|
|
Post by longtimemnkd on Jan 9, 2016 10:56:29 GMT -5
Looks Dismal right now...if the New CEO is still onboard, and the CLAMP Studies (Post Approval) proved that AFrezza is faster than RAA insulins
Looks Really Dismal if.... New CEO doesn't take job and CLAMP Studies didn't prove improvement
A thought occurred to me:
Maybe Sanofi's plan was to change label using CLAMP studies....with improved Label they could get INsurance Formularies to approved "faster as shown in CLAMP studies" to Tier 2....they were waiting for the CLAMP studies...but when they came back, they didn't show the data they needed.
Now Sanofi had their new "Afrezza" marked up too high, had been telling insurance companies "CLAMP Results" coming, but then the REsults of the Clamp studies weren't favorable.
Someone should ask about the CLAMP studies (Results) at the JPM conference.....maybe Sanofi started to shut things down after getting the CLAMP studies results back...
Thoughts?
Believe me, I have invested my life savings and retirement....I believe in Al Mann and Afrezza....have been invested since the first Complete Response Letter.
I am worried right now.....about to lose it all....I made a mistake (Don't get too attached + diversify)
|
|
|
|
Post by peppy on Jan 9, 2016 11:26:33 GMT -5
Looks Dismal right now...if the New CEO is still onboard, and the CLAMP Studies (Post Approval) proved that AFrezza is faster than RAA insulins Looks Really Dismal if.... New CEO doesn't take job and CLAMP Studies didn't prove improvement A thought occurred to me: Maybe Sanofi's plan was to change label using CLAMP studies....with improved Label they could get INsurance Formularies to approved "faster as shown in CLAMP studies" to Tier 2....they were waiting for the CLAMP studies...but when they came back, they didn't show the data they needed. Now Sanofi had their new "Afrezza" marked up too high, had been telling insurance companies "CLAMP Results" coming, but then the REsults of the Clamp studies weren't favorable. Someone should ask about the CLAMP studies (Results) at the JPM conference.....maybe Sanofi started to shut things down after getting the CLAMP studies results back... Thoughts? Believe me, I have invested my life savings and retirement....I believe in Al Mann and Afrezza....have been invested since the first Complete Response Letter. I am worried right now.....about to lose it all....I made a mistake (Don't get too attached + diversify)
here is what I really think,
sanofi has their insulin franchise.
Look at what part of SNY is growing.
screencast.com/t/WS0UJOuNy
screencast.com/t/evIc92TidjI screencast.com/t/Tno2Hk8APs Pruluent and immune-oncology as well as their arthritis medicine are mono-clonal antibiodies. Sny diabetes plan screencast.com/t/lfvJnQwPlF5H minus afrezza.
My thoughts are the clamp studies are done. www.clinicaltrials.gov/ct2/show/results/NCT02470637 8 week part of pediatric trial should be done clinicaltrials.gov/ct2/show/NCT02527265?term=afrezza&recr=Open&no_unk=Y&rank=17
|
|
|
|
Post by harryx1 on Jan 9, 2016 11:33:01 GMT -5
I'll be first to admit that I was duped by Sanofi. Maybe I believe in the product too much as I couldn't see how they would drop such an amazing drug. If Apidra could do all the things that Afrezza can do, would they drop it? No, because they created it. It doesn't even come close to working as well as Afrezza does but that's what they are going with and it all comes down to money as Apidra won't eat into their basal drugs. Hindsight is 20/20 and it's becoming clearer each day on what their intentions were towards Afrezza. I apologize to all on the board that may have been influenced by any of my posts. I still have every share that I purchased and haven't sold one.
