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Spirometry
Jan 29, 2016 16:17:32 GMT -5
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Post by boytroy88 on Jan 29, 2016 16:17:32 GMT -5
The FDA regulates the sale, manufacture, and distribution of drugs. Physicians are licensed by the state in which they practice. Technically, the FDA cannot order physicians to do, or not do, anything, which is why physicians can prescribe drugs for "off label" use at their discretion if they feel it is in the best interest of their patient. However, physicians normally pay close attention to what the FDA says because ultimately they are legally responsible for what happens to the patient. If a physician prescribes Afrezza without a spirometer test and the patient develops complications that the test would have detected, that is a malpractice case waiting to happen. Similarly, if a physician prescribes a medication for "off label" use and the patient has an adverse event, that does not look good for the physician. So the answer is that the physicians can do what they please, but they do so at their own risk. Sanofi is regulated by FDA so their salesmen cannot market in any way that reflects claims not approved by FDA, or market contrary to what is on the approved label copy. If you want to assert that this situation is not logical, I will not disagree with you! Matt. Thank you for a great answer. Not sure why my question struck a nerve? This is what a physician told me today. I think the reason some members think the way they do is because they feel that if you are following this company that you should have already did you due diligence especially if you have invested in this company already. |
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Post by charlespk on Jan 29, 2016 16:25:16 GMT -5
Patten:
I understand you are a newbie . but your question, is something that you could have googled .
The FEV -1 test was required way back when FDA approved the drug in 2014 .
this is a serious board , and most members here have been on it for years , so that is why you got a response of - seriously?
So I suggest if you want to participate in this board that you do your due diligence about Mannkind .
There is lot of information on the internet from FDA , from Mannkind , from the insert of the prescription , etc, etc.
We welcome new members , so please learn the basics , and then you can ask and contribute on this board .
Members here have put hours and money into helping a company with a breakthrough technology that has been harmed by the hedge funds, the ex-partner -SNY and multiple other factors .
If you are going to ask basic questions that are readily available , then I suggest you go to YMB .
just letting you know how must members feel about your question , nothing personal .
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Post by Deleted on Jan 29, 2016 16:54:39 GMT -5
If any of us did the right due diligence on MNKD we'd be short. I wish I was in patterns shoes who is obviously new to MNKD and not underwater 75% like I am. I'd rather not know about spirometry then be down 75%  ? |
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Spirometry
Jan 29, 2016 16:56:19 GMT -5
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Post by patten1962 on Jan 29, 2016 16:56:19 GMT -5
Patten: I understand you are a newbie . but your question, is something that you could have googled . The FEV -1 test was required way back when FDA approved the drug in 2014 . this is a serious board , and most members here have been on it for years , so that is why you got a response of - seriously? So I suggest if you want to participate in this board that you do your due diligence about Mannkind . There is lot of information on the internet from FDA , from Mannkind , from the insert of the prescription , etc, etc. We welcome new members , so please learn the basics , and then you can ask and contribute on this board . Members here have put hours and money into helping a company with a breakthrough technology that has been harmed by the hedge funds, the ex-partner -SNY and multiple other factors . If you are going to ask basic questions that are readily available , then I suggest you go to YMB . just letting you know how must members feel about your question , nothing personal . Well I work in a hospital. Today a physician was told by a Sanofi rep that this was necessary testing.. I will post the actual text that he sent to me. I am a serious investor. Just don't believe every answer is so black and white |
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Post by patten1962 on Jan 29, 2016 17:06:48 GMT -5
This was a text to me by a physician friend. So as you can see not really a crazy question. Fyi. I am 1.trying to help. 2.trying to learn!
"Talked to the sanofi diabetes rep about afrezza and he said patients love the drug. The company( sanofi) didn't really aggressively detailed it to doctors because they only allocated one rep per district. The other thing was that pts. Need to be tested by spirometry before they started. Some MD offices have the spirometer and that's easy, or they had to send them out which was not as convient. He said sanofi is supplying them until June and then MNKD is on its own. He also knew they were shopping around for another pharmaceutical company to take over. That's the word in the street and public knowledge."
