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Post by esstan2001 on Jan 14, 2016 17:06:36 GMT -5
stevil , I disagree...... I wouldn't piss in their ears if their brains were on fire. Just my opinion of Sanofi, I enjoy reading your professional input. Boycott Sanofi wow I spit up my water when I got to that line :-)
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Post by esstan2001 on Jan 14, 2016 10:06:20 GMT -5
Spiro, a little birdie told me that they have an (as of yet) undisclosed plan to focus sales efforts on small regional centers... and they got this idea from George Rho's article- I saw it there in print. Wasn't this your idea? We will have to make sure that Matt sends you all commissions on the sales in the Florida keys. Maybe we can send Baba down there as the 'enforcer'. I think we will have to see how much leverage Liane has with him now. But it may not take too much, he confessed to me liking sailing on small catamarans... Hobie cats I believe- I think he wants to get back into it, and start a charter operation down there near you know, Cuba... smuggling out old American car parts to keep the locals up and running. I can't even begin to picture myself on a Hobie Cat at this point! But the water down in South Florida is pretty warm, so maybe.... You could call the operation, "O'Reiley Auto Parts" (NASDAQ: ORLY)
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Post by esstan2001 on Jan 13, 2016 22:53:46 GMT -5
EXCITED to see potential TS uses in MRSA and fungal infections such as aspergillosis as in theory should be more effective given alveolar absorption in contrast to venous access. Also, in the setting of acute pain, TS Fentanyl could be a very handy tool to have in the ER for trauma patients not to mention acute pain patients on the battlefield or any patient for that matter who do not have IV access. Given many of these have potential to be used by our military, and given Al Manns history of working with the military and NASA, I do not think it would be a surprise to see Fed grant money to further research and develop some of these TS candidates. Al has been out of DoD world for too long for contacts to be relevant. A lot of those organizations have high turn over. DARPA has a policy that their program managers are only there for 4 years. The overhead of dealing with DoD is high as well. Isn't Kent Kresa (on our BoD) Chairman (or former) of Northrop Grumman or something like that? Take it for what it's worth- even Al is likely still connected, albeit weakly.
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Post by esstan2001 on Jan 13, 2016 21:19:52 GMT -5
One question that I'm interested in is how much inventory we already have. I think we have a huge amount of Afrezza warehoused, so selling in bulk overseas at lower margin for cash now when we need it might make very good financial sense. There is one minor hurdle; may not even be the case if they go overseas with the insulin- that is it is not FDA approved, but it is maintained and tested and as of last June still considered a viable source once FDA blessed it (certainly for USA use)
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Post by esstan2001 on Jan 13, 2016 21:10:25 GMT -5
If true, that would be a huge point in MNKD's favor when pressing for settlement dollars. All things considered I thought Matt's comments could not have been more accepting of SNYs efforts. Unless there is a smoking gun out there, how does MNKD make the case that they were 'had'? Step 1. Get extricated out of this god forsaken mess with SNY ASAP Step 2. Proceed forward in an attempt to negotiate a settlement in good faith Step 3. File if Step 2 does not complete to your satisfaction.
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Post by esstan2001 on Jan 13, 2016 21:00:30 GMT -5
Right on Liane, stay tuned on this one. one of our own is very involved in this development. Spiro here, not doing cartwheels, but feeling a little better about things. Spiro, a little birdie told me that they have an (as of yet) undisclosed plan to focus sales efforts on small regional centers... and they got this idea from George Rho's article- I saw it there in print. Wasn't this your idea? We will have to make sure that Matt sends you all commissions on the sales in the Florida keys. Maybe we can send Baba down there as the 'enforcer'. I think we will have to see how much leverage Liane has with him now. But it may not take too much, he confessed to me liking sailing on small catamarans... Hobie cats I believe- I think he wants to get back into it, and start a charter operation down there near you know, Cuba... smuggling out old American car parts to keep the locals up and running.
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Post by esstan2001 on Jan 13, 2016 20:45:22 GMT -5
I found myself wondering about the TS pain medication that was previously in the pipeline and was missing from today's presentation. Is that possibly related to the TS partnership announcement that is allegedly days away? That to me was the only logical conclusion... guess we will soon find out
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Post by esstan2001 on Jan 12, 2016 9:44:08 GMT -5
Since we are just killing time waiting for our fate to be decided I'll weigh in. Who killed Afrezza: The American people There is zero tolerance in this country for anything that is other than 100% unquestionably safe. The FDA embodies this and if you need proof turn on late night TV and watch the ads roll on asking you to sue your doctor or a drug company. Being a medical professional I was dumbfounded over the FDA's rejection and subsequently of their onerous testing requirements. In retrospect I shouldn't have been. I've seen this pattern time and time again. This process and expectation stifles innovation, punishes creativity and makes novel drugs unaffordable. Mannkind is an illustrative example of what the pharma companies go through on every drug they approve. I think I was naive that a small company could weather more than one or two setbacks. I focused and still focus on the great promise Afrezza shows, but watching the financial realities of running a embattled pharma company has been sobering experience. I hope they find a solution and Al Mann decides he would rather go down swinging. I agree with all that you say except for who killed Afrezza- the FDA does not represent the American people in reality; they represent themselves, and it is their fear of getting tagged with approving an unsafe drug that prevents them from rationally, scientifically assessing the benefit / risk ratio of any new medication. (Just like our Afrezza passion blinds us to rational assessment of Mannkind)
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Post by esstan2001 on Jan 12, 2016 9:17:28 GMT -5
Don't think that this announcement has anything to do with DeSisto's non-compete agreement and not taking the CEO job at MannKind!? Absolutely looks like this is why Insulet would push back on the Desisto appointment- this is likely not another case of inept management.