If the CLAMP studies failed to show a positive result then we have all been duped along with every Afrezza user too.
|
|
|
|
Post by dudley on Jan 9, 2016 12:04:03 GMT -5
Harry, there are no apologies required. I think 99.99% of us are stunned - I certainly did not see SNY walking and I think it will come back to haunt them in some way. Believing in Afrezza is easy - how can one NOT believe in a drug that has shown such incredible efficacy? The thing that surprises me most is the slow uptake. I'm a person who is always interested in a better mousetrap and more efficient ways to do things so Afrezza certainly lured me with the sleek and easy approach to insulin. When the non-diabetic type numbers started showing up it was clear this had game-changer potential. It mystifies me that diabetics are not camping outside their doctor's office to get this. Nobody can blame themselves for believing in the product, and of course Al Mann's track record speaks for itself. I've been as vocal a proponent as anyone else and I do not feel bad about it. I don't think the story is over, by a long shot. It IS hard to stay upbeat in the midst of all the relentless drumbeats of negativity but the core premise has not changed at all. Afrezza IS the best performing insulin ever developed, by a long shot. The market is gigantic and Al Mann is a proven winner. We are only 11 months into the "launch" and interest is worldwide. Just have to let the story play out.
|
|
|
|
Post by figglebird on Jan 9, 2016 12:13:23 GMT -5
Well said... Very genuine perspective.
Look, the narrative has always been tilted towards the perception of massive end of days type fear - it is totally understandable for even the most ardent longs to get that feeling of dread that reason typically shields them from.
That said, it is at times like these, that, although not necessarily indicative of something, I would personally feel reassured to see our new CEO's name on the website. Until that happens or until I feel reassured that nothing in that area has changed, I will be on edge.
C'Mon!
|
|
|
|
Post by greg on Jan 9, 2016 12:19:47 GMT -5
Harry, there are no apologies required. I think 99.99% of us are stunned - I certainly did not see SNY walking and I think it will come back to haunt them in some way. Believing in Afrezza is easy - how can one NOT believe in a drug that has shown such incredible efficacy? The thing that surprises me most is the slow uptake. I'm a person who is always interested in a better mousetrap and more efficient ways to do things so Afrezza certainly lured me with the sleek and easy approach to insulin. When the non-diabetic type numbers started showing up it was clear this had game-changer potential. It mystifies me that diabetics are not camping outside their doctor's office to get this. Nobody can blame themselves for believing in the product, and of course Al Mann's track record speaks for itself. I've been as vocal a proponent as anyone else and I do not feel bad about it. I don't think the story is over, by a long shot. It IS hard to stay upbeat in the midst of all the relentless drumbeats of negativity but the core premise has not changed at all. Afrezza IS the best performing insulin ever developed, by a long shot. The market is gigantic and Al Mann is a proven winner. We are only 11 months into the "launch" and interest is worldwide. Just have to let the story play out. While agreeing with most of what you said, I would also point out the following: First, you can build a better mousetrap but if nobody knows about it, it's not going to sell. Second, even if folks know about it, not many people will pay a huge premium for that better mousetrap when there's a decent far cheaper alternative. In the case of Afrezza, Sanofi's advertising efforts were abysmal. Possibly even worse, given their pricing strategy, diabetics had to pay almost 10-times more out-of-pocket for Afrezza. So, the slow uptake is not really surprising. |
|
|
|
Post by tbone on Jan 9, 2016 12:22:01 GMT -5
He is listed as a presenter at this coming week's presentation.
|
|
|
|
Post by figglebird on Jan 9, 2016 12:22:42 GMT -5
Not worried about the clamp studies - irispective of what they showed - they were done under Sanofi's watch and IF they did under achieve Mannkind can roll it into their evidence etc... for me, at this moment I need confirmation that Duane Desisto is taking the reigns.
If I am to believe that Al forced Sanofi out with threat of breach, I would also have to believe that Duane would have been aware and prepared - on the other hand...
Matt's response that his expectation is that he will be at JPM is a strange one or at least felt strange under these circumstances - I have a tendency of misreading things or looking for answers that are not there so I am purposefully trying not to speculate - I just need reconfirmation.
