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Post by longinvstr on Dec 2, 2015 11:20:11 GMT -5
The student becomes the teacher? If SNY/MNKD wanted a label change (obvious), input from early adopters (experience, strategies, AND DATA) seems a great place to begin for study design.
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Post by dreamboatcruise on Dec 2, 2015 11:45:57 GMT -5
I find it interesting that this comes on the heels of Sanofi's completion of two FDA's postmarket trials for Afrezza. The data from both trials are related to dosing. Afrezza Postmarket Requirement/Commitment #2 on the FDA website states: "These data may impact labeling recommendations for dosing..."The data from those trials is loosely related to dosing... it's dosing for those people that consume their carbs by having it injected directly into their blood stream as glucose, and where it is the glucose that is variably dosed, not the Afrezza  If I were SNY this early adopter meeting is exactly what I would be doing to design a trial to show superiority. They need to figure out real world dosing protocols that work for as wide of a range of patients, and individual dietary practices, as possible. This took a lot longer than I would have thought, but is exactly what I was hoping to see to indicate that the "focused" (rather than lame) initial launch had a purpose. Last paragraph qualifies in the "hope" and "change we can believe in" category... as long as the previous suggestion by someone here that the early adopters are being gathered to be told that Afrezza is going the way of Exubera is not the purpose. I also "hope" MNKD can finance itself without painful amounts of dilution while Sanofi goes about the work of turning Afrezza into a blockbuster equaling or surpassing their success with Lantus. |
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Post by ripano on Dec 2, 2015 11:53:19 GMT -5
Let's try to limit the infamous words of " Hope and change we can believe in "
Thank You
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Post by jmerr on Dec 2, 2015 12:00:45 GMT -5
Hi Spiro, J merr here -- I don't post often but read almost everything-- Have been in it from the beginning and hold way more than I should as a percentage of my portfolio. Where exactly will the meeting take place. I am in Orange county-- May run down there for the weekend and see what I can see. |
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Post by mssciguy on Dec 2, 2015 12:02:56 GMT -5
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Post by dreamboatcruise on Dec 2, 2015 12:10:41 GMT -5
cjc04... FDA trials to improve the label would very likely have to have some protocol for dosing. The FDA does not like to assume that every patient is as smart as Sam or Matt and figures out their own methods. Many in the real world may be smart enough and motivated enough to do so, but likewise it is reality that many will not. Not to mention that from a scientific standpoint it's much harder to figure out what's going on if people are just doing their own thing rather than following a script. From what I've seen it appears that very effective protocols using CGMs or frequent blood testing are possible... but will FDA feel those are useful when insurance in general doesn't cover CGM and even skimps on test strips. Our friend Spiro also reveals that the protocol may be as simple as can be if Afrezza were used early in treatment... but will the FDA buy into that or is it breaking with the current status quo too much. I'm curious as heck to see how these trials (assuming we get them soon) are constructed. Will there be multiple trials or arms that have different dosing protocols? Anything related to that Google effort is likely to be a long way from making its way into any FDA approval. The concept of "mining" data is not something that is accepted by the medical community... i.e. the FDA has no precedence or procedures to take mined data of thousands of patients doing different methods of dosing and eating and derive conclusions that would be put on a label. Current trials are based on a hypothesis and an agreed on test of that hypothesis... i.e. "does a particular dosing protocol reduce A1c" or "does a particular dosing protocol produce non-inferior A1c". It's very different to look at tons of data and have algorithms predict what might lower A1c the most.
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Post by compound26 on Dec 2, 2015 12:12:22 GMT -5
Hi Spiro, J merr here -- I don't post often but read almost everything-- Have been in it from the beginning and hold way more than I should as a percentage of my portfolio. Where exactly will the meeting take place. I am in Orange county-- May run down there for the weekend and see what I can see. Quoting the earlier post: Post by hammer Here is the original post from YMB: oxotnik1 • 11 hours ago This Friday, Dec 4th, SNY flying initial adopters to San Diego's Del Mar Hilton for weekend meetings with scientists from SNY and UCSD. Topics include dosing and who knows what else. This would not be happening if SNY planned to drop MNKD. I will get updates and let all know next week. Afrezza user posted this comment on Twitter this AM: Afrezzauser afrezzauser · 1h1 hour ago On way to San Diego till Dec 6th! If anyone would like to meet I will try to do it. Send private message. #afrezza Read more: mnkd.proboards.com/post/49832 |
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Post by sweedee79 on Dec 2, 2015 12:20:15 GMT -5
Wow.. this is interesting and it appears to be true.. If the data on the recently completed studies is related to dosing that is important. Right now they are saying that Afrezza and injectable insulin are the same dose for dose... NOT TRUE...It is different for each patient and many patients require higher doses of Afrezza compared to injectable. I believe they had to say that because of non-inferior status and the way they were forced to run the trials for the FDA .. this is one step toward label change and the proper dosing and prescribing of Afrezza...