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Post by esstan2001 on Jan 12, 2016 8:56:32 GMT -5
How can FDA approve anything without testing on HUMAN. Of course, it was tested on HUMAN, it is equivalence/biosimilar (something like that) trials. The Dreamboat was not tested on humans... This was and still is against their own rules which Mnkd tried sidestepping with rheir modelization. Do not forget, (supposedly) they had full agreement on the bioequivalence path forward with the FDA (same drug and excipient, just changed delivery device being tested for dosing). Also recall the convicted FDA staff member that bought stock on positive inside FDA reports before Martin sent in his Christmas love letters. Technically you are correct; however it is reasonable to assume the path they took if they had agreement, all indications were that all was OK until Martin spoke up. What other path would a bunch of risk averse bureaucrats take once presented with their own rules. Just another unfortunate turn of events, but one among a very long string of them.
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Post by esstan2001 on Jan 11, 2016 16:46:58 GMT -5
alethea ... I for one will freely admit that I had been stating that I saw little chance of SNY dropping Afrezza. I was shockingly, horribly wrong about that, and as such I would suggest no one, especially me, ever pay any attention to my opinions again. Maybe we are all George; and we should try doing the opposite. If you are about to order Tuna on Rye, order the Chicken salad on whole wheat. After all, doing the opposite was how he ended up dating that attractive woman and getting the job working for Steinbrenner at the Yankees.
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Post by esstan2001 on Jan 7, 2016 13:41:27 GMT -5
"It is probably not appropriate to use the JV expense of $175M- this predominantly factors in Sanofi's bureaucracy and cost structure; which targets support to many different drugs, devices, etc. The true estimate is going to be somewhere in between, and my WAG is about 1/2 to 2/3 of this. Certainly not the full amount. " estan2001, Deciding which SNY expense to allocate to the Afrezza joint venture was always going to be a little tricky, but if MNKD allowed Sanofi to charge the venture 1/3 to 1/2 of costs that are attributable to its own products, I would be extremely upset. Greg, What they officially charge, and what they actually spend their time on (especially in light of the SNY attitude & plan regarding Afrezza) could certainly be 2 different things- I do not recall SNY specifically staffing only for Afrezza, any large Co. would transfer resources and you can bet they still have other responsibilities to continue to manage. But say I accept that ONLY dedicated resources were assigned- it is a behemoth of an organization with i am sure big overhead rates. Any targeted dedicated team from a small to mid sized organization will be markedly more efficient and require less resources to do the same thing. That is predominantly my point (and the dilution due to other responsibilities only adds to it).
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Post by esstan2001 on Jan 7, 2016 13:03:24 GMT -5
"There is no way that cutting ASP by over 50% will yield an increase in gross margin. I thought you had experience with business models? The purpose of this thread was to estimate breakeven point. It may be difficult and have a large error. But some people want to know. By knowing the magnitude, we have some insight into what MNKD is thinking now. Given all this, I think my estimate of $500 mln is still better than your $175 mln. Keep in mind Danbury burns $90 mln/yr regardless of how much Afrezza is sold." mnkdmorelong, I'm starting to realize this back and forth, too, is proving to be an exercise in futility. This will be my final response on this thread. 1. What do you think gross margins were on $10 million on sales? Is it even a meaningful figure? The more important point is that gross profits will increase massively when sales rise to $175 million from $10 million, even with a sharp reduction in the price. 2. I don't think it takes a lot of experience with business models to know that your starting point has to be reasonable accurate numbers to get anywhere meaningful. Your starting point was a loss of $50 million, rather than the far more accurate $175 million. The latter is close to being one of the only real numbers to work with, and you were off here by a magnitude of 250%. 3. Your starting point is so far off and then you conclude $300 million initially and within minutes move to $500 million. Given this, what insight have you added??? So, please, enough with the shots. 4. Perhaps you should rework your "business model" with $175 million and come up with another number. And just to make you happy, I'll concede right now that whatever you come up with is better than my number. Not that I am all that interested in getting into the middle of all this but: It is probably not appropriate to use the JV expense of $175M- this predominantly factors in Sanofi's bureaucracy and cost structure; which targets support to many different drugs, devices, etc. The true estimate is going to be somewhere in between, and my WAG is about 1/2 to 2/3 of this. Certainly not the full amount.
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Post by esstan2001 on Jan 7, 2016 9:30:37 GMT -5
-after the SNY investor day where they failed to mention Afrezza in any of their plans, this became the big concern. Somehow we all talked ourselves out of them bailing, preferring to believe that they were still evaluating, and refining their master plan. It was some grand master plan allright. 1. Gain control the threat. 2. Delay the threat. 3. Kill the threat. boy if I was a conspiracy theorist, besides having the Lazard and other financial short side connections, I'd say how they probably also had someone inside Greenhill making sure the contract left little power & recourse to MNKD in the event of perfect execution of the grand master plan. By teh way, anyone care to calculate the odds that so many successive epic fails could occur in a row, developing into the 'perfect storm' if you will, for a company with a fantastic product that 1 year ago seemingly had only a 1% chance of finding it's way here to this point....oh and did I mention, calculate them for the case 'without the intervention of any external nefarious forces involved'. Glad I am not a conspiracy theorist.
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Post by esstan2001 on Jan 7, 2016 8:56:05 GMT -5
Who cares about proving something to SNY? They always intended to kill MNKD and the sooner we act with that realization, the better. Undercutting and destroying their prandial insulin products and profiting from doing so would be a really nice "in-your-face" and an appropriate response for the hose-job SNY gave MNKD. Yes, SNY wanted to kill MNKD so badly, they paid, what a couple of hundred million for the privilege? The hit was agreed upon and sanctioned by the Cabal. They all have something to loose from Afrezza's success. (Shhh..don't tell anyone)
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