It would go a long way.
|
|
|
|
Post by figglebird on Jan 9, 2016 12:25:22 GMT -5
Where? On the press release? If so, this was issued prior to the termination letter. Not saying he will not be there, just need a little reassurance from time to time - I can stomach the rest and maintain my own bullish view, on everything else.
|
|
|
|
Post by tbone on Jan 9, 2016 12:29:42 GMT -5
Where? On the press release? If so, this was issued prior to the termination letter. Not saying he will not be there, just need a little reassurance from time to time - I can stomach the rest and maintain my own bullish view, on everything else. Yes, on PR from before. Nothing about the presentation on site other than that. |
|
|
|
Post by stevil on Jan 9, 2016 12:40:30 GMT -5
Harry, like Dudley said, no apologies needed. We're all responsible for the decisions we made. I haven't been on this board as long as others, but you've brought a lot of good info to this board from what I've seen. You never intentionally misled any of us, and as far as I know, never shared false information. You simply shared what you thought was valuable and passed it along. It's on us at that point to analyze material, form an opinion, then make a decision and carry it out.
Regardless of what the clamp studies show, I believe Spiro, blindhog, Sam, afrezza user, Matt, and any other Afrezza patient has been genuine in their information sharing. I can't imagine the CLAMP studies come back inconclusive or non superior after watching Matt's Coke challenge. You just can't do that with an injectable unless you time and dose it perfectly. I don't care what the studies say (unless one comes out showing increased lung cancer... then... damn) because, if nothing else, inhaled monomeric human insulin is the safest, quickest, and healthiest way to take insulin that we've created. I liken it to eating fruits and vegetables vs taking vitamins for nutrition. I trust the diabetics that say they feel better on Afrezza. They feel like they have their life back. I'll be shocked if the clamp studies don't come back positively.
I don't hang my head for the decision I made on Afrezza. I made up my mind what I thought the risk vs reward was and I thought the reward was favorable to the odds. If I keep taking these kinds of risks on drugs like Afrezza in my lifetime, all I'll need is to get one right and as long as I'm careful with not over investing, I'll still come out ahead in the end. From the sound of it, the biggest mistake I have seen on this board wasn't in investing in Afrezza, it was the amount of the investment in Afrezza. We somehow convinced ourselves that this was a sure thing and didn't consider that we might lose all of it. Patryn, a poster I respected a lot, posited that at the very least Afrezza would recoup in the $4-5 range in a buyout if SNY dropped us. We never even seriously considered that bankruptcy was an option and that no one else would want to purchase us or any other TS application. It's still disturbing to me that we've heard talk of potential partners for years and have yet to have formed a partnership. It took FDA approval to get a partner the first time. It's unfortunate that we're ahead of our time and no one wants to be the first to take the risk. I'd so much rather inhale my medicine than swallow it. Especially after seeing my 96 year old grandfather nearly choke every time he tries to take his pills because he has difficulty swallowing in his later years.
|
|
|
|
Post by slugworth008 on Jan 9, 2016 12:51:36 GMT -5
Harry, there are no apologies required. I think 99.99% of us are stunned - I certainly did not see SNY walking and I think it will come back to haunt them in some way. Believing in Afrezza is easy - how can one NOT believe in a drug that has shown such incredible efficacy? The thing that surprises me most is the slow uptake. I'm a person who is always interested in a better mousetrap and more efficient ways to do things so Afrezza certainly lured me with the sleek and easy approach to insulin. When the non-diabetic type numbers started showing up it was clear this had game-changer potential. It mystifies me that diabetics are not camping outside their doctor's office to get this. Nobody can blame themselves for believing in the product, and of course Al Mann's track record speaks for itself. I've been as vocal a proponent as anyone else and I do not feel bad about it. I don't think the story is over, by a long shot. It IS hard to stay upbeat in the midst of all the relentless drumbeats of negativity but the core premise has not changed at all. Afrezza IS the best performing insulin ever developed, by a long shot. The market is gigantic and Al Mann is a proven winner. We are only 11 months into the "launch" and interest is worldwide. Just have to let the story play out. If the majority of diabetics knew about Afrezza - They would be camping outside of their doctors offices to get it - Therein lies the real issue. No doubt it's hard to stay upbeat - But we must endeavor to persevere (Outlaw Josey Wales quote). I'm glad SNY is gone and looking forward to seeing what DeSisto can do! |
