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Post by Deleted on Sept 30, 2015 8:42:30 GMT -5
Thanks for taking time to put this together. Great information and welcome to the board. People screaming for TV ads now need to realize that the ROI at this point would be better by taking the cash for TV ads and burning it in a co-gen plant to make electricity. Simply too many insurance companies requiring Prior Authorization and this means lots of time for the doctor office / staff to get the paperwork, phone calls etc which all equals doctor, patient and doctor staff frustration or put another way, $1 in benefit and $5 in aggravation. In time, the Prior Authorization issue will subside and likely is already but a slow process. If we can get the Ultra-Fast designation and a claim of lower BG levels & reduced hypos, NRx count will climb like a missile but none of this happens quickly. I do believe by the end of October, we need to see week over week NRx growth on a consistent basis and would be worried if this did not happen. The growth at this point does not need to be massive but it does need to be stable / consistent. I'm not sure of the "end of October" timeline. I hope it's soon, but based on the comments made by Sanofi recently (http://quarterly.insigniam.com/leadership/how-sanofi-will-roll-out-new-products/), I believe their approach is going to be much more "grassroots" before they start advertising like crazy. So, I'm content to see a gradual script rise, and I'm not going to be worried until I see scripts gradually decline. I don't think that'll happen. My end of October is for steady stable growth in NRx. To clarify, I am not looking for some huge week over week NRx growth but something along the lines of 3-6% (back of napkin calculation). There are enough doctors who know about Afrezza and the Sanofi sales team, who just had a refresher training program now have a bit of real world sales / marketing knowledge pertaining to Afrezza so they will be more effective. The Prior Authorization barrier, while still very large, is not as big as it was 6 months ago so while the inertia is still significant, it is not as great as it was in March. As far as a full blown marketing and sales assault in the US which includes TV advertising, I could not begin to guess when this will happen. I suspect that Sanofi, in conjunction with their ad agency will have some metrics to guide them as to when the time is right for this and I suspect one of the biggest metrics will be how many lives will have Rx insurance coverage without the burden of Prior Authorization. PS - while there are about 200 Sanofi reps who are selling only Afrezza, there is a much larger group of sales people who can sell both Afrezza and Toujeo. The latter group is a bit of a flexible sales force if you will where Sanofi can adjust on the fly how much time this group dedicates to the various products in their sales bag.
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Post by engineer4life on Sept 30, 2015 8:55:20 GMT -5
cfield23,
I wish that where will be a category of "Post of The Year". Yours certainly deserves it. Thank you for writing. I've been long since 2010 and still adding when possible.
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Post by nylefty on Sept 30, 2015 9:05:38 GMT -5
cfield23, I wish that where will be a category of "Post of The Year". Yours certainly deserves it. Thank you for writing. I've been long since 2010 and still adding when possible. I agree that it was the Post of the Year. I've had similar thoughts, but not the background and expertise to lay them out so well.
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Post by cfield23 on Sept 30, 2015 9:10:12 GMT -5
I'm not sure of the "end of October" timeline. I hope it's soon, but based on the comments made by Sanofi recently (http://quarterly.insigniam.com/leadership/how-sanofi-will-roll-out-new-products/), I believe their approach is going to be much more "grassroots" before they start advertising like crazy. So, I'm content to see a gradual script rise, and I'm not going to be worried until I see scripts gradually decline. I don't think that'll happen. My end of October is for steady stable growth in NRx. To clarify, I am not looking for some huge week over week NRx growth but something along the lines of 3-6% (back of napkin calculation). There are enough doctors who know about Afrezza and the Sanofi sales team, who just had a refresher training program now have a bit of real world sales / marketing knowledge pertaining to Afrezza so they will be more effective. The Prior Authorization barrier, while still very large, is not as big as it was 6 months ago so while the inertia is still significant, it is not as great as it was in March. As far as a full blown marketing and sales assault in the US which includes TV advertising, I could not begin to guess when this will happen. I suspect that Sanofi, in conjunction with their ad agency will have some metrics to guide them as to when the time is right for this and I suspect one of the biggest metrics will be how many lives will have Rx insurance coverage without the burden of Prior Authorization. PS - while there are about 200 Sanofi reps who are selling only Afrezza, there is a much larger group of sales people who can sell both Afrezza and Toujeo. The latter group is a bit of a flexible sales force if you will where Sanofi can adjust on the fly how much time this group dedicates to the various products in their sales bag. Ahhh gotcha. Yes I think that's fair, though I'm definitely more relaxed. I think it'd be great to see that, but I wouldn't worry if not. I like to think about the countless hours it took for MNKD to choose SNY to actually market Afrezza. Think about how much detail SNY had to provide MNKD about their strategy and MNKD chose yes. Retail investors and anyone outside SNY/MNKD upper management has no real idea about specifics, nor should they. I'm just going to sit back and trust the process. Don't invest what you cannot afford to lose. While I expect to see significant gains in the future from MNKD, if I follow this principle I'm all set if it doesn't work out. I strongly believe it will, though.
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Post by cfield23 on Sept 30, 2015 9:10:37 GMT -5
cfield23, I wish that where will be a category of "Post of The Year". Yours certainly deserves it. Thank you for writing. I've been long since 2010 and still adding when possible. I agree that it was the Post of the Year. I've had similar thoughts, but not the background and expertise to lay them out so well. Wow, thank you both!!
