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Post by ashiwi on Jun 13, 2015 20:37:55 GMT -5
The trial also puts to bed the talk of SNY abandoning Afrezza. More than ever, with the ADA booth, presentations, and this trial, SNY is 100% behind Afrezza and is determined to make it the blockbuster that it will ultimately be.
Also on another note, sorry Spiro, but Liane and BD gave me 10,000 shares to be a Global Monitor. Don't tell them but I lent the shares out.
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Post by Deleted on Jun 13, 2015 20:38:16 GMT -5
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Post by oscarlonzo on Jun 13, 2015 22:49:42 GMT -5
"...will allow them to term the drug ultra-fast acting ..."
Where did Sanofi or MNKD say that? Why didn't the PD/PK studies done for FDA approval already show that. The drug insert even includes graphs of the PK/PD results. If it wasn't "ultrafast" before , what about this study will make any difference? No, I think it's because SNY is concerned about increasing reports that users are having to use a lot more afrezza in order to match their old lispro doses. Insurers don't like paying for 2 or 3 doses when one works as well. SNY is thinking about reimbursement.
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Post by oscarlonzo on Jun 13, 2015 22:54:15 GMT -5
"I asked him to back it up or risk losing credibility ..." I beg your pardon but I pointed out that I quoted directly from the proxy: proxy
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Post by oscarlonzo on Jun 13, 2015 23:01:37 GMT -5
"Well, finally something exciting happening."
Why hasn't either Sanofi or Mannkind said anything about it? The ADA meeting would have been a perfect place to announce an upcoming trial trying to demonstrate whatever.
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Post by jpg on Jun 13, 2015 23:08:30 GMT -5
"...will allow them to term the drug ultra-fast acting ..." Where did Sanofi or MNKD say that? Why didn't the PD/PK studies done for FDA approval already show that. The drug insert even includes graphs of the PK/PD results. If it wasn't "ultrafast" before , what about this study will make any difference? No, I think it's because SNY is concerned about increasing reports that users are having to use a lot more afrezza in order to match their old lispro doses. Insurers don't like paying for 2 or 3 doses when one works as well. SNY is thinking about reimbursement. That is the type of study that would demonstrate ultra fast. Reading your last few posts you will have to up your game a bit.
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Post by oscarlonzo on Jun 13, 2015 23:37:32 GMT -5
"another reason they are running this trial:"
Could be but if they were doing it for EMA approval, why wouldn't they have announced something about it? Like I said above, the ADA meeting would have been the perfect place to announce something like that.
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Post by oscarlonzo on Jun 13, 2015 23:44:15 GMT -5
"That is the type of study that would demonstrate ultra fa st."
What kind of study do you think they did to collect the PD data shown in the insert? Euglycemic clamp. The only thing new is that they are doing it for three different doses. How would doing it for three different doses show anything different for the single dose used for the insert. The insert was based on 8U so I presume the two others will be 4 and 12. I recall that they said in either the insert or FDA document that there was a difference in effect of different doses -- they weren't proportional so that 8 didn't produce twice the effect 4, etc. That may another possibility, but to demonstrate ultrafast I doubt.
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Post by Deleted on Jun 14, 2015 4:17:38 GMT -5
I find it ironic that in what could be the most important piece of news since partnering, you decide to spam the thread with nothing more than an ambiguous line of questioning.
Anyway, i believe they are going up against Humalog for three reasons:
1) it's the path for ema approval 2) their prior clinical work was against aspart 3) to gain differentiation from a competitor 4) label change towards "ultra"
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Post by liane on Jun 14, 2015 5:24:43 GMT -5
I was thinking MNKD had already performed a euglycemic clamp study; and they had: clinicaltrials.gov/ct2/show/NCT01544881?term=diabetes+and+mannkind&rank=8The MNKD study involved 17 participants and utilized a single dose of 20 u TI vs 8u RAA. The SNY study will involve 30 participants receiving 3 different doses each of TI vs lispro. The study allows a washout period of anywhere between 1 week and 1 month between trial doses (preferably 1 week). There is an initial screening period of up to 28 days, and a follow-up period of 14 days. Thus, it can take up to 7.5 months for any individual to complete. So, I'm wondering if the EU requires a euglycemic clamp study for each individual dosage, and if this is what's been holding up the EU submission.