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Spirometry
Jan 29, 2016 17:09:25 GMT -5
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Post by patten1962 on Jan 29, 2016 17:09:25 GMT -5
If any of us did the right due diligence on MNKD we'd be short. I wish I was in patterns shoes who is obviously new to MNKD and not underwater 75% like I am. I'd rather not know about spirometry then be down 75% ? Thank you for the support. Did not think it was such a crazy question when Dr's that use it are not sure. |
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Post by parrerob on Jan 29, 2016 17:25:58 GMT -5
If any of us did the right due diligence on MNKD we'd be short. I wish I was in patterns shoes who is obviously new to MNKD and not underwater 75% like I am. I'd rather not know about spirometry then be down 75% ? Totally agree. I believe this board, MannKind Message Board, can and must be part of any due diligence done on MNKD. Obviously not esclusive but why not this board could help people to start a DD with links, FAQ and other ? We have very experienced members here ! If the answer is always google it and make a DD why to create a professional board ? This is one of the most interesting thread today here, imo. it is sure OT but very interesting |
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Post by BlueCat on Jan 29, 2016 17:53:02 GMT -5
If any of us did the right due diligence on MNKD we'd be short. I wish I was in patterns shoes who is obviously new to MNKD and not underwater 75% like I am. I'd rather not know about spirometry then be down 75% ? Reverselo - If I had the kind of access to the type of information for the 'right' due diligence to know that e.g., Viebacher would be ousted by the board right after MNKD partnership, and SNY would then sink and ditch this, followed by a HF short interest capable of sinking stock price just prior to a previously otherwise undisclosed/unplanned TASE offering .... I certainly wouldn't be counting my pennies here in either direction. Otherwise, if I had a crystal ball, I certainly would not have hung myself (and my family's future) by buying at highest point. But neither would I ever short a company working on a humanitarian effort. Plenty of cigarette and coal companies still out there. |
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Post by slugworth008 on Jan 29, 2016 18:13:29 GMT -5
seriously? are you for real ? I know right? I can't even respond to that ...... |
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Post by od on Jan 29, 2016 18:15:25 GMT -5
patten1962 - Lung function tesing - Spirometry - in a BLACK BOX requirement. You can probably count on one hand the number of providers that will ignore the black box on a new therapeutic modality.
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Spirometry
Jan 29, 2016 20:40:38 GMT -5
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Post by patten1962 on Jan 29, 2016 20:40:38 GMT -5
patten1962 - Lung function tesing - Spirometry - in a BLACK BOX requirement. You can probably count on one hand the number of providers that will ignore the black box on a new therapeutic modality. Thank you. But the fact of the matter is Sanofi Drug Representatives are telling Dr's to do the test. I think it's important that MannKind senior management knows this so they can get the word out that it is not necessary. Without the test I think many more prescription can be sold. |
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Post by Deleted on Jan 29, 2016 20:45:52 GMT -5
patten1962 - Lung function tesing - Spirometry - in a BLACK BOX requirement. You can probably count on one hand the number of providers that will ignore the black box on a new therapeutic modality. Thank you. But the fact of the matter is Sanofi Drug Representatives are telling Dr's to do the test. I think it's important that MannKind senior management knows this so they can get the word out that it is not necessary. Without the test I think many more prescription can be sold. I would rather do the test due to this litigation country on every chance |
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Post by od on Jan 29, 2016 20:53:00 GMT -5
patten1962 - Lung function tesing - Spirometry - in a BLACK BOX requirement. You can probably count on one hand the number of providers that will ignore the black box on a new therapeutic modality. Thank you. But the fact of the matter is Sanofi Drug Representatives are telling Dr's to do the test. I think it's important that MannKind senior management knows this so they can get the word out that it is not necessary. Without the test I think many more prescription can be sold. I think what we have here is a failure to communicate. Please re-read my post carefully. Of course, providers will do the test, and they should. I thought my post was quite clear. |
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Post by dreamboatcruise on Jan 29, 2016 20:53:30 GMT -5
patten1962 - Lung function tesing - Spirometry - in a BLACK BOX requirement. You can probably count on one hand the number of providers that will ignore the black box on a new therapeutic modality. Thank you. But the fact of the matter is Sanofi Drug Representatives are telling Dr's to do the test. I think it's important that MannKind senior management knows this so they can get the word out that it is not necessary. Without the test I think many more prescription can be sold. MNKD can do no such thing. The FDA says the test should be done. MNKD would be slapped with fines if they were suggesting doctors should not do it. |
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Post by od on Jan 29, 2016 20:59:15 GMT -5
Suggestions that the black box should be ignored? Is it me, or is this thread a bit out of control.
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