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Even if not, still very nice to watch! Mahalo for sharing Jack.
Always nice to see Green on 3 consecutive days for sure.
Aloha Crew: Just stop and think for a moment how far MNKD has come these past 18 months. It's remarkable! From FDA trials, approval, securing a powerful international pharmaceutical company, (Sanofi), as our global partner, and product on the shelf across the USA! (with EU approval coming up next!). For goodness sake, just think about all that! It's incredible what Dr. Al Mann has achieved these past months. I ride with him; anywhere, anyplace! Go MNKD/Afrezza/Sanofi/Google!
Trust me Conix, the shorts are already nervous and have been for awhile. Rising, weekly script count has them on edge. Maybe that Sanofi rep meeting in Vegas a month ago, where Afrezza sales training happened, is starting to pay dividends. Aloha.
Aloha Etpa: Excellent article on potential Tier 2 coverage, and how Afrezza is a superior product. Only a matter of time isn't it!! Mahalo for sharing!
Aloha Crew: IMO, Sanofi had a lot of catching up to do in order to launch Afrezza the right way.
The biggest item being ignored about Sanofi's launch strategy is the fact they have only been working with Afrezza for a little over one year, because of Mannkind's decision to wait for FDA approval to sign up a commercial partner.
Most pharmaceutical company's have the luxury of launching drugs they have developed internally themselves for many years, or have a licensed or partnered drug from another company since mid to late stage development for several years. Unfortunately Sanofi has had virtually no time to prepare or execute a pre-launch strategy for Afrezza, and that's what they've been doing for their Phase I controlled launch of Afrezza from Feb - Sept 2015.
Also the label Mannkind handed over to Sanofi was not ideal. Mannkind was hoping to get Afrezza approved as a first-in-class Ultra-Rapid Actin Insulin and instead the FDA delivered a restrictive label for Afrezza as just another "me to" rapid acting insulin offering delivery convenience, which the FDA also side tracked by requiring spirometry testing. Let's hear it for the FDA! Right?
So bottom line when the licensing deal became official in September 2014, Sanofi had to quickly get a global organization in place to begin working on Afrezza and get it ready for a launch in the United States. It took Sanofi only 4 months from Sept. 2014, to launch Afrezza in the U.S. in Feb. 2015, that ended up being more like a pre-launch to allow Sanofi time to gather real world experience for Afrezza with; early adopters, healthcare professionals and work on getting improved insurance coverage, improved manufacturing capacity including 12U and clinical trials to improve the label. Well, all that work is now done and Sanfoi has now initiated a Phase II full launch for Afrezza in the U.S. and is getting ready to roll out Afrezza outside the U.S. Cheers!
Mahalo RF2. IMO the video is done really well. I give it a thumb's up! Aloha.
Can't argue with that BI. Mahalo for sharing. Aloha.
Honor and Courage
My fellow Longs; you display honor and courage, holding this stock despite a constant barrage of FUD by shorts. I salute you. Your DD is on point. Afrezza and Technosphere are the real deal. Our day will come and it will be beautiful. Aloha.
Aloha Crew: Check out this new video on how awesome Afrezza works. Very well done! Onward and upward Longs! https://www.afrezzapro.com/how-afrezza-works
Yes Robert, I noticed that as well. It's great to witness the steady rise in script counts these past weeks. Slowly but surely for Sanofi has always been the mantra for me! Aloha.
I'm with you Hawk. I've been through several r/s the past years and each and every time it's been a total disaster. I say run for the hills if this talk of a r/s gets legs. Not trying to stir up any trouble here, just expressing my opinion. Aloha.
Each week the script count tends to go up a little bit. Just steady, slooooooow growth and small numbers. Mannkind has been beat to death in the media and by analysts about the slow start of Afrezza. However, I want to point out that todays number is better than the script number two months ago. I bet the script number two months from now will be better than today.
There's a point coming when the latest steady script number will be 1000 and then 2000 and so on. There is a tipping point coming that will then cause the script count to cut the other way. That steady slow growth will become the rally cry for why Afrezza and Mannkind is the investment to own. I "patiently" look forward to the day when I hear an analyst say that Mannkind is a strong buy because of the steady growth of Afrezza. Sanofi is NOT going anywhere Crew. They know what they have in Afrezza...a winner! Aloha.
Excellent article on Tier 2 coverage, just published on Seeking Alpha, by Robert Sacher.
Mahalo Robert for writing such a great article! http://seekingalpha.com/article/3575996-sanofis-challenge-unrestricted-insurance-coverage-for-mannkinds-afrezza?auth_param=9br4d:1b204n1:8e15885b64e2b267b78ca4262a762126&uprof=51
Sanofi November 6, 2015 "Meet Sanofi Management" Conference Call
The call will start @ 8:30 AM CET In France and 2:30 AM EST In New York
MEET SANOFI MANAGEMENT
November 06, 2015
Sanofi will organize a Meet Management Seminar
at its Headquarters in Paris on November 6, 2015.
A live webcast of the plenary session will be available
from 8:30 to 10:00 am CET.
