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Post by cfield23 on Oct 5, 2015 16:37:50 GMT -5
Perhaps some missed the discussion a few weeks ago about whether switch in Hakan's message regarding the pain management drug. Last year, mgt stated they had their API selected. Now, suddenly, MannKind is evaluating the "optimal" API. Some of us interpret this to mean a BP I may be negotiating with MannKind to use a branded API rather than a generic in order to protect that BP's market share. One example is GSK's Imitrix, which is a sumatriptan for migraine relief. The generic sumatriptan is manufactured by Sun Pharma, where our new CMO used to work. Is it possible that GSK's sumatriptan will become the "optimal" API for migraine pain relief...for the right price, of course? Negotiations could be the reason for the news blackout. Lack of steady news sucks for investors, but MannKind's silence does not necessarily indicate trouble. 100000000000000000% agree. To be honest, those who moan for the constant news aren't convinced in their holdings. If a company can produce a drug as effective as Afrezza, I have no reason to believe that they'll be inadequate when it comes to other drugs. I'm content to wait out the ride for the best return in the long run. I agree there's something there as far as the change in tone & the link to Sun Pharma. Only time will tell!
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Post by harrys on Oct 5, 2015 16:42:03 GMT -5
Perhaps some missed the discussion a few weeks ago about whether switch in Hakan's message regarding the pain management drug. Last year, mgt stated they had their API selected. Now, suddenly, MannKind is evaluating the "optimal" API. Some of us interpret this to mean a BP I may be negotiating with MannKind to use a branded API rather than a generic in order to protect that BP's market share. One example is GSK's Imitrix, which is a sumatriptan for migraine relief. The generic sumatriptan is manufactured by Sun Pharma, where our new CMO used to work. Is it possible that GSK's sumatriptan will become the "optimal" API for migraine pain relief...for the right price, of course? Negotiations could be the reason for the news blackout. Lack of steady news sucks for investors, but MannKind's silence does not necessarily indicate trouble. 100000000000000000% agree. To be honest, those who moan for the constant news aren't convinced in their holdings. If a company can produce a drug as effective as Afrezza, I have no reason to believe that they'll be inadequate when it comes to other drugs. I'm content to wait out the ride for the best return in the long run. I agree there's something there as far as the change in tone & the link to Sun Pharma. Only time will tell! I definitely want to believe this theory but I don't think BP will give Technosphere a chance until Afrezza proves successful. I believe this is why MNKD is more likely to develop the first few applications themselves with generic compounds.
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Post by obamayoumama on Oct 5, 2015 16:43:30 GMT -5
@cfield - thanks for capturing the specifics of what I mentioned. Too bad some people complain that management is not forthcoming yet the information is available if they took the time to look or listen. No problem. You gotta know what you own and why you own it! (not you, as I know you're long) I don't get the management bashing either. They've gotten burned (Shkreli) by being too forthcoming, so they're caught between a rock and a hard place. Seriously, I believe that if you do what Al says (take care of the patient first), the pps will indeed follow suit. I would expect Matt to clear up the note issue and also give his normal presentation but they are in a blackout, given the Qtr just ended so I wouldn't expect more than that.
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Post by cfield23 on Oct 5, 2015 17:08:27 GMT -5
100000000000000000% agree. To be honest, those who moan for the constant news aren't convinced in their holdings. If a company can produce a drug as effective as Afrezza, I have no reason to believe that they'll be inadequate when it comes to other drugs. I'm content to wait out the ride for the best return in the long run. I agree there's something there as far as the change in tone & the link to Sun Pharma. Only time will tell! I definitely want to believe this theory but I don't think BP will give Technosphere a chance until Afrezza proves successful. I believe this is why MNKD is more likely to develop the first few applications themselves with generic compounds. But do you think the reason BP wouldn't give it a chance is because of the inhalation -- and thus you think the inhalation is the reason Afrezza is not yet successful in their eyes? I think they'd view the delivery system by itself and Afrezza by itself. I think the reason Afrezza hasn't proven to be a blockbuster yet is merely because of the black box warning and the restrictions for advertising. I don't think it's because it's inhaled.
