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Post by mnholdem on Jan 13, 2016 9:43:50 GMT -5
mnkdmorelong -
Regarding your comment that, "Nobody expects MNKD to do all this work on their dime with an API that does not belong to them." You are absolutely correct. My remarks were intended for FDA-approved non-branded (generic) API being developed by MannKind.
Development of an API patented by another company should, of course, be developed "on their dime". I should have been more clear that I was talking about the two API of pain and pulmonary hypertension that the company recently disclosed are in the pipeline.
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Post by mnkdmorelong on Jan 13, 2016 9:49:13 GMT -5
mnkdmorelong -
Regarding your comment that, "Nobody expects MNKD to do all this work on their dime with an API that does not belong to them." You are absolutely correct. My remarks were intended for FDA-approved non-branded (generic) API being developed by MannKind.
Development of an API patented by another company should, of course, be developed "one their dime". I should have been more clear that I was talking about the two API of pain and pulmonary hypertension that the company recently disclosed are in the pipeline.
MNKD does not have the money to pursue pain and pulmonary hypertension a la TS on their own. They need a partner. If somebody brings in an API to be ported to TS, this too would be a joint development program. Deals will be different for the two sets above. But, they should have been cut last year. IMHO.
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Post by sweedee79 on Jan 13, 2016 12:40:41 GMT -5
Mnkd and Afrezza have not ran into problems because people don't want to inhale their drugs... Ive talked to many people with diabetes and not one of them has mentioned any concern about that and in fact were anxious to try it .. The problems with Afrezza are directly related to the label and FDA restrictions ... being unable to differentiate our product .. lack of public awareness ..lack of support by medical professionals..... lack of knowledge about what Afrezza is .. Sanofis failure to start superiority studies... etc etc etc...
How important is the label? Is this holding Afrezza back? Posters on this Board do not realize that the ambit of the label goes no further than the drug company. The FDA controls how the product is made, the label, and how Afrezza is marketed. The FDA has no control over the docs who can say whatever they want about Afrezza. Or prescribe it in any way they think is appropriate. The FDA has no control over the patient who acts on "off label" information he or she received from her doc or from the web. You don't see the FDA shutting down Sam Finta's web site or any other website even though the information is off label. The FDA will shut down fraudulent website; But Sam and others are just telling their story. I and many others thought that Afrezza's rapid on and rapid off feature is a killer app that diabetics would rush to get a hold of. Clearly this has not happened. Sam Finta is an early adopter. How long will it take the great diabetic masses to use Afrezza if at all. My hope is once the price is "right-sized", diabetics will give Afrezza a shot. You are wrong... I helped my dad get on Afrezza.. the docs had no clue what it was and obviously DID NOT understand the drug ... nor were they interested in changing .. Most people I talk to have never heard of Afrezza and that is because it was never properly marketed..and. you cant train doctors about Afrezza if you are restricted by the FDA on the true benefits and what you can say.. .... you can continue with your rant.. but it is obvious you have no idea what you are talking about because you have not been out there dealing with the situation in real life ...
I have seen first hand what Afrezza can do... my dad ended up going off of it because he had no doctor support and also his insurance company dropped coverage.....Most docs I talked to hadn't heard of it.. or were waiting for some other docs to prescribe it first.. Afrezza represents a change in the standard of care... a very minimal launch.. (there was no full launch) could not overcome the obstacles that Afrezza faced ......
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Post by mnkdmorelong on Jan 13, 2016 13:12:06 GMT -5
How important is the label? Is this holding Afrezza back? Posters on this Board do not realize that the ambit of the label goes no further than the drug company. The FDA controls how the product is made, the label, and how Afrezza is marketed. The FDA has no control over the docs who can say whatever they want about Afrezza. Or prescribe it in any way they think is appropriate. The FDA has no control over the patient who acts on "off label" information he or she received from her doc or from the web. You don't see the FDA shutting down Sam Finta's web site or any other website even though the information is off label. The FDA will shut down fraudulent website; But Sam and others are just telling their story. I and many others thought that Afrezza's rapid on and rapid off feature is a killer app that diabetics would rush to get a hold of. Clearly this has not happened. Sam Finta is an early adopter. How long will it take the great diabetic masses to use Afrezza if at all. My hope is once the price is "right-sized", diabetics will give Afrezza a shot. You are wrong... I helped my dad get on Afrezza.. the docs had no clue what it was and obviously DID NOT understand the drug ... nor were they interested in changing .. Most people I talk to have never heard of Afrezza and that is because it was never properly marketed..and. you cant train doctors about Afrezza if you are restricted by the FDA on the true benefits and what you can say.. .... you can continue with your rant.. but it is obvious you have no idea what you are talking about because you have not been out there dealing with the situation in real life ...