|
|
|
Post by stevil on Jan 9, 2016 13:13:08 GMT -5
If the majority of diabetics knew about Afrezza - They would be camping outside of their doctors offices to get it - Therein lies the real issue. No doubt it's hard to stay upbeat - But we must endeavor to persevere (Outlaw Josey Wales quote). I'm glad SNY is gone and looking forward to seeing what DeSisto can do! How many diabetics do you think HAVE heard about Afrezza? Keep in mind, it has been featured in (someone correct me if I'm wrong) densely populated areas on the east coast during news broadcasts. It has been published in magazine periodicals (with millions of diabetic (assumption) subscribers and then having to assume they see that ad in the magazine), prominent internet bloggers with upwards of 10,000 diabetic (assumption) followers have written about it, all the work Eric Fenar and Sam Finta have been doing, etc. I don't think marketing is the issue at this time as 15,000 scripts is a paltry number compared to the number of diabetics who have likely already heard about Afrezza. This is just my opinion, of course, as I don't know the number of people who want Afrezza and can't get it either because it's too expensive, or their physician won't prescribe it. However, I'm beginning to think that if we will have success with Afrezza that it will start with winning physicians over. And that will start with studies that will convince physicians why their patient MUST have Afrezza. Hopefully MNKD knows what the biggest roadblocks are so they can correctly allocate their remaining funds to fixing those issues. It kind of makes the most sense to me to target the docs right now as that should give you the most bang for your buck. Each physician should have a minimum of a few thousand patients in their practice. I also don't think that diabetics care about Afrezza as much as we think they should. To the average Joe, it's just inhaled insulin until we're allowed to call it inhaled insulin that's better and faster than any other insulin. That won't happen until studies confirm it. Total NRx's= somewhere around 15,000 according to peppy's chart here mnkd.proboards.com/post/56589 |
|
|
|
Post by factspls88 on Jan 9, 2016 13:58:09 GMT -5
If the majority of diabetics knew about Afrezza - They would be camping outside of their doctors offices to get it - Therein lies the real issue. No doubt it's hard to stay upbeat - But we must endeavor to persevere (Outlaw Josey Wales quote). I'm glad SNY is gone and looking forward to seeing what DeSisto can do! How many diabetics do you think HAVE heard about Afrezza? Keep in mind, it has been featured in (someone correct me if I'm wrong) densely populated areas on the east coast during news broadcasts. It has been published in magazine periodicals (with millions of diabetic (assumption) subscribers and then having to assume they see that ad in the magazine), prominent internet bloggers with upwards of 10,000 diabetic (assumption) followers have written about it, all the work Eric Fenar and Sam Finta have been doing, etc. I don't think marketing is the issue at this time as 15,000 scripts is a paltry number compared to the number of diabetics who have likely already heard about Afrezza. This is just my opinion, of course, as I don't know the number of people who want Afrezza and can't get it either because it's too expensive, or their physician won't prescribe it. However, I'm beginning to think that if we will have success with Afrezza that it will start with winning physicians over. And that will start with studies that will convince physicians why their patient MUST have Afrezza. Hopefully MNKD knows what the biggest roadblocks are so they can correctly allocate their remaining funds to fixing those issues. It kind of makes the most sense to me to target the docs right now as that should give you the most bang for your buck. Each physician should have a minimum of a few thousand patients in their practice. I also don't think that diabetics care about Afrezza as much as we think they should. To the average Joe, it's just inhaled insulin until we're allowed to call it inhaled insulin that's better and faster than any other insulin. That won't happen until studies confirm it. Total NRx's= somewhere around 15,000 according to peppy's chart here mnkd.proboards.com/post/56589I live in the NYC metro area and I have not seen one Afrezza ads. The print ones I saw posted online were abysmal and I stated as such. I have a great deal of experience in advertising evaluation and new product introduct so I know what I'm talking about. I was holding out for TV ads to make me feel better about their media and advertising stratey but clearly that wasn't a smart thing to do in hindsight. In contrast, I saw at least 10 Toujeo ads and I don't even watch that much TV. |