My dad is going off of Afrezza until a later date as he got very tired of all of the trouble he was having... doctors weren't cooperating.. fearful and lacking in knowledge... and also skeptical and not wanting to change what they do now.... they didn't want to raise his dose and instead blamed him for not eating right when it was obvious that he NEEDED A HIGHER DOSE... the last straw was when his part D coverage removed Afrezza from its formulary for 2016... He LOVES Afrezza ...he feels better on it.. more energy and he has lost a lot of weight.. says he feels sluggish on Novolog and he will gain the weight back.. but until the docs know what they are doing it is a real pain in the butt... some people have criticized me and said just go to another doc... this is a small rural area and there are very few doctors.. we have been to the largest hospitals in the area.. My dad is 75 and set in his ways... he just got tired of it... when the docs know what they are doing and insurance coverage is good he will RUN to get his Afrezza back ...
Dosing IS and an issue and lack of knowledge as well as insurance coverage.... Its been like having to BUST DOWN THE DOOR in a gated community that doesn't want to let you in.. I don't know how else to describe it ... but that is what it has been like for us... and I am sure it has been this way for others as well... I know how good this drug is.. and I want my dad back on Afrezza again SOON... because I believe in it so much... Just hope Afrezzauser and others going to San Diego shed some light on this to the SNY team... and that this in combination with the completed studies will be enough to get a label change...
That is why I believe a full blown launch in the beginning would have been a big mistake for SNY and MNKD ... it has been a very smart move on their part to seek label changes first and better representation of Afrezza ... I do however wish that things could have moved a bit faster as it has left us investors and also some patients(my dad) out here without much support and blind to what is going on ... fending for ourselves.. |
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Post by saxcmann on Dec 2, 2015 12:31:12 GMT -5
Yes, higher dose is needed Sweedee and Sanofi knows this. 20U is recommended by my source. Training for doctors speaking start February 2016. I personaly think clamp studies were needed for EMA filing.
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Post by cjc04 on Dec 2, 2015 12:43:07 GMT -5
cjc04... FDA trials to improve the label would very likely have to have some protocol for dosing. The FDA does not like to assume that every patient is as smart as Sam or Matt and figures out their own methods. Many in the real world may be smart enough and motivated enough to do so, but likewise it is reality that many will not. Not to mention that from a scientific standpoint it's much harder to figure out what's going on if people are just doing their own thing rather than following a script. From what I've seen it appears that very effective protocols using CGMs or frequent blood testing are possible... but will FDA feel those are useful when insurance in general doesn't cover CGM and even skimps on test strips. Our friend Spiro also reveals that the protocol may be as simple as can be if Afrezza were used early in treatment... but will the FDA buy into that or is it breaking with the current status quo too much. I'm curious as heck to see how these trials (assuming we get them soon) are constructed. Will there be multiple trials or arms that have different dosing protocols? Anything related to that Google effort is likely to be a long way from making its way into any FDA approval. The concept of "mining" data is not something that is accepted by the medical community... i.e. the FDA has no precedence or procedures to take mined data of thousands of patients doing different methods of dosing and eating and derive conclusions that would be put on a label. Current trials are based on a hypothesis and an agreed on test of that hypothesis... i.e. "does a particular dosing protocol reduce A1c" or "does a particular dosing protocol produce non-inferior A1c". It's very different to look at tons of data and have algorithms predict what might lower A1c the most. The idea that the FDA is comfortable with injection dosing and concerned with Afrezza dosing is a joke.... Diabetics are just guessing every day with injections and have very little control, and serious hypo risks. As for the Google deal, I wasn't suggesting anything would come of that anytime soon (other than maybe a mention of Afrezza and/or MNKD which could show commitment to MNKD).... I was just curious about Googles involvement is all......... Now that I think of it, the timing of this meeting with patients to gather info is interesting. Isn't the Google deal supposed to start next month? Be nice if there were a connection there.. Hmmm,,, and doesn't the 8,000 patient study have some Jan date attached to it,,, or am I making that up? |
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Post by james on Dec 2, 2015 13:00:35 GMT -5
This meeting may help explain something that has been nagging me for some time now. The challenge group that Sam was administering went dark at the end of July and very little has been heard of the results from these participants since that point. I have been wondering if the data collection for this may have come under more formal control, which is what I thought should be happening shortly after the group was assembled. There may have been something of a trial run here out of public view with the intent to formally publish new results. The San Diego meeting could be a capstone to that activity to gather the experiential feedback of the group. If that's not what's going on then fine, but I think this meeting is a positive development in any case.
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Post by Deleted on Dec 2, 2015 13:02:58 GMT -5
Yes, higher dose is needed Sweedee and Sanofi knows this. 20U is recommended by my source. Training for doctors speaking start February 2016. I personaly think clamp studies were needed for EMA filing. At this point in time, the Technosphere platform would allow for up to 36U on a cartridge. At I believe 24U and above, there is some different technology although not sure exactly what it is. Sanofi Google partnership has one more component which is the Google Dexcom partnership. The newest Dexcom sensor, the G5 sends data directly from the sensor to a smartphone. dexcom.com/media/dexcom-g5-mobile-cgm-systemGoogle is playing around a bit with a contact lens that measures glucose levels but as you all know, what Google is most proficient at is data analysis. