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Post by Thundersnow on Nov 14, 2022 10:57:56 GMT -5
And you're not blaming Al Mann??? You blame Pfizer and Sanofi but you don't blame MNKD nor AL for not going the extra step(s) to make sure Afrezza would succeed against its competitors. I know he spent a ton of money plus the 2 CRLS and we all know he just wanted to get Afrezza approved. Well that will cost Afrezza a DECADE...... But its good for us LONGS bc we were able to add MNKD at lower prices!! I think if you follow my posts I am like a broken record saying the same thing over and over. What I have said many times is the biggest marketing mistake MNKD ever made was calling the cartridges "units". They should have been called small, med. and large. That is squarely on Al Mann. I understand why he did and at the time it seemed to make sense but hopefully Mike will change that with new packaging and a label change. Or, come out with a product for T1s and a separate one for T2s which might make more sense. As far as Pfizer and Sanofi I will go even further and point the finger at Brandicourt. Exubera was his baby at Pfizer and between afrezza and Januvia it went bust. Then he shows up at Sanofi and deep sixes afrezza day 1. Talk about MNKD being snake bit. As far as what MNKD got from the 175 study was superiority and a 14-0 vote at Adcom to approve. That was pretty damn good. Sanofi was then suppose to do phase 4 studies. Can you point me to one? Lets remember the big fear of insulin - hypoglycemia. During the 175 study to get approval if you can get superiority and still be conservative so not risking severe hypos that seems like the prudent thing to do. The phase 4 studies should then show the super-duper superiority. The problem now is the approved label needs updating. When was the last time it was updated? I think it would have better for us longs if afrezza realized Al Mann's belief five years ago and became the greatest selling drug of all time. There would not have been a split and the pps would be 100+. There would also be a lot of PWDs who would have already realized life changing care. I just love how you never answer the question and put your own spin on things. I give you credit. I'm pretty sure it was the FDA who TOLD Al Mann and MNKD to use UNITS and not SIZES for the cartridges. So basically that's a non issue. I believe if the previous Sanofi CEO was still in place things would have turned out differently. Sanofi would have followed through on their initial agreement and Afrezza would be further along in their life cycle. But it is what it is and we have what we have. Mike is doing a great job considering and has turned the company around. Now he needs to get to Wall Street and UPGRADE his investment community. It's time to move on from these 2nd tier players and move to the Big Boys. Maybe that will come when MNKD surpasses $5 per share. All in all MNKD has NEVER been stronger and finally has a solid growth plan. |
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Post by agedhippie on Nov 14, 2022 12:41:00 GMT -5
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Post by agedhippie on Nov 14, 2022 12:51:48 GMT -5
...I believe if the previous Sanofi CEO was still in place things would have turned out differently. Sanofi would have followed through on their initial agreement and Afrezza would be further along in their life cycle. ... At the time Sanofi were about to have Lantus go off patent and needed to get everyone switched over Toujeo to protect a major revenue stream. They needed Afrezza to be strong out of the gate because they couldn't afford the resources to fight on two fronts. Sanofi was definitely the best choice because their owned the also-ran in the RAA race, Apidra, so if Afrezza took off they were not losing a lot. Sanofi met their contractual obligations. What they didn't do is go beyond those obligations to do further trials that would have expanded the label. That may have been the CEO swap, it may have been the retention rates, but either way they didn't want to spend more money (they needed that for marketing Toujeo). Either way they never happened under Sanofi, and have not happened since. My feeling was that the old CEO would have given Afrezza the benefit of the doubt, but the new CEO with their experience of Exubera wouldn't. |
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Post by oldfishtowner on Nov 14, 2022 12:57:08 GMT -5
Exactly! A 33 participant proof of concept study just doesn't cut it for moving mountains. What makes anyone think that the ABC study will have any more impact than the STAT study? We all salivated over those results, too. Maybe the study moved the needle a bit, but it was not a monumental as you would think listening to the discussions here. Essentially MNKD did little follow-up to those results. |
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Post by Thundersnow on Nov 14, 2022 13:23:16 GMT -5