|
|
|
Post by stevil on Jan 9, 2016 14:33:28 GMT -5
How many diabetics do you think HAVE heard about Afrezza? Keep in mind, it has been featured in (someone correct me if I'm wrong) densely populated areas on the east coast during news broadcasts. It has been published in magazine periodicals (with millions of diabetic (assumption) subscribers and then having to assume they see that ad in the magazine), prominent internet bloggers with upwards of 10,000 diabetic (assumption) followers have written about it, all the work Eric Fenar and Sam Finta have been doing, etc. I don't think marketing is the issue at this time as 15,000 scripts is a paltry number compared to the number of diabetics who have likely already heard about Afrezza. This is just my opinion, of course, as I don't know the number of people who want Afrezza and can't get it either because it's too expensive, or their physician won't prescribe it. However, I'm beginning to think that if we will have success with Afrezza that it will start with winning physicians over. And that will start with studies that will convince physicians why their patient MUST have Afrezza. Hopefully MNKD knows what the biggest roadblocks are so they can correctly allocate their remaining funds to fixing those issues. It kind of makes the most sense to me to target the docs right now as that should give you the most bang for your buck. Each physician should have a minimum of a few thousand patients in their practice. I also don't think that diabetics care about Afrezza as much as we think they should. To the average Joe, it's just inhaled insulin until we're allowed to call it inhaled insulin that's better and faster than any other insulin. That won't happen until studies confirm it. Total NRx's= somewhere around 15,000 according to peppy's chart here mnkd.proboards.com/post/56589I live in the NYC metro area and I have not seen one Afrezza ads. The print ones I saw posted online were abysmal and I stated as such. I have a great deal of experience in advertising evaluation and new product introduct so I know what I'm talking about. I was holding out for TV ads to make me feel better about their media and advertising stratey but clearly that wasn't a smart thing to do in hindsight. In contrast, I saw at least 10 Toujeo ads and I don't even watch that much TV. That's fair. Look, I'm not saying that SNY did a good job marketing Afrezza. All I'm saying is that they did enough, in my opinion, to have more than 15k scripts. We keep wanting the ads to get better, but MNKD isn't going to be able to say anything more in them than SNY did. They'll be able to say that it's a rapid acting insulin and that it's fast. It's inhaled. That's pretty much it. If they get into the scientific jargon, it will be lost on people as they won't understand what it means or why it's significant. Here are a few examples of all the things SNY DIDN'T do as well as what was said about Afrezza on the news and elsewhere. In today's day and age, if you're interested in something you hear about, you can go onto the internet and look it up. Most people have their smartphones in front of them at all times and do it right away. My argument is that I think far greater than 100k diabetics (honestly I'd say close to a million if I knew I wouldn't get crucified for doing so) have already heard about Afrezza. That doesn't mean they understand it, it just means they've heard about it. Again, even if we could make what we think are rightful claims about Afrezza, we're still restricted by our label and a 30 second ad wouldn't be able to educate diabetics as to why Afrezza would truly be superior. I think the Toujeo ads are awful also and they're not even handcuffed. If I was diabetic, it'd be just another drug to me. Nothing stated in the commercial distinguishes it from any other diabetic drug. But that's all it's supposed to do. It's just supposed to get patients in the doctor's office to ask about the drug so the doctor can decide if it's right for them. That's why I contended that our fight should start first with doctors. www.youtube.com/watch?v=PefXkzTjugY- from our very own EOTD's youtube channel www.youtube.com/watch?v=8EuuDj26bX8www.youtube.com/watch?v=pCtTvNqj9TA- this has 36,000 views alone, great exposure. www.youtube.com/watch?v=wZj4JwqJBmM |
|