I have seen first hand what Afrezza can do... my dad ended up going off of it because he had no doctor support and also his insurance company dropped coverage.....Most docs I talked to hadn't heard of it.. or were waiting for some other docs to prescribe it first.. Afrezza represents a change in the standard of care... a very minimal launch.. (there was no full launch) could not overcome the obstacles that Afrezza faced ......
Do you know that what you have written in response to my post is totally out of synch with what I wrote. Docs train themselves by other means than just the salesperson. As a group, they read widely. Salesmen can leave articles with the docs that describe the rapid on and rapid off feature. I am glad you helped your Dad. Hope he gets back onto Afrezza.
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Post by dreamboatcruise on Jan 13, 2016 13:14:39 GMT -5
@seedee79... your dad's story is very telling. It's an important anecdotal example just as are the stories of Sam and others. It is an example of the uphill battle Afrezza faces, but also an example of why some patients discontinue use not for lack of effectiveness but lack of coverage. Hope the situation changes for him, or that he otherwise finds something that works reasonably well.
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Post by sweedee79 on Jan 13, 2016 20:25:38 GMT -5
You are wrong... I helped my dad get on Afrezza.. the docs had no clue what it was and obviously DID NOT understand the drug ... nor were they interested in changing .. Most people I talk to have never heard of Afrezza and that is because it was never properly marketed..and. you cant train doctors about Afrezza if you are restricted by the FDA on the true benefits and what you can say.. .... you can continue with your rant.. but it is obvious you have no idea what you are talking about because you have not been out there dealing with the situation in real life ...
I have seen first hand what Afrezza can do... my dad ended up going off of it because he had no doctor support and also his insurance company dropped coverage.....Most docs I talked to hadn't heard of it.. or were waiting for some other docs to prescribe it first.. Afrezza represents a change in the standard of care... a very minimal launch.. (there was no full launch) could not overcome the obstacles that Afrezza faced ......
Do you know that what you have written in response to my post is totally out of synch with what I wrote. Docs train themselves by other means than just the salesperson. As a group, they read widely. Salesmen can leave articles with the docs that describe the rapid on and rapid off feature. I am glad you helped your Dad. Hope he gets back onto Afrezza. I read what you wrote.. as well as other things you have said .. yes, Docs can prescribe off label, but how many will do so when they do not understand the drug ... Or in most cases have never heard of it .. ?? The endos treating my dad were trying to prescribe Afrezza the same as they would injectable .... not the same thing at all, so obviously there was a problem .. the dosage is different for one, even though the instruction sheet that comes with Afrezza says they are the same dose for dose due to FDA restrictions and non-inferior status ..
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Post by mnkdmorelong on Jan 13, 2016 20:33:21 GMT -5
Do you know that what you have written in response to my post is totally out of synch with what I wrote. Docs train themselves by other means than just the salesperson. As a group, they read widely. Salesmen can leave articles with the docs that describe the rapid on and rapid off feature. I am glad you helped your Dad. Hope he gets back onto Afrezza. I read what you wrote.. as well as other things you have said .. yes, Docs can prescribe off label, but how many will do so when they do not understand the drug ... or in most cases have never heard of it .. Obviously docs will not prescribe without knowing the drug. My point is that knowing the rapid on rapid off feature of Afrezza does not need to come from the sales rep. It can be from another doc or a trade journal. MNKD does not need to spend money on a superiority clinical trial when it can achieve its goals without it. It's like the Tin Man in the Wizard of Oz. "If I only had a brain!" In Afrezza's case, "if I only had a better label." The drug is only the market. Go out and hump it.
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Post by sweedee79 on Jan 13, 2016 20:42:17 GMT -5
I read what you wrote.. as well as other things you have said .. yes, Docs can prescribe off label, but how many will do so when they do not understand the drug ... or in most cases have never heard of it .. Obviously docs will not prescribe without knowing the drug. My point is that knowing the rapid on rapid off feature of Afrezza does not need to come from the sales rep. It can be from another doc or a trade journal. MNKD does not need to spend money on a superiority clinical trial when it can achieve its goals without it. It's like the Tin Man in the Wizard of Oz. "If I only had a brain!" In Afrezza's case, "if I only had a better label." The drug is only the market. Go out and hump it. I hope you are correct...
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