...I believe if the previous Sanofi CEO was still in place things would have turned out differently. Sanofi would have followed through on their initial agreement and Afrezza would be further along in their life cycle. ... At the time Sanofi were about to have Lantus go off patent and needed to get everyone switched over Toujeo to protect a major revenue stream. They needed Afrezza to be strong out of the gate because they couldn't afford the resources to fight on two fronts. Sanofi was definitely the best choice because their owned the also-ran in the RAA race, Apidra, so if Afrezza took off they were not losing a lot. Sanofi met their contractual obligations. What they didn't do is go beyond those obligations to do further trials that would have expanded the label. That may have been the CEO swap, it may have been the retention rates, but either way they didn't want to spend more money (they needed that for marketing Toujeo). Either way they never happened under Sanofi, and have not happened since. My feeling was that the old CEO would have given Afrezza the benefit of the doubt, but the new CEO with their experience of Exubera wouldn't. AGED....WHY did you mention a head to head with Mounjaro?  You played right into SAYHEY's hand.....LOL jk |
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Post by prcgorman2 on Nov 14, 2022 13:37:19 GMT -5
...I believe if the previous Sanofi CEO was still in place things would have turned out differently. Sanofi would have followed through on their initial agreement and Afrezza would be further along in their life cycle. ... At the time Sanofi were about to have Lantus go off patent and needed to get everyone switched over Toujeo to protect a major revenue stream. They needed Afrezza to be strong out of the gate because they couldn't afford the resources to fight on two fronts. Sanofi was definitely the best choice because their owned the also-ran in the RAA race, Apidra, so if Afrezza took off they were not losing a lot. Sanofi met their contractual obligations. What they didn't do is go beyond those obligations to do further trials that would have expanded the label. That may have been the CEO swap, it may have been the retention rates, but either way they didn't want to spend more money (they needed that for marketing Toujeo). Either way they never happened under Sanofi, and have not happened since. My feeling was that the old CEO would have given Afrezza the benefit of the doubt, but the new CEO with their experience of Exubera wouldn't. I couldn't have said it better myself. I know. I've tried. Perfect summary of history and reality.
The question is, how much does a 700+ person 5-year trial cost? We're coming up on 9 years past FDA approval, so it would have been good to have this done a long time ago. My assumption the reason it hasn't been done (yet?) is it's a big hill to take, and Castagna and Kendall knew it. Mike is tight with the purse strings (which I appreciate), but the 3 FDA approved sources of revenue (Tyvaso-DPI, V-Go, and Afrezza) may soon be able to foot the bill (as well as service debt, et cetera).
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Post by sayhey24 on Nov 14, 2022 13:46:28 GMT -5
Exactly! A 33 participant proof of concept study just doesn't cut it for moving mountains. What makes anyone think that the ABC study will have any more impact than the STAT study? We all salivated over those results, too. Maybe the study moved the needle a bit, but it was not a monumental as you would think listening to the discussions here. Essentially MNKD did little follow-up to those results. Because hope springs external. We have the 175 results, the STAT, the ABC, the 118 and next year India. Plus we have 7 years of clinical results and now we have CGMs. We don't need to wait years and have hundreds more showing the same results. Take 30 put half on afrezza and half on Mounjaro. Lets see what we get. Mike should be able to at least do that. Maybe Mounjaro has better post prandial control. I doubt it but lets see. If it works with 30 it will work with 3000. Unlike 5 years ago using AGP data is now mainstream and it takes all the guessing out of the equation. You don't need 780 people in the study so you can then try and guess what happened in the last 30 days. We can see and measure real time. Its a new game. During the call Mike talked about the new class URAA. That could have an impact but we will need to see. The ABC study should impact those discussions. Concerning STAT - what happened? You say "Essentially MNKD did little follow-up to those results". The freaking guy who did the study and was all excited - leaves flat. I still ask why did that guy leave the way he did after being so excited. Could he have moved the ball down the field by now - IDK but back before he left he said he could. |
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Post by sayhey24 on Nov 14, 2022 14:09:02 GMT -5
At the time Sanofi were about to have Lantus go off patent and needed to get everyone switched over Toujeo to protect a major revenue stream. They needed Afrezza to be strong out of the gate because they couldn't afford the resources to fight on two fronts. Sanofi was definitely the best choice because their owned the also-ran in the RAA race, Apidra, so if Afrezza took off they were not losing a lot. Sanofi met their contractual obligations. What they didn't do is go beyond those obligations to do further trials that would have expanded the label. That may have been the CEO swap, it may have been the retention rates, but either way they didn't want to spend more money (they needed that for marketing Toujeo). Either way they never happened under Sanofi, and have not happened since. My feeling was that the old CEO would have given Afrezza the benefit of the doubt, but the new CEO with their experience of Exubera wouldn't. AGED....WHY did you mention a head to head with Mounjaro? You played right into SAYHEY's hand.....LOL jk Aged - No one is saying Sanofi did not meet their "contractual" agreement. The gave us the 30 day notice and paid the fee. What they did not do is what needed to be done, what they sad they were going to do and what Steven Schwartz expected was going to be done. Instead Brandicourt comes in and shuts it down day 1. There was no way Brandicourt was going to help Al Mann. They came to the 2015 annual meeting and it was obvious they had no intention of doing what needed to be done. Granted the Toujeo launch was a disaster but that was another group. In the end what happened with Schwartz? Didn't they set him up with a ton of money to start Onduo. |
