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Post by bthomas55ep on Oct 25, 2016 17:40:18 GMT -5
Didn't Matt indicate they were going to submit an application for label change by the end of Sept?
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Post by Deleted on Oct 25, 2016 17:44:32 GMT -5
Didn't Matt indicate they were going to submit an application for label change by the end of Sept? And pediatric protocol too... well he also said many things. So just stay tuned |
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Post by rockstarrick on Oct 25, 2016 22:40:02 GMT -5
If I was Matt, after listening to all the smart ass remarks that float around anytime he opens his mouth, I wouldn't say sh-t !! Not a single word until the law required it.
My comment isn't directed specifically at anybody, but this game of complaining about transparency, and then using every thing he says against him to make him look incompetent really gets old.
It's really easy to sit on the sidelines and chearlead about how to make this thing work, it's a whole different ballgame if you're Matt.
If I had the opportunity to choose between Matt or any of the people flapping their jaws about him, I'd choose Matt by a mile.
The End !
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Post by sophie on Oct 26, 2016 1:28:56 GMT -5
If I was Matt, after listening to all the smart ass remarks that float around anytime he opens his mouth, I wouldn't say sh-t !! Not a single word until the law required it. My comment isn't directed specifically at anybody, but this game of complaining about transparency, and then using every thing he says against him to make him look incompetent really gets old. It's really easy to sit on the sidelines and chearlead about how to make this thing work, it's a whole different ballgame if you're Matt. If I had the opportunity to choose between Matt or any of the people flapping their jaws about him, I'd choose Matt by a mile. The End ! It's one thing to be transparent, especially after promising as much. It's a whole other situation when you sound like a snake oil salesman, giving fluffy answers and indirect answers to allow hope to remain in absence of clarity. I don't blame the guy for doing what he does. He's a CEO that needs to try to keep the share price up if he needs to dilute. But neither am I a fan of either his leadership or conference call demeanor. The first thing anyone will tell you that runs a business is never to overpromise and underdeliver. It seems that's all Matt does. I would just as soon ask him not to share anything instead of pumping us full of hopium. Of course, being honest and telling us what really was going on the past few years wouldn't have been a bad start either. If he had, we probably would have been much more prepared for this share price. Instead, we're still wondering if there is or ever was a plan or if he's just been stalling this whole time while trying to figure one out. I'll take an outlined plan over an embarrassment of riches any day |
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Post by dictatorsaurus on Oct 26, 2016 7:59:22 GMT -5
Is it too much to ask for a CEO of a publicly traded company to deliver what they said they would?
They claimed they will be more transparent with MMannkind two point 0. Can anyone honestly say they've been transparent with anything?
He made so many promises and up until now has proven to be a major failure. You can only play the "nice guy" role for so long.
I'm actually surprised longs aren't coming down on him much harder.
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Post by nadathing on Oct 26, 2016 8:15:10 GMT -5
Is it too much to ask for a CEO of a publicly traded company to deliver what they said they would? They claimed they will be more transparent with MMannkind two point 0. Can anyone honestly say they've been transparent with anything? He made so many promises and up until now has proven to be a major failure. You can only play the "nice guy" role for so long. I'm actually surprised longs aren't coming down on him much harder. I am impressed with all the Matt bashing. Where was it when Al was at the helm? His decisions sunk the company and Matt is trying to get the ship off the bottom. Is it too much to ask a CEO to deliver what they said they would? No. So, why didn't people demand to know why Al didn't file for EU approval after US approval like he said they would? |
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Post by agedhippie on Oct 26, 2016 8:43:47 GMT -5
Is it too much to ask for a CEO of a publicly traded company to deliver what they said they would? They claimed they will be more transparent with MMannkind two point 0. Can anyone honestly say they've been transparent with anything? He made so many promises and up until now has proven to be a major failure. You can only play the "nice guy" role for so long. I'm actually surprised longs aren't coming down on him much harder. I am impressed with all the Matt bashing. Where was it when Al was at the helm? His decisions sunk the company and Matt is trying to get the ship off the bottom. Is it too much to ask a CEO to deliver what they said they would? No. So, why didn't people demand to know why Al didn't file for EU approval after US approval like he said they would? Likely because Europe was never going to be anywhere near as profitable as the US and with limited resources the US as the home market was the place to start. The filings were renewed in the EU at the end of last year so they can start the process any time they want but it's money and distraction so now is not the time. |
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Post by peppy on Oct 26, 2016 8:46:12 GMT -5
aged and or all, isn't the fee for the EU to look at accepting afrezza something like a quarter million US dollars?
