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Post by mbseeking on Nov 10, 2015 18:05:13 GMT -5
But MNKD has forced SNY' s hand now on the long term trial - and their long term commitment. I'm not convinced with Brandicourt at the helm that is the best outcome but SNY know they cant let Afrezza get away from them. I'm sure they'd calculated that MNKD was about to go broke and had been threatening too walk, delaying the big trial. Now they cant. And now they have to spend fresh real money , not sunk at the time of original deal , then SNY's shareholders will expect it to pay back.. So SNY may even have to get a hurry on with the insurance coverage now....
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Post by jpg on Nov 10, 2015 18:17:29 GMT -5
But MNKD has forced SNY' s hand now on the long term trial - and their long term commitment. I'm not convinced with Brandicourt at the helm that is the best outcome but SNY know they cant let Afrezza get away from them. I'm sure they'd calculated that MNKD was about to go broke and had been threatening too walk, delaying the big trial. Now they cant. And now they have to spend fresh real money , not sunk at the time of original deal , then SNY's shareholders will expect it to pay back.. So SNY may even have to get a hurry on with the insurance coverage now.... Not saying this will happen but why can't they simply say on Jan 1st: sorry but it's not working commercially. They then don't have to start the 8000 patient trial and they take a the write off. I say all this by pure speculation. I don't know much about this trial or how much it will cost but it does seem to be the most expensive Afrezza thing out there for the next year or so. It's a 'FDA Trojan horse' that I noticed right after FDA approval which really bothered me at the time and that still bothered me every time I checked trial status updates. I was so hoping to see that puppy start up. The small trials (# of participants) they have done so far are nice but nowhere near significant in terms of $ costs. Look at how much the (often low quality i.e. Russia) trials Mannkind has done so far cost. I really doubt safety trials should or will be done in Russian smokers! Even the peds trials gave me pause. They started off really slowly with microscopic phase 1 trials. Look at the number of patients involved. We are a very long way from phase 3 peds trials...
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Post by mbseeking on Nov 10, 2015 18:25:49 GMT -5
But MNKD has forced SNY' s hand now on the long term trial - and their long term commitment. I'm not convinced with Brandicourt at the helm that is the best outcome but SNY know they cant let Afrezza get away from them. I'm sure they'd calculated that MNKD was about to go broke and had been threatening too walk, delaying the big trial. Now they cant. And now they have to spend fresh real money , not sunk at the time of original deal , then SNY's shareholders will expect it to pay back.. So SNY may even have to get a hurry on with the insurance coverage now.... Not saying this will happen but why can't they simply say on Jan 1st: sorry but it's not working commercially. They then don't have to start the 8000 patient trial and they take a the write off. I say all this by pure speculation. I don't know much about this trial or how much it will cost but it does seem to be the most expensive Afrezza thing out there for the next year or so. It's a 'FDA Trojan horse' that I noticed right after FDA approval which really bothered me at the time and that still bothered me every time I checked trial status updates. I was so hoping to see that puppy start up. The small trials (# of participants) they have done so far are nice but nowhere near significant in terms of $ costs. Look at how much the (often low quality i.e. Russia) trials Mannkind has done so far cost. I really doubt safety trials should or will be done in Russian smokers! Even the peds trials gave me pause. They started off really slowly with microscopic phase 1 trials. Look at the number of patients involved. We are a very long way from phase 3 peds trials... I believe Brandicourt's SNY understands exactly how transformative Afrezza is. The very last thing they would want would be let it go now for a competitor. But they've been doing as little as they could knowing MNKD's financial situation (arguably exacerbated as MNKD tries to build a firewall against the shorts). Dragging things out in the hope of buying out the rights to Afrezza , or more. But the TASE deal now just short circuited that. What's more , most of the remaining milestone payments are related to sales / development - as opposed to production, which are all on SNY side. IF those payments dont happen MNKD can take their bat and ball somewhere else. I'm not fearful of that situation at all, but SNY just might be. So not only does this TASE deal start the end play for the shorts, it also flushes out SNY. We might just now start to see some action from the French.
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Post by patryn on Nov 10, 2015 18:31:46 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 ?? No but I might be looking for a new house soon!
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Post by kc on Nov 10, 2015 18:32:26 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. Buy or Buy In. Surprised they have not done it. YET.