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Post by sayhey24 on Nov 14, 2022 14:39:14 GMT -5
I think if you follow my posts I am like a broken record saying the same thing over and over. What I have said many times is the biggest marketing mistake MNKD ever made was calling the cartridges "units". They should have been called small, med. and large. That is squarely on Al Mann. I understand why he did and at the time it seemed to make sense but hopefully Mike will change that with new packaging and a label change. Or, come out with a product for T1s and a separate one for T2s which might make more sense. As far as Pfizer and Sanofi I will go even further and point the finger at Brandicourt. Exubera was his baby at Pfizer and between afrezza and Januvia it went bust. Then he shows up at Sanofi and deep sixes afrezza day 1. Talk about MNKD being snake bit. As far as what MNKD got from the 175 study was superiority and a 14-0 vote at Adcom to approve. That was pretty damn good. Sanofi was then suppose to do phase 4 studies. Can you point me to one? Lets remember the big fear of insulin - hypoglycemia. During the 175 study to get approval if you can get superiority and still be conservative so not risking severe hypos that seems like the prudent thing to do. The phase 4 studies should then show the super-duper superiority. The problem now is the approved label needs updating. When was the last time it was updated? I think it would have better for us longs if afrezza realized Al Mann's belief five years ago and became the greatest selling drug of all time. There would not have been a split and the pps would be 100+. There would also be a lot of PWDs who would have already realized life changing care. I just love how you never answer the question and put your own spin on things. I give you credit. I'm pretty sure it was the FDA who TOLD Al Mann and MNKD to use UNITS and not SIZES for the cartridges. So basically that's a non issue. I believe if the previous Sanofi CEO was still in place things would have turned out differently. Sanofi would have followed through on their initial agreement and Afrezza would be further along in their life cycle. But it is what it is and we have what we have. Mike is doing a great job considering and has turned the company around. Now he needs to get to Wall Street and UPGRADE his investment community. It's time to move on from these 2nd tier players and move to the Big Boys. Maybe that will come when MNKD surpasses $5 per share. All in all MNKD has NEVER been stronger and finally has a solid growth plan. No it was not the FDA. It was Al Mann's idea. One of the biggest issues the Exubera users had was trying to get their conversion correct. Each dose blister contained 1 mg insulin human. T1s did units. This was listed as one of the biggest training issues. Al believed calling the cartridges units was going to make it so much easier for the PWD. The thing is afrezza is not like any other insulin. If it was not on the box and you were not told most people would have no idea it is insulin. So, whats the first thing doctors and T1s do - they see 4u and say wow thats a lot of insulin. Then after they take too little and under dose they say afrezza does not work. Then for the T2s - OMG its insulin. Insulin is dangerous, blah, blah blah. Agreed. MNKD has never been in a stronger financial position. However, we are not in a strong "community" position. It will be interesting to see what happens now that the expectation from BP that MNKD was going bankrupt is not going to happen. |
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Post by cppoly on Nov 14, 2022 16:15:55 GMT -5
Answering my own question and confusion aside (Mannkind press release says November 10th and no one around to help clarify), see the link below to watch the November 9th Mannkind Recording: www.diabetestechnology.org/dtm/free-sessions.shtmlEdit: this is not the ABC study presentation but is still a nice presentation. |
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Post by sayhey24 on Nov 14, 2022 17:57:28 GMT -5
Your link points to the presentation
Click the red button and go to 1:09:40
THURSDAY, NOVEMBER 10:
VIRTUAL POSTER SESSION Free Recording
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Post by agedhippie on Nov 14, 2022 21:27:47 GMT -5
