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Post by awesomo on Oct 20, 2018 16:47:57 GMT -5
The article was factual, FDA did issue a warning letter and they did quote it properly. However, as warning letters go this was a mild rebuke for ignoring the label copy (an entirely fair point) but this was not a particularly stinging indictment of MNKD. Repeated violations of this type might elicit a stronger response, but as a first offense it is not a huge deal. The message here is that we you have a black box warning on a drug, the manufacturer cannot make it look like an entirely benign therapeutic, and that is what the social media posting did. Yeah, the article title talks about warning letter, but the bulk of it focuses on these bullet points... - Despite the over-the-line advertising, Afrezza sales remain anemic. And ethical and honest marketing going forward is yet another challenge.
- The recent United Therapeutics collaboration is a net positive, but significant appreciation in price that followed was largely unwarranted.
- MannKind faces too many challenges going forward to be considered a sound investment in any biotechnology portfolio.
You think this is factual?
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Post by peppy on Oct 20, 2018 18:09:52 GMT -5
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Post by brotherm1 on Oct 20, 2018 19:45:11 GMT -5
The article was factual, FDA did issue a warning letter and they did quote it properly. However, as warning letters go this was a mild rebuke for ignoring the label copy (an entirely fair point) but this was not a particularly stinging indictment of MNKD. Repeated violations of this type might elicit a stronger response, but as a first offense it is not a huge deal. The message here is that we you have a black box warning on a drug, the manufacturer cannot make it look like an entirely benign therapeutic, and that is what the social media posting did. Yeah, the article title talks about warning letter, but the bulk of it focuses on these bullet points... - Despite the over-the-line advertising, Afrezza sales remain anemic. And ethical and honest marketing going forward is yet another challenge.
- The recent United Therapeutics collaboration is a net positive, but significant appreciation in price that followed was largely unwarranted.
- MannKind faces too many challenges going forward to be considered a sound investment in any biotechnology portfolio.
You think this is factual?
Whomever wrote the article’s bullet points you listed - as I once heard my dad say when I was a kid - that guy doesn’t know his ass from a hole in the ground.(although I don’t know if I ever knew what exactly that meant, I know it’s not a compliment )
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Post by sportsrancho on Oct 20, 2018 20:14:47 GMT -5
Thanks Peppy. ❤️You! ..since you said that I pinned it to my profile:-)
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Post by liane on Oct 21, 2018 5:56:16 GMT -5
This all makes me think of the quote:
"It's easier to ask forgiveness than it is to get permission."
In looking it up, it's attributed to Rear Admiral Grace Murray Hopper - to any computer geeks, what an interesting lady:
I think it would hae been a hoot to know her!
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Post by Deleted on Oct 21, 2018 6:55:51 GMT -5
This all makes me think of the quote:
"It's easier to ask forgiveness than it is to get permission."
In looking it up, it's attributed to Rear Admiral Grace Murray Hopper - to any computer geeks, what an interesting lady:
Another fitting quote from Rear Admiral Hopper, 'Humans are allergic to change. They love to say, "We've always done it this way." I try to fight that.' I know she would have been an advocate for Afrezza. Too many holligans who are truly "allergic to change". Mike needs to keep on fighting those holligans and eventually win the battle. Cant wait for that day. I will celebrate by buying more MNKD tomorrow.
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Post by morfu on Oct 21, 2018 7:13:50 GMT -5
The article was factual, FDA did issue a warning letter and they did quote it properly. However, as warning letters go this was a mild rebuke for ignoring the label copy (an entirely fair point) but this was not a particularly stinging indictment of MNKD. Repeated violations of this type might elicit a stronger response, but as a first offense it is not a huge deal. The message here is that we you have a black box warning on a drug, the manufacturer cannot make it look like an entirely benign therapeutic, and that is what the social media posting did. Yeah, the article title talks about warning letter, but the bulk of it focuses on these bullet points... - Despite the over-the-line advertising, Afrezza sales remain anemic. And ethical and honest marketing going forward is yet another challenge.