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Post by jpg on Nov 10, 2015 18:34:00 GMT -5
Not saying this will happen but why can't they simply say on Jan 1st: sorry but it's not working commercially. They then don't have to start the 8000 patient trial and they take a the write off. I say all this by pure speculation. I don't know much about this trial or how much it will cost but it does seem to be the most expensive Afrezza thing out there for the next year or so. It's a 'FDA Trojan horse' that I noticed right after FDA approval which really bothered me at the time and that still bothered me every time I checked trial status updates. I was so hoping to see that puppy start up. The small trials (# of participants) they have done so far are nice but nowhere near significant in terms of $ costs. Look at how much the (often low quality i.e. Russia) trials Mannkind has done so far cost. I really doubt safety trials should or will be done in Russian smokers! Even the peds trials gave me pause. They started off really slowly with microscopic phase 1 trials. Look at the number of patients involved. We are a very long way from phase 3 peds trials... I believe Brandicourt's SNY understands exactly how transformative Afrezza is. The very last thing they would want would be let it go now for a competitor. But they've been doing as little as they could knowing MNKD's financial situation (arguably exacerbated as MNKD tries to build a firewall against the shorts). Dragging things out in the hope of buying out the rights to Afrezza , or more. But the TASE deal now just short circuited that. What's more , most of the remaining milestone payments are related to sales / development - as opposed to production, which are all on SNY side. IF those payments dont happen MNKD can take their bat and ball somewhere else. I'm not fearful of that situation at all, but SNY just might be. So not only does this TASE deal start the end play for the shorts, it also flushes out SNY. We might just now start to see some action from the French. Did you listen to the Sanofi CC last Friday? If so were you not worried by the 'need to cut and focus' and by the lack of mention of Afrezza while the slides barely mentioned Afrezza? If not listen to the call (better than reading in my mind) and tell me if this moves your perspective. Thank you.
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Post by mnkdorbust on Nov 10, 2015 18:43:14 GMT -5
My personal though is the new allegations against Sanofi that just hit the press will also add pressure. If they were "kind of" sandbagging Afrezza I would think between the TASE deal and the extra scrutiny being put on by allegations, it could also have impact. I don't feel Sanofi will or would want to exit the partnership but i also never expected to be buying MNKD stock at 2.30 a share after approval and Afrezza being on the market.
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Post by patryn on Nov 10, 2015 18:47:00 GMT -5
But MNKD has forced SNY' s hand now on the long term trial - and their long term commitment. I'm not convinced with Brandicourt at the helm that is the best outcome but SNY know they cant let Afrezza get away from them. I'm sure they'd calculated that MNKD was about to go broke and had been threatening too walk, delaying the big trial. Now they cant. And now they have to spend fresh real money , not sunk at the time of original deal , then SNY's shareholders will expect it to pay back.. So SNY may even have to get a hurry on with the insurance coverage now.... Not saying this will happen but why can't they simply say on Jan 1st: sorry but it's not working commercially. They then don't have to start the 8000 patient trial and they take a the write off. I say all this by pure speculation. I don't know much about this trial or how much it will cost but it does seem to be the most expensive Afrezza thing out there for the next year or so. It's a 'FDA Trojan horse' that I noticed right after FDA approval which really bothered me at the time and that still bothered me every time I checked trial status updates. I was so hoping to see that puppy start up. The small trials (# of participants) they have done so far are nice but nowhere near significant in terms of $ costs. Look at how much the (often low quality i.e. Russia) trials Mannkind has done so far cost. I really doubt safety trials should or will be done in Russian smokers! Even the peds trials gave me pause. They started off really slowly with microscopic phase 1 trials. Look at the number of patients involved. We are a very long way from phase 3 peds trials... Sunk cost. SNY has already put most of what they need to put into Afrezza that they will not back out over this trial. They knew the trial was one of the things that needed to be done when they entered into the partnership agreement. They stand to gain most of the benefit from Afrezza sales if it takes off and any losses at this point going forward are fairly minimal while they wait to see the uptick in prescription count. Worst case this is a get out jail free card for Brandicourt. If it fails he can just blame his predecessor and write it off, and if it succeeds, it will be seen as one of the ways he re-organized SNY to be more streamlined and more focused on their diabetes operations. SNY really did get a great deal since the upfront payment was only about 15% of the total payout and if the total payout happens, it's because they stand to gain billions from it.
