. In fairness in their current position I don't believe Matt had much option - there are no assets to secure a loan, and the stock is high risk. In these situations the bottom feeders your only option. Just lets not pretend the investors are in this for anything other than a short term trade. You know for a fact that the investors are Rodman and Renshaw or are you guessing? I did not say that Rodman and Renshaw were the investors, I said they were shifting the stock. That's why companies in Mannkind's position use them, because they have a following who will take risky stock if it is cheap enough to flip. Am I guessing? No, I'm correct or the SEC are going to be having a stiff word with Mannkind about their press release ( link here). If you want to know more about how they operate Matt wrote a good summary here when this was first announced.
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Post by agedhippie on May 12, 2016 21:56:53 GMT -5
A better question is why four months after ADCOM and a year after the end of trials Mannkind signed the deal with Sanofi but still had not worked out how to dose Afrezza. Sorry, but if that screw up falls to anyone it is Mannkind. Is that a fair assessment? Prior to ADCOM & the subsequent FDA approval, patients' use of Afrezza was restricted by strict protocols imposed by the FDA. MannKind was never free to provide Afrezza to the patient-at-large, unless you count the few months after between April - August while they were negotiating the License & Collaboration Agreement with Sanofi. If anyone is to blame it's Sanofi, who had 100% of the responsibility (and accountability) for development. If MannKind shares any blame, then perhaps it would be falling for the assurances by Sanofi that they would know what to do AND for signing away 100% of the decision-making authority, for which I would have fired MannKind's corporate attorney (unless Thomsen warned the Al/BoD not to accept that condition and was overruled). Afrezza is so unique in its physiological properties that it is unlike any other insulin...ever! Sanofi either failed to realize the uniqueness of Afrezza or they chose to ignore/suppress it. Regardless, Sanofi began market development and patient training as if Afrezza were just a faster insulin. They totally missed the boat on endocrinologists rarely using spirometry equipment and then over-priced Afrezza, again (depending on their intent) either because they naively thought Afrezza would simply fly off the shelves or to ensure that this disruptive insulin remain on the shelf to gather dust. My feeling is that after a series of trials Mannkind should have known what the PK/PD looked like and how to dose. You had people like Sam who I thought had worked out how to dose by the trial end. They should have talked to the patients who got good results to find why they did well and others did badly. On a deal like this would they rely on their corporate counsel and had external counsel as well? I know on anything like this we would want external counsel for liability reasons. I do agree that the loss of control was killing although in fairness they had the Sanofi CEO on-board they may have thought the risk was acceptable. One day it would be nice to know how that all went down.
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