Senior management representatives will provide a business update and outline a roadmap towards 2020. We will also present the latest progress of our R&D pipeline. http://en.sanofi.com/investors/events/corporate/2015/2015-11-06_IR_Seminar_Meet_Management.aspx
Nice find, nice read and we Longs will prevail. Aloha
Aloha Crew: Things are progressing forward with MNKD. Shorts still bashing all day...means nothing to me. The science and Team is solid. I can still buy/sell, so it's not the end of the world. I see things coming together, but it isn't an overnight thing. IMO, looking to 2016 and beyond. As for now, just storing up! Such nice buying opportunities!
Sweet! Fundstrat is recommending some buying and check out who made the list! Aloha. http://finance.yahoo.com/news/14-healthcare-stocks-fundstrat-buying-153945301.html
Liking your post RF2! Aloha.
You know it did Phaeton! Notice how that topic suddenly disappeared from the Shorts attack list? And, what of AF's hit piece from last week on this topic? Just another FUD "article" that's gone with the wind. That's all AF can write about; his wandering ramblings mean nothing, never did, IMO. Aloha.
Aloha Phaeton: Our time will come. I've stated about all I can here. Afrezza; just gotta wait things out. Not fun, but necessary till Tier 2 kicks-in/label change(s) too.
For sure an island luau for all, but that could be a ways off yet! I remain Long.
Sanofi's Point of View
1. They know they have a very effective drug in Afrezza, but its immediate success is not financially important to Sanofi.
2. They want to negotiate the highest price possible to achieve tier II coverage and they are in no hurry to lower the price when they can wait for superior medical results to add leverage against the insurance companies.
3. Large scale advertising without full tier II coverage only creates a situation where patients are unable to get Afrezza, because they can't afford it yet under their current coverage.
4. Shorts will cover in direct proportion to insurance tier II coverage including the time delay built into the advertising / sales / prescribing process.
Both the longs and the shorts are correct. The shorts are correct that Mannkind's profitability is many months aways. The longs are correct that Afrezza will eventually have significant worldwide marketshare.
Looking forward to your article Robert. I always reading your articles. Aloha.
Btw Crew; the debt issue was quietly resolved, no dilution, no nothing. This was a short's talking point. They paid 1/2 in cash and the rest in stock or notes (not sure on that). But they did not feel the need to file a 4, will be in the next quarterly report. Aloha.
It could be that too. Hopefully it will be resolved soon. Aloha.
Every trading day I need to breath deep and remember, I am not trading, so today's price is of no consequence. All sound logic points to a superior product that will be in very high demand. Yes, there is no such thing as easy money. This is the stage where longs earn it. For those who have been on this train for 10+ years, I tip my bonnet. This is not easy money.
Longs hold four aces; do not fold now. Aloha.
A good opinion to be sure Kevin. It's incredible what has happened at YMB. Aloha.
Robert M. Califf is Obama's nominee to serve as head of the FDA. He is such an insider with BP, and I find the nomination disquieting
Afrezza is a disruptive new insulin; fighting for market share against BP. This person is beholden to BP IMO.
Here's a little background on the nominee:
A recent exposé by the New York Times revealed that Califf's multi-million dollar research center at Duke received more than 60 percent of its funding from the industry, while his 2014 financial disclosure documents showed drug companies like Eli Lilly, Merck, and Novartis paid him hefty fees for "consulting" and in salary support. And as the Boston Globe reported on Wednesday, Califf also took the "highly unusual" step of removing his name from a series of scientific papers criticizing the FDA's oversight of clinical trials—"a decision that could raise ethical concerns," explains the Globe's Sheila Kaplan.
Aloha.
Agree. Tier 2coverage will open the flood gates. It will happen. Aloha.
Ha-ha, love the soup du jour analogy! Aloha.
I felt the same. Things are moving along as expected. Debt was dealt with too. Aloha.
Holding strong right around .15 Decent volume today too. Aloha.
I'm not going anywhere regardless of what transpires tomorrow. IMO we need Tier 2 before this bad girl really gets moving.
Being more forthcoming is always nice, especially if there's something newsworthy to talk about, and many here want to see that. Perhaps we'll learn more tomorrow. Aloha.
With profits from MNKD, we can buy Bubba's! Aloha.
Anphastar Presentation Sept 2015
Recombinant Human Insulin (RHI)
- Signed supply agreement with MannKind to supply RHI for Afrezza®
- Agreement specifies minimum annual sales of 24 million euros annually for 5 years from 2015 - 2019
- Further amounts may be purchased
- Several other customers currently purchasing R&D quantities for filings outside of the US
- One customer buying production quantities outside of the US
- Signed Option Agreement to supply additional quantities in 2016-2019
- If MannKind chooses not to exercise its option, they pay a cancelation fee
IMO, Sanofi must be planning for international expansion by supplying insulin for Afrezza on top of Amphastar's insulin.
MannKind has bigger ambition for its Technosphere technology. Aloha.
Your expressive language about the detractors who post here is refreshing to say the least, and they will gone with the wind as soon as MNKD makes its inevitable climb upwards. Meantime, Kauai will always be here. My place is on the North Shore, past Hanalei, in Wainiha. The 1950 movie South Pacific was filmed here and nothing here has changed since. Great place for a MNKD celebration party IMO someday soon! Aloha.
It is a fantastic buying opportunity Goose, and I plan to hold till the end of this decade. Afrezza will be worldwide by then. Aloha.
Mahalo Kevin. Excellent work! Aloha.
Correct Cave. You know what this is all about. Always enjoy your posts. Aloha.