|
Post by rockstarrick on Nov 10, 2015 16:20:59 GMT -5
I have a very long investing horizon ahead of me and my stocks are all in cash so I don't have any margin calls or expiring options to keep me up at night. As for CEO of MNKD, no thank you - I have my own company to run and my own employees to worry about without the additional need to placate disgruntled share holders and disinterested analysts. I exited Wall St. because as lucrative as it was living in NYC, it was not the sort of life I wanted to live long term. I do admire Hakan and Matt's ability to weather the hail of criticism from all corners. If I were in that role, I am sure I would have told the analysts that their baseless speculation was not worthy of a reply. Are you looking for a Bass Player ??
|
|
|
Post by stevil on Nov 10, 2015 16:28:46 GMT -5
You two bashers are falling all over yourselves with adulation. Not surprised. G Patryn, as far as I can tell, you've been a long term supporter of MNKD, albeit one who points out many of its flaws. Stevil seems to be very respectful and informative while perhaps owning a short position. I don't mind shorts, we can learn from them as well. The ones that grey under my skin are the obvious FUzd spreading sort.. Keep it informative and respectful and I'll happily read everyone's position. Suebee, Truth be told, I would have been short back in August after Matt's "we're not there yet" comments. But I won't ever short this stock. I want it to succeed. I just don't see it doing so in the near future. It's gonna take a hail mary to get this company back on the right track. Hopefully it's not 4th down so we'll have a couple tries at it... But no, I am still a stock owner with no plans of selling. My shares are 60% underwater but I've got time and risk to give MNKD a chance to make things better. edit- I just won't be adding to my position until that hail mary gets completed
|
|
|
Post by kball on Nov 10, 2015 16:36:59 GMT -5
Sanofi isn't gonna excite the partnership, it's gonna buy Mannkind at a bargain price and save all the benchmark payments still outstanding. My thinking to some degree too. Buy out before approval in other countries saves them at least 50 million. ANd if they buy out before 250 million annually in sales it will save them a small fortune. Mannkind held hostage for now. As they are forced to scramble and be creative.
|
|
|
Post by blindhog1 on Nov 10, 2015 16:38:51 GMT -5
Sanofi isn't gonna excite the partnership, it's gonna buy Mannkind at a bargain price and save all the benchmark payments still outstanding. It's more probable that Sanofi buys into Mannkind at a decent percentage. When TS has a couple of deals going you might see an interesting group of companies in the action. At that point Sanofi might just consider outright ownership. It doesn't matter to me. I use Afrezza and it's not going away.
|
|
|
Post by mdcenter61 on Nov 10, 2015 16:41:03 GMT -5
That's assuming Al will agree to sell at their price though. I'm not sure Al is going to let go of this company while he's still alive. Unless he has another 5+ years.
Stevil - I have to admit that this is a factor that troubles me. Al has done so much good through his many ventures, and my feeling is that he views MNKD as his ultimate legacy and achievement. The positives are that Al will not let his legacy fail while he is alive; the negatives are that Al is 90 years old and given his financial status and his emotional and financial investment in MNKD, is he too stubborn in looking at fair offers and alternatives which deviate from his perception of MNKD's value but are legitimate offers benefitting all shareholders? Ultimately, it looks like it will depend on this next year's script growth and TS development to bring the PPS up; I don't see a BO in any form or fashion in the near future.
I've been a stockholder since 2008, through CRL's, Adcomm, approval, and launch. Own more stock now than I should, but not going anywhere, just looking at the realistic side of things. Best of luck to all fellow longs.
|
|
|
Post by cobra2112 on Nov 10, 2015 16:43:55 GMT -5
Aside from a few print ads, I have seen no other marketing for Afrezza. In my opinion, Sanofi completely botched the launch of Afrezza. This product works, and works incredibly well. The lack of insurance coverage doesn't help. What's so hard about producing a commercial to help get the word out?!?!
|
|
|
Post by stevil on Nov 10, 2015 16:47:04 GMT -5
Ya, I don't really think he's going to sell it. Think about how much he invested in Afrezza. Maybe I don't give him enough credit, but I know if I were him and believed so strongly in the product to dump as much time and money as he did into it, I don't think I could let it go for cheap... he clearly believes in TS AND Afrezza. Let's just hope it works out for all of us and we get enough time and the right partners to show off all our potential
|
|
|
Post by seanismorris on Nov 10, 2015 16:51:33 GMT -5
I don't think we'll see Sanofi consider exiting the partnership next year. But if the do, I don't think we'll have another partner step up. We'd probably be at the point of selling assets (Afrezza or licensing TS) to try to survive until the 3 other TS prospects advance.