Exactly! A 33 participant proof of concept study just doesn't cut it for moving mountains. What makes anyone think that the ABC study will have any more impact than the STAT study? We all salivated over those results, too. Maybe the study moved the needle a bit, but it was not a monumental as you would think listening to the discussions here. Essentially MNKD did little follow-up to those results. Because hope springs external. We have the 175 results, the STAT, the ABC, the 118 and next year India. Plus we have 7 years of clinical results and now we have CGMs. We don't need to wait years and have hundreds more showing the same results. ... The 175 trial was a standard phase 3 trial. Phase 3 is there to answer the question; can your drug outperform a sugar pill? If the answer is no (it's not superior) then it's game over and the drug is scrapped. The 175 and India trials are both phase 3 trial, and both will prove that Afrezza can out-perform a sugar pill. That's why those trials are discounted, same as the Januvia phase 3 trial was discounted. ABC and STAT are both far to small to be significant. Look at ABC vs. SURPASS-EARLY. If one person gets an incorrect result that throws that arm of the study out by 12% in the case of ABC, or 0.25% in the case of SURPASS for that data point. That's before we look at the effect of duration on smoothing errors. This is why ABC and STAT are discounted - just to small to be significant. Their use is in pointing to areas for larger trials. Lastly, there aren't 7 years of clinical results. There are 7 years of sales but unless someone can show me otherwise there is no data collected (although I suspect VDEX might have meaningful quantities of data)The problem with mass data is collection. This is why you see the data coming from countries with national health systems because they do have the data. The US system is utterly fragmented so unless you are a hub point like Medtronics who get to see the data from all their pumps and CGMs the data is mostly lost. While hope springs eternal, trial data is more reliable for changing medical opinion  |
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Post by uvula on Nov 14, 2022 21:34:52 GMT -5
I hope they don't really use sugar pills as the placebo in diabetes trials.
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Post by sayhey24 on Nov 15, 2022 7:28:12 GMT -5
I hope they don't really use sugar pills as the placebo in diabetes trials. Ha! Aged keeps saying that. The placebo was metformin alone or metformin plus 1 or 2 additional oral agents plus technosphere powder with no insulin. Oral agents included things like Januvia. Its pretty simple nothing is going to be better than pancreatic insulin post meal which it basically what we have with afrezza. The 175 trial was a good trial with the exception that afrezza was under dose. The good news is while it showed superiority we know it would have done even better if afrezza was properly dose. |
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Post by oldfishtowner on Nov 15, 2022 8:23:47 GMT -5
Exactly! A 33 participant proof of concept study just doesn't cut it for moving mountains. What makes anyone think that the ABC study will have any more impact than the STAT study? We all salivated over those results, too. Maybe the study moved the needle a bit, but it was not a monumental as you would think listening to the discussions here. Essentially MNKD did little follow-up to those results. Because hope springs external. We have the 175 results, the STAT, the ABC, the 118 and next year India. Plus we have 7 years of clinical results and now we have CGMs. We don't need to wait years and have hundreds more showing the same results. Take 30 put half on afrezza and half on Mounjaro. Lets see what we get. Mike should be able to at least do that. Maybe Mounjaro has better post prandial control. I doubt it but lets see. If it works with 30 it will work with 3000. Unlike 5 years ago using AGP data is now mainstream and it takes all the guessing out of the equation. You don't need 780 people in the study so you can then try and guess what happened in the last 30 days. We can see and measure real time. Its a new game. During the call Mike talked about the new class URAA. That could have an impact but we will need to see. The ABC study should impact those discussions. Concerning STAT - what happened? You say "Essentially MNKD did little follow-up to those results". The freaking guy who did the study and was all excited - leaves flat. I still ask why did that guy leave the way he did after being so excited. Could he have moved the ball down the field by now - IDK but back before he left he said he could. "Because hope springs eternal." This says it all. I appreciate your honesty and I agree with your assessment of Afrezza's potential, but as investors in MNKD we have all been living with hope for too long. Eternity is not for investing, its for preparing ourselves for the hereafter, and unfortunately, the pyramids notwithstanding, you cannot take your material wealth with you.
Also, unfortunately, we live in a era of evidence based medicine, which means relying on statistically significant clinical studies or the equivalent to determine the SOC. Since the approval of Afrezza, MNKD has played around with so-called proof-of-concept studies, but the pediatric study and the Cipla study are only large studies to be undertaken that are large enough to make a difference, both in terms of acceptance and MNKD's ability to make claims for effectiveness/superiority in marketing Afrezza. And we do not have the results of those studies yet. Everything else is basically anecdotal as far as the real world of medicine is concerned, where most practitioners are mediocre and follow the SOC.
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You played right into SAYHEY's hand.....LOL jk