- The recent United Therapeutics collaboration is a net positive, but significant appreciation in price that followed was largely unwarranted.
- MannKind faces too many challenges going forward to be considered a sound investment in any biotechnology portfolio.
You think this is factual?
Well I would say to some extend.. the sales still have room for improvement and there are still challenges. However, I disagree that the additional funding should be equivalent to 15% in the companies share price. If you are thinking of this investment not in terms of the value of its current assets, but the potential, as you should for a startup company, the questions should be something like: Can Mannkind make profit eventually and does this new collaboration provides a significant step forward? There are some optimistic calculations on this forum estimating a break even point about two years from now. If you take an approach like in that article, Mannkind is close to worthless now and "jumps" becoming a multi Billion company on that very day.
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Post by itellthefuture777 on Oct 22, 2018 9:04:39 GMT -5
The FDA issues 483 Warning letters for label and labelling issues. One is the label on the product the other is usually marketing as in Facebook, Commercials..of the three general ones I mentioned 2 of them come with a cost. If the warning was for labels..those must be relabeled...but..it isn't that one...the other is commercials...pulling a commercial and re shooting a commercial isn't cheap...it isn't that one.. The last one..is that Facebook page..the act to censor a qoute from a patient..is but a few clicks of a mouse....
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Post by sportsrancho on Oct 22, 2018 9:18:42 GMT -5
What are people talking about a quote from a patient?
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Post by itellthefuture777 on Oct 22, 2018 10:51:24 GMT -5
What are people talking about a quote from a patient? The no drama comment...was a qoute of a patient..the FDA that delayed Afrezza 3 or 4 times because they were to busy..are Johnny on the spot for a customer qoute advertisment on Facebook..but like I said..it is click..delete..solution..
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Post by sportsrancho on Oct 22, 2018 10:55:06 GMT -5
Got it. I thought it was an ad or slogan that Mannkind came up with.
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Post by ilovekauai on Oct 22, 2018 11:09:06 GMT -5
IMO, the fix is in from the FDA. Someone who really has it in for MNKD, alerted the FDA somehow to that FB post, or someone on the board of the FDA is watching MNKD, looking for any reason to attack and discredit the company. BP reach is powerful and sustainable. They aren't giving up in trying to take MNKD down. As I've stated many times, this a war we find ourselves in, and it's nowhere close to concluding in our favor. A very long struggle still lies ahead.
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Post by awesomo on Oct 22, 2018 11:14:15 GMT -5
This is not a direct customer quote. It is marketing copy from MannKind. You see this type of promotional material all over the place.
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Post by ilovekauai on Oct 22, 2018 11:23:21 GMT -5
Thank you for the sleuth work Awesomo and clarifying this.
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Post by bioexec25 on Oct 22, 2018 11:25:10 GMT -5
This all makes me think of the quote:
"It's easier to ask forgiveness than it is to get permission."
In looking it up, it's attributed to Rear Admiral Grace Murray Hopper - to any computer geeks, what an interesting lady:
I think it would hae been a hoot to know her!
Liane, she was a amazing person. Showing my age here, and the memories are a little fuzzy, but I invited her to an ACM Chapter meeting at WKU in Bowling Green my junior year (computer science major geek fest). She came in full Navy dress and spoke to a wide-eyed bunch of programmers who were programming in the language (COBOL), that was a result of her early work on converting English statements into machine language for execution (compiler theory). The rest is history on the languages that came along after. She told us stories of military Generals looking on in disbelief, who would open the back of the early computers to see if someone was hiding inside and giving the answers to the equations she entered. Of course, the moth and the first computer bug was a classic story she told as well, we laughed and laughed, the term is still used to this day. The bins to hold computer card decks for our mainframe, even back then was called a Hopper, named after her. She had a wicked sense of humor during the meeting and at 74 years old was as sharp as a tack. Our class stayed in touch for many years and often reflected on that evening. She was a mathematician and computer scientist with immense vision and technical abilities. I don't recall much about the talk, but I remember that she told the group that we were living in a time of rapid computing advances and how important it was to stay engaged and to never stop learning. How prophetic!!
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