Sanofi basically already paid for Afrezza, they'd be better of (financially, no morally) letting Afrezza and MannKind die a slow death due to lack of resources than walk away.
|
|
|
Post by spiro on Nov 10, 2015 16:57:27 GMT -5
Spiro is not in the mood to argue with anyone at the moment, but he does strongly agree with jpg about the safety trials being the critical link that will validate Sanofi's commitment. At first spiro was angered by the TASE deal, but he has now evolved his thinking to believe that this deal should keep MNKD's price somewhere around $2 for quite a while. This will be troubling for the shorts to accept. Spiro does not not believe the shorts will sit around and watch Sanofi and MNKD move forward with their marketing strategies, while they are paying $1.20 or higher in interest to borrow over the next 12 month's. While Spiro has not been pleased with MNKD's management, several statements made during yesterday are are actually true. The most important one being the positive feedback regarding Afrezza from patients and doctors. The following events could easily accelerate the shorts exit from MNKD.
A. Increased Rx numbers B. News of Superiority trials being developed ( this could be coming soon ) C. UK and European applications for Afrezza D. Long term safety studies E. If Sanofi starts the safety trials, they will buy MNKD shares, go to the bank with that news. F. Technosphere pain licensing deal G. Other Technosphere deals ( don't hold your breathe here H. Leadership change, Hakan a nice guy, but MNKD needs better communicator I. Significantly expanded insurance coverage J. Significantly expanded DTC with TV coverage K. Other?
Capitan Spiro here, he will win here, or go down with the ship
|
|
|
Post by cathode on Nov 10, 2015 16:59:39 GMT -5
Aside from a few print ads, I have seen no other marketing for Afrezza. In my opinion, Sanofi completely botched the launch of Afrezza. This product works, and works incredibly well. The lack of insurance coverage doesn't help. What's so hard about producing a commercial to help get the word out?!?! This has been discussed ad nauseum. Commercials are highly non-targeted and costly, though they have the potential to reach a large number of people. If Sanofi advertised widely to the populace early on, patients might bring expectations of getting a prescription to their doctors only to be met with tremendously high prescription costs and other roadblocks that could turn them off of the product down the road, even when these issues are potentially resolved. If you do your research on any of the conferences or calls from this year, you would consistently hear about the strategy that is being employed. Regarding the efficacy of the product, again I would suggest you recall that both MNKD and SNY are very limited by the FDA in what they can say about the product. This limitation extends to public and private communications (sales reps to doctors, for instance).
|
|
|
Post by babaoriley on Nov 10, 2015 17:17:20 GMT -5
Spiro is not in the mood to argue with anyone at the moment, but he does strongly agree with jpg about the safety trials being the critical link that will validate Sanofi's commitment. At first spiro was angered by the TASE deal, but he has now evolved his thinking to believe that this deal should keep MNKD's price somewhere around $2 for quite a while. This will be troubling for the shorts to accept. Spiro does not not believe the shorts will sit around and watch Sanofi and MNKD move forward with their marketing strategies, while they are paying $1.20 or higher in interest to borrow over the next 12 month's. While Spiro has not been pleased with MNKD's management, several statements made during yesterday are are actually true. The most important one being the positive feedback regarding Afrezza from patients and doctors. The following events could easily accelerate the shorts exit from MNKD. A. Increased Rx numbers B. News of Superiority trials being developed ( this could be coming soon ) C. UK and European applications for Afrezza D. Long term safety studies E. If Sanofi starts the safety trials, they will buy MNKD shares, go to the bank with that news. F. Technosphere pain licensing deal G. Other Technosphere deals ( don't hold your breathe here H. Leadership change, Hakan a nice guy, but MNKD needs better communicator I. Significantly expanded insurance coverage J. Significantly expanded DTC with TV coverage K. Other? Capitan Spiro here, he will win here, or go down with the ship Love your enthusiasm, Spiro. Have to hand you that, and also admire the cat-like rebalancing you did after initially saying how upset you'd be with dilution being a part of the Israeli deal. I don't mind the deal yet, but I will not be happy at all if it goes down for under two bucks! And for those who do not know Spiro well, he can rattle of the above points in rapid succession verbally, the man is as sharp as a tack.
|
|
|
Post by yossarian on Nov 10, 2015 17:19:03 GMT -5
It's a question of time for Technosphere. Clinical trials will take years. Mannkind may not have that kind of time.
|
|
|
Post by jpg on Nov 10, 2015 17:23:39 GMT -5
I've been following Sanofi studies with a great deal of interest (as I keep on posting about to often limited interest!). That yet to be started 8000 patient study that analysts (and yes even now AF...) picked up on yesterday could be a money pit if done randomized and comparatively to standard of care. This study could show beyond any doubt that Afrezza is superior to standard of care if set up right.
Sanofi is setting up a 500 (not 5000 and certainly not 8000) patient study looking at PCSK9 modulation in diabetics (and using Afrezza as a prandial insulin): NCT02585778. This PCSK9 study is good but the real deal will be the 8000 patient study which (from what I can tell) is to be a true randomized 5 year trial (and not simply a case controlled follow up of patients on Afrezza). I may be wrong on this though (and the difference in $ price is huge). The status seems to still be in negotiations with the FDA right now so who knows how (and if) this will be done.
