|
Post by itellthefuture777 on Oct 22, 2018 11:50:26 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. The cost to Mannkind...click the delete button and update Facebook...
|
|
|
Post by mytakeonit on Oct 22, 2018 15:11:19 GMT -5
In reference to bioexec's post I was in college at that time and planning on being a programmer. While riffing a bunch of computer cards ... I thought ... "This is stupid! There must be a better way to gather this information." So I was faced with two possible choices ... be a chef ... or go into business/accounting. Accounting won and I became an accountant. Worked a few years as an accountant and I said ... "This is stupid! There must be a better way to gather money." That's when I became a day trader. END OF STORY ...
|
|
|
Post by helmut8056 on Oct 22, 2018 16:25:01 GMT -5
In reference to bioexec's post I was in college at that time and planning on being a programmer. While riffing a bunch of computer cards ... I thought ... "This is stupid! There must be a better way to gather this information." So I was faced with two possible choices ... be a chef ... or go into business/accounting. Accounting won and I became an accountant. Worked a few years as an accountant and I said ... "This is stupid! There must be a better way to gather money." That's when I became a day trader. END OF STORY ... I admire your story. I kind of parallel your "STORY". I graduated from Mich. State in accounting in 1956 and went with Ernst & Ernst and eventually became a cpa. In the next five years I realized "this is stupid" but because I had five children and a wife, I didn't have the gumption to sail out of my safe harbor into open sea. Shoulda coulda woulda; "End of story"
|
|
|
Post by mytakeonit on Oct 22, 2018 18:07:24 GMT -5
helmut - see my avatar? No safe harbor here either. Damn the torpedoes ... full speed ahead !!!
|
|
|
Post by sayhey24 on Oct 22, 2018 18:55:27 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. Maybe if the copy said "So I take afrezza. No Drama" instead of saying "So I take insulin" the FDA would have been OK with it.
Everyone knows insulin is dangerous and requires needles. Its a mess. If it wasn't there would be no T2 non-insulin meds today.
Then again, you are probably correct and the war goes on. At least Mike knows he is in a war and has his eyes wide open.
|
|
|
Post by mnkdfann on Oct 22, 2018 19:04:19 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. Maybe if the copy said "So I take afrezza. No Drama" instead of saying "So I take insulin" the FDA would have been OK with it. That is an interesting observation. But the actual letter makes it clear that the FDA's issue was with "Afrezza Inhalation Powder" and not insulin generally. That is, it equated 'insulin' to 'Afrezza Inhalation Powder' already.
|
|
|
Post by sayhey24 on Oct 22, 2018 19:41:27 GMT -5
I would probably sue the FDA for the earned advertising on the grounds afrezza is not old school insulin but rather a superior meal time insulin based on the PK which allows for no drama. Have the FDA prove it is not. I will predict they can not.
Since they won't give us the ultra on the label maybe the settlement will allow the word "Superior".
|
|
|
Post by brotherm1 on Oct 22, 2018 20:30:11 GMT -5
Do we have any lawyers here familiar with lawsuits against government departments/FDA? They are immune in many ways.
|
|
|
Post by itellthefuture777 on Oct 22, 2018 21:54:44 GMT -5
I would probably sue the FDA for the earned advertising on the grounds afrezza is not old school insulin but rather a superior meal time insulin based on the PK which allows for no drama. Have the FDA prove it is not. I will predict they can not. Since they won't give us the ultra on the label maybe the settlement will allow the word "Superior". Remember that zero carb study where they gave Afrezza to type 2's and they ate nothing..and there were zero hypos...the hypos in other Afrezza clinicals with type 1's there was like a 60% plus reduction of hypo risk and the basal was what they attributed those..not Afrezza..but..FDA made Mannkind put the warning on Afrezza...but maybe they should change that to when used with a basal in type 1 the risk of hypo is reduced significantly then when a basal is used with any other insulin in thee world..hmm
|
|
|
Post by agedhippie on Oct 22, 2018 22:13:45 GMT -5
I would probably sue the FDA for the earned advertising on the grounds afrezza is not old school insulin but rather a superior meal time insulin based on the PK which allows for no drama. Have the FDA prove it is not. I will predict they can not. Since they won't give us the ultra on the label maybe the settlement will allow the word "Superior". You don't need to sue the FDA, just leave the advert up and they will start the fight for you. Unlike an untitled letter a warning letter is the start of an enforcement action, it's your chance to become compliant before this ends up in court. That's a losing proposition because you will spend a small fortune on external lawyers and consultants, execs who should be working on moving the company forward are diverted instead into the action, and prospective partners will avoid you. For all of those reasons your share price will drop until this is all over. Ultimately you lose anyway because there is a black box so by definition there is a risk of drama (likewise there are risks on the label.) In my experience of fighting government agencies settlements are around how little you can concede. They don't give you rewards like letting you improve the label as in your example. You don't pick fights with your regulator unless the threat is existential which it definitely is not in this case.
|
|
|
Post by pat on Oct 23, 2018 5:59:58 GMT -5
I think the shorties reported the blog to the FDA with the BS piece they released last weekend already written.
|
|
|
Post by agedhippie on Oct 23, 2018 6:30:14 GMT -5
I think the shorties reported the blog to the FDA with the BS piece they released last weekend already written. I think you are squarely on the money with that one. Look at the date on the post and when the warning letter went out.
|
|
|
Post by harryx1 on Oct 23, 2018 8:53:10 GMT -5
|
|
|
Post by harryx1 on Oct 23, 2018 9:49:55 GMT -5
|
|
|
Post by mnkdfann on Oct 23, 2018 10:00:26 GMT -5
I think the shorties reported the blog to the FDA with the BS piece they released last weekend already written. I think you are squarely on the money with that one. Look at the date on the post and when the warning letter went out. It looks to me as though the complaint to the FDA was lodged before July 17, 2018. Because that is the date the FDA seems to indicate it last accessed the Facebook page, prior to completing the investigation and then writing the letter.
|
|