If you want to play, you have to pay. |
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Post by agedhippie on Oct 26, 2016 8:52:40 GMT -5
aged and or all, isn't the fee for the EU to look at accepting afrezza something like a quarter million US dollars?
If you want to play, you have to pay. I'm not sure. There is also the downstream problem that once it is approved you have to get it adopted by each of the national health systems or you have a drug that can be sold but no customer. |
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Post by compound26 on Oct 26, 2016 9:00:48 GMT -5
aged and or all, isn't the fee for the EU to look at accepting afrezza something like a quarter million US dollars?
If you want to play, you have to pay. I'm not sure. There is also the downstream problem that once it is approved you have to get it adopted by each of the national health systems or you have a drug that can be sold but no customer. agree. For anything like a filing with EU for a new drug approval, it is far more than paying the filing fee and submit the application, I would imagine you will need a team of dedicated people to prepare the filing to the best you can and coordinate with the approval authority (EU central and then on a national level, as necessary) on many issues. Plus, more than likely, Mannkind will need additional clinical trials to support the filing. Even for the filing itself, if Mannkind decides to file, the filing must be vetted by the leadership team (Matt, Mike and Ray), technical and legal team many rounds to make sure they feel they got everything covered. So it likely is pretty time-consuming process. Right now, leaving aside the financial resources, I think everyone at Mannkind is tapped out. With the very tight financial resource, I think Matt is probably 100% focused on getting additional financing right now, while Mike is doing whatever he can to forge ahead on Afrezza re-launch and Ray on Epi-inhaler formulation and trial. So right now, Mannkind simply can not handle a separate new filing to EU, whether by its own choice or otherwise. peppy so an EU filing is probably not that simple as paying the filing fee and submit the filing. It is not like that Mannkind has already got the filing prepared and supporting data ready. I recall Matt talked about EU filing in a recent presentation. Do not remember the exact words, but my impression is that he basically said Mannkind hasn't looked the details about EU filing recently, but most likely to file in EU additional clinical trial will be needed. I also have the impression of that if they do file for a new application, they maybe thinking about getting the pediatric market approved first. |
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Post by rockstarrick on Oct 26, 2016 9:29:53 GMT -5
Is it too much to ask for a CEO of a publicly traded company to deliver what they said they would? They claimed they will be more transparent with MMannkind two point 0. Can anyone honestly say they've been transparent with anything? He made so many promises and up until now has proven to be a major failure. You can only play the "nice guy" role for so long. I'm actually surprised longs aren't coming down on him much harder. "If I was Matt", after reading or hearing all of the insults before and after our conference calls for the last few years, I just wouldn't say anything, (I'm not CEO material, FYI). I have read these insults, pages and pages of Matt bashing, by several different investors, on several different social media forums. Im just pointing out that Matt is dammed if does, and dammed if he doesn't, there is no argument here, this is a completely true statement. I don't blame Matt for not speaking because of this. I don't think there is a mnkd investor, long or short, who isn't just dying to know what the hell happened over the last few years, I know I am. |
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Post by lennymnkd on Oct 26, 2016 9:42:11 GMT -5
Great summary .
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Post by bwills on Oct 26, 2016 10:21:53 GMT -5
Is it too much to ask for a CEO of a publicly traded company to deliver what they said they would? They claimed they will be more transparent with MMannkind two point 0. Can anyone honestly say they've been transparent with anything? He made so many promises and up until now has proven to be a major failure. You can only play the "nice guy" role for so long. I'm actually surprised longs aren't coming down on him much harder. "If I was Matt", after reading or hearing all of the insults before and after our conference calls for the last few years, I just wouldn't say anything, (I'm not CEO material, FYI). I have read these insults, pages and pages of Matt bashing, by several different investors, on several different social media forums. Im just pointing out that Matt is dammed if does, and dammed if he doesn't, there is no argument here, this is a completely true statement. I don't blame Matt for not speaking because of this. I don't think there is a mnkd investor, long or short, who isn't just dying to know what the hell happened over the last few years, I know I am. The old saying is, "if you can't stand the heat, then you should get out of the kitchen." |
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Post by MnkdWASmyRtrmntPlan on Oct 26, 2016 10:28:10 GMT -5
Getting back to bthomas55ep's original post in this thread ... does anyone know of any status on the Label Change?
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Post by bwills on Oct 26, 2016 10:42:29 GMT -5
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