Some other studies Sanofi is or will be recruiting for Toujeo:
A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM): NCT02451137
Comparison of MyStar DoseCoach to Routine Titration in Adult Patients With Type 2 Diabetes Mellitus Using Toujeo (AUTOMATIX)
Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Type 2 Diabetes Mellitus Patients (TITRATION)
For Lixisenatide: Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine
Look at how many patients in these trials compared to the #s for Afrezza trials so far. Do you think Sanofi will start a randomized control trial in 8000 patient trial for Afrezza? Really? Could this not be why January 1st was used as a cut off date for 'notice'? After seeing that Safofi investor conference I have my doubts. I think that with this requirement the FDA hurt us as much as bad financing decisions by Mannkind.
As a side note this is the type of trial that I would have hoped Afrezza to be involved in:
Efficacy Study of Liraglutide vs.Sitagliptin vs. Glargine on Liver Fat in T2DM Subjects (LIGHT-ON): NCT02147925
Very cool. Not industry sponsored and it will possibly answer some very exiting questions (that I think Afrezza would have been well placed to participate in).
To those who think I am bashing I am simply stating what I now believe and have invested accordingly.
|
|
|
Post by mindovermatter on Nov 10, 2015 17:30:48 GMT -5
I've been following Sanofi studies with a great deal of interest (as I keep on posting about to often limited interest!). That yet to be started 8000 patient study that analysts (and yes even now AF...) picked up on yesterday could be a money pit if done randomized and comparatively to standard of care. This study could show beyond any doubt that Afrezza is superior to standard of care if set up right. Sanofi is setting up a 500 (not 5000 and certainly not 8000) patient study looking at PCSK9 modulation in diabetics (and using Afrezza as a prandial insulin): NCT02585778. This PCSK9 study is good but the real deal will be the 8000 patient study which (from what I can tell) is to be a true randomized 5 year trial (and not simply a case controlled follow up of patients on Afrezza. I may be wrong on this though (and the difference in $ price is huge). The status seems to still be in negotiations with the FDA right now so who knows how (and if) this will be done. Some other studies Sanofi is or will be recruiting for Toujeo: A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM): NCT02451137 Comparison of MyStar DoseCoach to Routine Titration in Adult Patients With Type 2 Diabetes Mellitus Using Toujeo (AUTOMATIX) Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Type 2 Diabetes Mellitus Patients (TITRATION) For Lixisenatide: Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine Look at how many patients in these trials compared to the #s for Afrezza trials so far. Do you think Sanofi will start a randomized control trial in 8000 patient trial for Afrezza? Really? Could this not be why January 1st was used as a cut off date for 'notice'? After seeing that Safofi investor conference I have my doubts. I think that with this requirement the FDA hurt us as much as bad financing decisions by Mannkind. As a side note this is the type of trial that I would have hoped Afrezza to be involved in: Efficacy Study of Liraglutide vs.Sitagliptin vs. Glargine on Liver Fat in T2DM Subjects (LIGHT-ON): NCT02147925 Very cool. Not industry sponsored and it will possibly answer some very exiting questions (that I think Afrezza would have been well placed to participate in). To those who think I am bashing I am simply stating what I now believe and I now am invested in Mannkind accordingly. In the past, has Sanofi had to do such a long term trial with as many patients as is being requested for Afrezza? And is it possible that the negotiations with the FDA for this 5 year trial might include a reduction in the number of participants?
|
|
|
Post by jpg on Nov 10, 2015 17:49:22 GMT -5
In the past, has Sanofi had to do such a long term trial with as many patients as is being requested for Afrezza? And is it possible that the negotiations with the FDA for this 5 year trial might include a reduction in the number of participants? This is a new FDA. This 'new FDA' is different from the one before (which lasted about 2-3 years) and the one before (6-8 years?). This may sound sarcastic (and it is) but the FDA represents the public interest with a huge amount of political interference from different lobby groups so 'standard operating procedures' are flexible. This being said it is (to me anyway) the most respectable drug approval body in the world 'over the long term'. I say all this because this 'new FDA' is now tired of drugs that get to market and have 'unforeseen' side effects creep up when more patients use them. I do think the FDA is moving in the right direction with this type of work though. I strongly believe that big phase 4s are the future (but aren't cheap). Sadly for Mannkind this focus is particularly hard on diabetes (and why I think SGLT2's will get taken down by pathological fractures but that is another story...) and to coincide with this insurance companies are consolidating and want to kick pharma on pricing (Turing and Valiant pharma although unrelated to patented medication isn't helping!). Many of the prandial insulins are soon coming off patent and interestingly most BP dealing with diabetes are rushing to build away from insulin? Interesting coincidence no? We know medically insulin is the way to go but we are mostly moving in the other direction? It is also 'interesting' to see Sanofi make so many recent diabetes deals that follow almost step for step what it's competitors are doing. New CEO and dramatically new diabetes focus. No more risky science based moves it seems. Al, this to say I don't have a good answer (or any answer to your question!) other than to say much of this is played on a level where Afrezza is barely even an afterthought...
|
|