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Post by bullshares on Sept 30, 2015 9:19:51 GMT -5
Good read! Thanks.
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Post by jefferson on Sept 30, 2015 9:23:25 GMT -5
Thank you cfield!
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Post by zieg on Sept 30, 2015 9:25:01 GMT -5
Welcome Cfield23!! Great stuff!!
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Post by bradleysbest on Sept 30, 2015 9:25:46 GMT -5
Any idea when the clamp study will be finished? How soon after the study can the label be revised/changed? Thx
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Post by peppy on Sept 30, 2015 9:33:31 GMT -5
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Post by tripoley on Sept 30, 2015 9:46:47 GMT -5
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Post by harrys on Sept 30, 2015 9:58:45 GMT -5
Great write up cfield, you should definitely take your writing somewhere where you get more exposure. We need some thought provoking positive articles written on MNKD out to the masses. Give the fudsters some substance to choke on and they might just keel over and die.
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Post by peppy on Sept 30, 2015 10:06:58 GMT -5
Scotta, here's the timing slide from 171 from the Adcom: Thank you Tripoley. The directions were: Timing of Administration Afrezza TI was to be administered immediately before or within approximately the first 20 minutes after the first mouthful of food. Attachment Deleted
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Post by compound26 on Sept 30, 2015 10:27:16 GMT -5
Advertising Failure Case Study: Exubera
One of the reasons Exubera failed was due to it's huge ($370M in ads) overhead cost. It literally put a time limit to the success because scripts HAD to increase in order to justify continual spending. Because scripts didn't increase quickly, they had to make a rather quick/abrupt decision about keeping the drug. Now it’s not quite fair to compare Afrezza and Exubera and attribute advertising as the sole reason for failure. The actual Exubera insulin was average to inferior as compared with the RAA’s available at the time. The delivery device was also the size of a new 3 pack of tennis balls! These most certainly didn’t help the success. It failed because while it was better to inhale than to inject, it was much harder to get the insulin and it was less effective. The hassles outweighed the benefits by a wide margin. Plus, Pfizer spent so much up front that they lost all possible response agility. They weren’t able to listen to the problems and fix them. They were bleeding money. Quote Source: www.wsj.com/articles/SB119284606824265824Quote Source: www.pmlive.com/pharma_news/pfizer_scraps_exubera_9168?SQ_DESIGN_NAME=2& cfield23, great post! Agree this should be post of the year. I totally agree with cfield23 that Pfizer made a mistake in being too aggressive in the marketing of Exubera. Coincidentally, the numbers I assumed in my post (quoted below) turns out to be pretty close to the USD 370 million cited in cfield23's post. Sept 21, 2015 11:42:35 GMT -5 compound26 said: Quoting: Sept 21, 2015 11:25:12 GMT -5 zieg said: Just found out from my friend who attended: Total count of reps in Vegas was just over 200. These reps only sell Afrezza. (Frankly, I thought it would be more). Assuming this is the case, I am fine with the number on the sales force (200). That means we have an average of 4 reps in a state, with a big state having 4+ and a small state having 4-. Based on this article, the 100th largest city in the US has about 200,000 people. That means for each of these largest cities, there will be at least one rep covering it. In the bigger cities, we apparently have more than one reps covering them. It appears it will take some time for each rep to visit each of the endos and PCPs he/she covers, but if there are 5 of them covering a state, it is doable. I think Sanofi is taking a slow and steady approach, that works and I think that is a prudent approach. This will ensure that Sanofi won't be pressured to see significant sales of Afrezza in a short time frame (as compared with Pfizer in the case Exubera). That will in turn give Sanofi's Afrezza team sufficient time to carry out their strategic plan step by step, without hurry or pressure. I think Pfizer was too aggressive with Exubera (i.e., they had too many people working on the sale, but did not give it enough time; with too many people on the sale, the cost of promoting it was very high to Pfizer). Per this article (of MAY 11, 2007), "Bloomberg News reports that some 2,300 Pfizer sales representatives have been promoting Exubera to more than 5,000 doctors. But Pfizer has also hired approximately 900 additional, part-time diabetes educators to explain the product to doctors and patients, and more will be added, although the company wouldn't say how many." So in total, at one point Pfizer had 3,000+ people promoting Exubera, yet within five month of this article, Pfizer abandoned Exubera. Apparently, Pfizer put in too many people, but did not give enough time. So if Sanofi has 200 rep on Afrezza now and Pfizer had 3,000+ people promoting Exubera, cost wise, just looking at the headcount cost, Pfizer was running a 10+ times that of Sanofi. The cost of Pfizer promoting Exubera (again, just looking at headcount) for 1.5 years was equivalent to Sanofi promoting Afrezza for 15+ years. Assuming a drug company runs a $100,000 (a random number picked just for illustration purpose) headcount cost for each rep, at 200 people, Sanofi runs at $20 million per year for headcount cost for Afrezza, and at 3,000+ people, Pfizer ran at $300 million per year for headcount cost with Exubera. Now I see why Pfizer did not give Exubera more time. It was too expensive for Pfizer to continue the program at that scale much longer. The more I looked at the numbers, the more I think Sanofi's approach is the more prudent approach.
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Post by cfield23 on Sept 30, 2015 10:38:35 GMT -5
compound26 I agree! I believe the $370M number I quoted refers only to advertising. The headcount included would push it much higher than that. Great points.
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