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Post by Deleted on Oct 5, 2015 17:18:03 GMT -5
I definitely want to believe this theory but I don't think BP will give Technosphere a chance until Afrezza proves successful. I believe this is why MNKD is more likely to develop the first few applications themselves with generic compounds. But do you think the reason BP wouldn't give it a chance is because of the inhalation -- and thus you think the inhalation is the reason Afrezza is not yet successful in their eyes? I think they'd view the delivery system by itself and Afrezza by itself. I think the reason Afrezza hasn't proven to be a blockbuster yet is merely because of the black box warning and the restrictions for advertising. I don't think it's because it's inhaled. The reason Afrezza is not being prescribed currently as the first choice in diabetes treatment is because (1) physicians are too busy and lazy to to follow the latest developments and new products and (2) insurance coverage. These issues will be resolved in a year or two. If you are expecting blockbuster status before then I suggest selling and moving on.
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Post by biotec on Oct 5, 2015 17:29:53 GMT -5
But do you think the reason BP wouldn't give it a chance is because of the inhalation -- and thus you think the inhalation is the reason Afrezza is not yet successful in their eyes? I think they'd view the delivery system by itself and Afrezza by itself. I think the reason Afrezza hasn't proven to be a blockbuster yet is merely because of the black box warning and the restrictions for advertising. I don't think it's because it's inhaled. The reason Afrezza is not being prescribed currently as the first choice in diabetes treatment is because (1) physicians are too busy and lazy to to follow the latest developments and new products and (2) insurance coverage. These issues will be resolved in a year or two. If you are expecting blockbuster status before then I suggest selling and moving on. I believe we get the insurance worked out far before a years time.
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Post by harrys on Oct 5, 2015 17:31:48 GMT -5
I definitely want to believe this theory but I don't think BP will give Technosphere a chance until Afrezza proves successful. I believe this is why MNKD is more likely to develop the first few applications themselves with generic compounds. But do you think the reason BP wouldn't give it a chance is because of the inhalation -- and thus you think the inhalation is the reason Afrezza is not yet successful in their eyes? I think they'd view the delivery system by itself and Afrezza by itself. I think the reason Afrezza hasn't proven to be a blockbuster yet is merely because of the black box warning and the restrictions for advertising. I don't think it's because it's inhaled. I'm solely speaking from the point of commercialization of Afrezza; Technosphere's proof of concept in the market place is Afrezza. You really can't seperate the two as far as outside optics are concerned. I'm not well versed enough to deal with the question of whether the black box warning given to Afrezza would also be mandated on other applications of Technosphere. I guess the inhalation could be an issue if the FDA determined (in their infinite wisdom) that it was something inherent of Technosohere, future studies may change that determination and vindicate Afrezza. Technosphere's fate is intimately tied to Afrezza. I don't know how you got "thus you think the inhalation is the reason Afrezza is not yet successful in their eyes?" from what I had said... but I hope I've made my point clear as day.
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Post by roseylv on Oct 5, 2015 18:47:08 GMT -5
Aegis Capital appears to be a fairly small firm w/ only 260 million in assets. Honestly, I don't expect much to come of this meeting but I hope i'm proved wrong of course. Let's hope they ask a few staged questions and that Pfeffer has some strong replies. fingers crossed! :--)
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Post by Deleted on Oct 5, 2015 19:13:19 GMT -5
I think Matt has to address the outstanding notes at the Aegis presentation. If not, the rumor mill gets whipped up to a greater level. Good news, bad news or no news, he has to comment. Silence would be worse and since the notes were due the 30th, he may legally be obligated to address it in a given time period. Perhaps some finance accounting types can chime in.
Note that Al's wife Clause suffers from migraines. Al once stated "wouldn't it be wonderful if we had a migraine medicine that you could inhale and get pain relief in minutes" and currently, there is no quick effective migraine product and the pain as I understand it, can be incapacitating.
Biggest impediment to Afrezza's growth is insurance coverage. Remember, this is America and people believe healthcare costs should be paid by insurance companies. If I sound sarcastic, I am but it is the truth.
Some may be skeptical of inhalation but if you are diabetic and Afrezza improves your glucose control significantly and makes it easier to do so, you are likely on board. Same with migraines - if the pain is incapacitating and you inhale a new med and the pain is gone in minutes, it is life altering.
We do need to see NRx for Afrezza start to grow consistently week over week. Enough of a foundation is in place that not getting consistent modest growth at this time raises eyebrows, at least for me.
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Post by mnholdem on Oct 5, 2015 19:42:49 GMT -5
Doesn't settlement of the Notes fall under required reporting of Form 8-K Item 1.02 Termination of a Material Definitive Agreement?
If I'm correct in my interpretation of this event, the SEC rules require Matt to file this event within four business days, which would be Tuesday, October 6.