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Post by gomnkd on Jun 14, 2015 7:16:11 GMT -5
My two cents: 1) Warren Buffett says options are a form a compensation. This is dilution and transfer of ownership from existing holders to BoD. Yes, BoD are paid more than 1/2MMM a year. It doesn't become an issue if BoD never sell it and option expires before expiry. I don't think that is happening every time. I've no idea what value MNKD got in return. I trust Al Mann's judgment to do the right thing. 2) I'm on Liane's camp thinking this is for EU. At this point SNY/MNKD is just keen on getting this approved in other countries, rather than spending time in proving superiority. They've tried and have been unsuccessful in convincing FDA. This euglycemic clamp study (for PD) has been done numerous times. This is even done generally in Phase 2. In fact, 6 studies were done clinicaltrials.gov/ct2/results?term=Mannkind+and+clamp&Search=SearchI really dont know what else MNKD needs to do to show superiority. We've a clearly differentiated PK profile. That doesn't mean much in terms of insulin action (It may suppress liver secretion and improve resistance, but these are not measured). We have a PD profile that doesn't look much different at first glance. FDA categorically says this is undifferentiated. Click on pics to see it better. Attachment DeletedLook at yellow highlight. But I drew a vertical line to show how different the GIR (the PD thing) is (I did this a year back in other MNKD forum). Attachment DeletedThe GIR is just not the same, at least during the initial period when it really matters (suppression of EGP etc). Attachment DeletedAt this point, I've given up hope for agencies to say Afrezza is an ultra fast acting insulin. I take comfort from the fact that ,the only folks who matter - Patients are resoundingly saying that Afrezza is ultra fast acting.
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Post by jpg on Jun 14, 2015 8:13:10 GMT -5
"another reason they are running this trial:" Could be but if they were doing it for EMA approval, why wouldn't they have announced something about it? Like I said above, the ADA meeting would have been the perfect place to announce something like that. Why would the ADA be the perfect place to announce something like that? On the contrary I believe clinicians mostly couldn't care less about this stuff. The ADA was to introduce Afrezza to clinicians not regulators. They are doing the study for whatever reason (and with the new inhaler) and these studies certainly could have more then one use. I can't see why they wouldn't resubmit to the FDA (done with new inhaler) and try that again while getting their ducks in a row for overseas. Again why is the place and way they announce this study material? Isn't the fact they are doing it what counts and the rest marketing? You are saying you don't agree with the marketing of this 'announcement' and as I said above I think the ADA would have been a terrible time and place to announce this type of study. Few if any would have cared and most clinicians and advocates would have been mostly distracted and puzzled by this clinically not very meaningful piece of info. And you want Sanofi to explicitly tell their competition why they are doing this while distracting clinicians from the real stuff? I don't, as usual follow your pessimistic interpretation of every piece of news about Mannkind.
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Post by liane on Jun 14, 2015 8:21:54 GMT -5
Meetings like the ADA are where you announce results, not necessarily the initiation of a study.
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Post by Deleted on Jun 14, 2015 8:36:19 GMT -5
Meetings like the ADA are where you announce results, not necessarily the initiation of a study. Hopefully the results will be available for the next year's ADA
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Post by oscarlonzo on Jun 14, 2015 9:31:54 GMT -5
"I find it ironic that in what could be the most important piece of news since partnering,"
Well, I find it "ironic" that neither MNKD nor SNY would choose to say a single word about the alleged "most important news since partnering" despite it coming on the heels of the ADA meeting. Especially after headlines like "MannKind Corporation Sinks: CFO Says 'We're Not There Yet' With Afrezza."
Someone else said "Meetings like the ADA are where you announce results, not necessarily the initiation of a study." Well, maybe "not necessarily," but there certainly isn't any rule against it and especially when your company's name appears on the "5 Stocks a Raging Rally Could Not Save" list.
And someone else said "I believe clinicians mostly couldn't care less about this stuff." So what? It's not the clinicians your addressing, it's the people behind "The 6 Most Shorted Nasdaq Stocks in May."
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