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Post by mbseeking on Nov 10, 2015 18:47:00 GMT -5
Absolutely heard it and was as disappointed as everyone. But everything is about signalling and the juxtaposition of conference calls (especially the late announcement of MNKDs) tells me there has been a lot of signalling going on just lately between SNY and MNKD. Well rather than roll over and play dead, MNKD just told SNY they have enough money to survive , and hey buddy , you got to start doing some serious stuff (trials - big one started by March , coverage) with our product or we get someone else ( because most of the future milestone payments are all on SNYs side) .
I do belive SNY would be fearful if they lost Afrezza. MNKD has just shown it can survive at least another 12 months. All the effort to validate the deal in the next 6 months has to come from SNY.
Think of it this way. When SNY did their Meet Management they would have prepared that package thinking MNKD was over a barrel. Yes, TASE announce come out just before but too close for SNY to assimilate. MNKD didn't do their CC until after that to announce the 50M new shares of capital infusion. MNKD flushed SNY out and called them.
I'm sure Brandicourt can tweak his strategy.
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Post by rrtzmd on Nov 10, 2015 20:44:10 GMT -5
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Post by rrtzmd on Nov 10, 2015 20:53:11 GMT -5
Basically it all rests one reading the intentions of Sanofi. The 8000 patient safety study which should be finalized April 30th with the FDA could be an interesting financial 'spending opportunity' to look at. I don't know how much it will cost or how they will structure it but if the FDA insists on a truly randomized 5 year trial that is big $. Maybe they just mean case controlled (which is much much cheaper). Agreed Sanofi can't afford to have a 2nd public sandbagging fiasco on their hands though. Details of the safety study: "Conduct a 5-year, randomized, controlled trial in 8,000-10,000 patients with type 2 diabetes to assess the serious potential risk of pulmonary malignancy with Afrezza use. The primary objective of the trial should be to compare the incidence of pulmonary malignancy observed with Afrezza to that observed in the standard of care control group. Secondary endpoints should include mortality due to pulmonary malignancy and all-cause mortality. Randomization to Afrezza or standard of care should be 1 to 1. The patient population should be enriched with respect to lung cancer risk (i.e., predicted incidence of no less than 200/100,000 patient-year). The potential for detection bias should be adequately addressed in the trial design. Subjects who discontinue randomized intervention due to lack of efficacy or tolerability issues should continue to be followed for the outcomes of interest and prospective measures to encourage subject retention and capture outcomes in patients who withdraw or are lost to follow-up should be in place. Glucose control and glycemic rescue should be per standard of care. The trial must also include an assessment of cardiovascular risk based on prospectively defined, collected and independently adjudicated major adverse cardiovascular events or MACE (i.e., cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke). Also include as part of the trial a substudy (also with 1 to 1 randomization to either Afrezza or standard or care) to evaluate the long-term effect of Afrezza on pulmonary function. Patients in the substudy should have pulmonary function tests at baseline and every 6 months until end of treatment. The timetable you submitted on June 23, 2014 , states that you will conduct this trial according to the following schedule: Final Protocol Submission: April 2015 Trial Completion: April 2023 Final Report Submission: December 2023" That's the first time I noticed that the safety trial was restricted to type 2 patients. Why? Do they think type 1s are immune to cancer?
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Post by mnholdem on Nov 10, 2015 20:55:29 GMT -5
Long-term lung safety study was advocated by several attending physicians at ADCOM who voiced a concern about the long-term effect of inhaling FDPK particulates loaded with human insulin. Evidence does exist from post-marketing study of Exubera, and it is positive, but both the delivery vehicle and the passenger are different with Afrezza so the safety study has merit, PLUS it should be useful for providing data relevant to other future Technosphere drugs.
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Post by harryx1 on Nov 10, 2015 23:18:37 GMT -5
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 Hey stevil - Just curious, are you associated with ChimeraResearchGroup? www.chimeraresearchgroup.com/our-team/
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Post by jpg on Nov 10, 2015 23:45:32 GMT -5
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 Hey stevil - Just curious, are you associated with ChimeraResearchGroup? www.chimeraresearchgroup.com/our-team/That is one more extraordinary find (not that it is in the least surprising though)... Another troll/ spammer unmasked! For some reason I have a feeling our 'medical student' will not hang out here (under his current name at least) anymore. I wonder how many of these trolls populate this board? Or is it always the same guy using a bunch of aliases?
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Post by hankscorpio7 on Nov 10, 2015 23:54:27 GMT -5
A great way to tell people apart are their ears. All white people look the same harryx1?
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