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Post by suebeeee1 on Oct 5, 2015 20:37:09 GMT -5
What is happening (or not happening) which keeps Mannkind from posting pipeline research on its webpage. Wherever you go...to which ever small pharma you choose, there is a list of pipeline projects. We have been told of the pulmonary hypertension and the pain management (maybe migraine), so why isn't it up yet? Just one on the site would help out loads I bet!
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Post by od on Oct 5, 2015 20:53:36 GMT -5
Perhaps some missed the discussion a few weeks ago about whether the recent switch in Hakan's message regarding the pain management drug could mean something is happening. Last year, mgt stated they had all their API selected for their pipeline. Now, suddenly, MannKind is evaluating an "optimal" API for pain management? Some of us interpret this to mean a BP I may be negotiating with MannKind to use a branded API rather than a generic in order to protect that BP's market share. One example is GSK's Imitrix, which is a sumatriptan for migraine relief. The generic sumatriptan is manufactured by Sun Pharma, where our new CMO used to work. MannKind also has a patent for delivery of sumatriptan using Technosphere (yeh, I've done my homework on this). Is it possible that GSK's sumatriptan may become the "optimal" API for migraine pain relief for the right deal, of course? Negotiations could be a reason for the company's news blackout. Lack of steady news sucks for investors and can result in speculation such as in this post, but it's important to understand that MannKind's silence does not necessarily indicate trouble. I am not suggesting your theory is flawed, but there are many sumatriptan manufacturers. NDCs can be found at www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm
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Post by nadathing on Oct 5, 2015 21:02:34 GMT -5
But do you think the reason BP wouldn't give it a chance is because of the inhalation -- and thus you think the inhalation is the reason Afrezza is not yet successful in their eyes? I think they'd view the delivery system by itself and Afrezza by itself. I think the reason Afrezza hasn't proven to be a blockbuster yet is merely because of the black box warning and the restrictions for advertising. I don't think it's because it's inhaled. The reason Afrezza is not being prescribed currently as the first choice in diabetes treatment is because (1) physicians are too busy and lazy to to follow the latest developments and new products and (2) insurance coverage. These issues will be resolved in a year or two. If you are expecting blockbuster status before then I suggest selling and moving on. I'm not looking for blockbuster status for years, but it is not unreasonable to think we should be at $6 or more right now. I also do not expect management to be continually issuing PR's, but they have not given a vision for how they intend to bring new TS applications to market given the fact they have no money to do it. I do not expect to see significant revenue from SNY's Afrezza sales for 2-3 years. It could be a year or more before sales ramp up in the EU. The market does not like silence and uncertainty and that defines the state of MNKD.
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Post by od on Oct 5, 2015 21:05:12 GMT -5
But do you think the reason BP wouldn't give it a chance is because of the inhalation -- and thus you think the inhalation is the reason Afrezza is not yet successful in their eyes? I think they'd view the delivery system by itself and Afrezza by itself. I think the reason Afrezza hasn't proven to be a blockbuster yet is merely because of the black box warning and the restrictions for advertising. I don't think it's because it's inhaled. The reason Afrezza is not being prescribed currently as the first choice in diabetes treatment is because (1) physicians are too busy and lazy to to follow the latest developments and new products and (2) insurance coverage. These issues will be resolved in a year or two. If you are expecting blockbuster status before then I suggest selling and moving on. Kastanes, I a curious why you dismiss posters who you do not think belong in MNKD with a version of "then I suggest selling and moving on"? While I don't always agree with your thinking you have earned my respect as we share this long and winding road.
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Post by notamnkdmillionaire on Oct 5, 2015 21:11:42 GMT -5
What is happening (or not happening) which keeps Mannkind from posting pipeline research on its webpage. Wherever you go...to which ever small pharma you choose, there is a list of pipeline projects. We have been told of the pulmonary hypertension and the pain management (maybe migraine), so why isn't it up yet? Just one on the site would help out loads I bet! It's because the company still hasn't locked down what they want to do. They have their candidates and they are testing. But keep in mind that they have been sitting on their TS tech for over a decade and yet only have one drug out. You would think that a decade would be enough time to establish a clear pipeline. Their answer is they are working on other TS candidates and that's all we know. They sold off, I mean gave away, their other non TS candidates that are collecting dust at the other companies that obtained them for a handshake and a signature. At some point, people will have to realize that management of Mannkind continue to screw their investors over big time.
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