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Post by swanybuaya on Oct 14, 2017 2:12:24 GMT -5
Does this mean another approval process with FDA on ad copy? Does Mannkind finally flood the market with dtc advertising? Do they stay the course and pound the pavement with the sales team? How do they proceed with this additional funding?
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Post by avi8torslc on Oct 14, 2017 10:09:43 GMT -5
If MNKD was smart, they would let NOVO do the heavy lifting on their new drug that was also classified aa a "fast acting" insulin. The data shows Afrezza clearly faster in/out then NOVO's drug, but let the BIG guys push the "fast acting concept" and we tag along for the ride......
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Post by qwertqwert on Oct 14, 2017 10:14:16 GMT -5
If MNKD was smart, they would let NOVO do the heavy lifting on their new drug that was also classified aa a "fast acting" insulin. The data shows Afrezza clearly faster in/out then NOVO's drug, but let the BIG guys push the "fast acting concept" and we tag along for the ride...... Exactly what Nate said in his interview yesterday. Great minds think alike.
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Post by boca1girl on Oct 14, 2017 11:16:23 GMT -5
If MNKD was smart, they would let NOVO do the heavy lifting on their new drug that was also classified aa a "fast acting" insulin. The data shows Afrezza clearly faster in/out then NOVO's drug, but let the BIG guys push the "fast acting concept" and we tag along for the ride...... Yes, tag along, get added benefit from Novo, but Mnkd must have it’s own ads or that 98% still won’t know Afrezza exists.
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Post by cjm18 on Oct 14, 2017 12:59:36 GMT -5
If MNKD was smart, they would let NOVO do the heavy lifting on their new drug that was also classified aa a "fast acting" insulin. The data shows Afrezza clearly faster in/out then NOVO's drug, but let the BIG guys push the "fast acting concept" and we tag along for the ride...... Yes, tag along, get added benefit from Novo, but Mnkd must have it’s own ads or that 98% still won’t know Afrezza exists. Novo pushing the speed thesis flies in the face of any doctor or short that said speed doesn't matter. We know it matters.
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Post by peppy on Oct 14, 2017 13:04:46 GMT -5
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Post by sweedee79 on Oct 15, 2017 22:34:27 GMT -5
The problem with dtc advertising on t.v. is the cost. Ive heard one 30 sec spot costs on average about 350k
IMO tv ads would be the fastest way to make the public aware, but can we afford that?
I trust that Mike and company have this all figured out already, where we can get the most bang for our buck and reach as many people as possible.
The label change allows us to finally talk about Afrezza as it truly is and that makes all of the difference. Effective advertising pre label change was problematic. They were smart to wait.
Recent events have been huge and it's only going to get better.
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Post by nylefty on Oct 16, 2017 8:10:20 GMT -5
The problem with dtc advertising on t.v. is the cost. Ive heard one 30 sec spot costs on average about 350k IMO tv ads would be the fastest way to make the public aware, but can we afford that? I trust that Mike and company have this all figured out already, where we can get the most bang for our buck and reach as many people as possible. The label change allows us to finally talk about Afrezza as it truly is and that makes all of the difference. Effective advertising pre label change was problematic. They were smart to wait. Recent events have been huge and it's only going to get better. As I've pointed out before there's no way MannKind could effectively use 30 second spots for Afrezza. How could you possibly combine a positive message with all the warnings required by the FDA in 30 seconds? I've never seen a 30 second spot for a prescription drug that included FDA warnings.
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Post by matt on Oct 16, 2017 8:26:52 GMT -5
Mannkind can advertise what is on the label without further permission from FDA, but only what is on the label. As noted, they must also list the most serious side effects and the black box warning at least as prominently as they list the benefits which makes a DTC campaign less effective.
To the comments above, Novo did not get a new category designation either so they are unable to advertise anything other than rapid acting either, but the market is already crowded by prandial insulins with rapid acting designations. Making enough noise to make your product stand out in DTC advertising is a tough challenge. I think the best MNKD can do it to show the PK/PD data that FDA did approve and try to convince the physicians (and insurers) that the difference is clinically relevant and economically meaningful. Normally winning that argument takes a long-term follow-up study comparing the product to others on the market, and acquiring that data is neither fast nor cheap. That is why the approved PK/PD graphs are best short-term weapon in the hands of the sales force.
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Post by oldfishtowner on Oct 16, 2017 8:58:32 GMT -5
Yes, tag along, get added benefit from Novo, but Mnkd must have it’s own ads or that 98% still won’t know Afrezza exists. Novo pushing the speed thesis flies in the face of any doctor or short that said speed doesn't matter. We know it matters. The problem for Novo though is that FIASP's speed doesn't matter, because it is not fast enough. This is in contrast to Afrezza, which is fast enough to mimic the body's own insulin.
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Post by boca1girl on Oct 16, 2017 12:22:27 GMT -5
Novo pushing the speed thesis flies in the face of any doctor or short that said speed doesn't matter. We know it matters. The problem for Novo though is that FIASP's speed doesn't matter, because it is not fast enough. This is in contrast to Afrezza, which is fast enough to mimic the body's own insulin. Novo knows this. If I was Novo’s CEO, I would want to control (purchase) Afrezza. Then I would have the best and second (?) best mealtime insulin. After all, Afrezza should not be used for smokers and others with lung issues (according to the label), so those people could be “sold” Fiasp by Novo. As a shareholder, I would NOT be in favor of a similar arrangement that we had with SNY, allowing Novo the opportunity to bury Afrezza. How about a Multi-Billion dollar purchase of Afrezza ONLY, with an on going royalty payment? Technosphere and all the other API’s would still be in MNKD’s hands.
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Post by liane on Oct 16, 2017 12:36:51 GMT -5
Sorry boca1girl - too soon to give away the cow. It's not a cash cow... yet - but it will be.
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Post by end2war on Oct 16, 2017 12:50:56 GMT -5
Raising money should now set the stage for some script growth with sales reps using the new label as an improved talking point. As this occurs, the potential for partnership money from licences to drug companies operating in foreign territories will grow with the concomitant success in the US with rising US scripts due to US label change. It is hard to predict exactly when these things will occur, but so long as the users keep praising the drug's benefits, one should expect progress with this company as it picks up more doctors that want to use fast acting insulin to control A1C better. The new label improvement is a major event for MNKD since it will allow sales reps to discuss that Afrezza is the fastest acting since its action timing is now on the label. Expense on DPC should not occur until they have hit a strong script growth like 4000, not 400, per week. The effort for now should be the doctors and insurance companies, in the US, and some foreign licensing, IMO. (They also must continue to work on patient education and satisfaction and getting repeat sales, but not with expensive advertising that will drain the coffers.)
Note from Prospectus: "Our current strategy for future commercialization of Afrezza outside of the United States, subject to receipt of the necessary foreign regulatory approvals, is to seek and establish regional partnerships in foreign jurisdictions where there are appropriate commercial opportunities."
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Post by sportsrancho on Oct 16, 2017 14:14:32 GMT -5
It will be quickly apparent if the new label is working with the Endo’s. Not to us, but to Mike. JMHO, but I would not wait one moment longer to tell the people.
( It will make it easier for the patients to get their Endo’s on board. And for sure help with insurance, but the Endo’s not so sure.)
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Post by sweedee79 on Oct 16, 2017 16:54:01 GMT -5
IMO it is still going to be a challenge to get endos and general practice to change what they are doing. We are talking disruptive change here. Way different from the current standard of care.
I still say this will be patient driven to a large degree. So somehow we have to reach the public at the same time we are educating medical pros and now we can be so much more effective in our marketing.
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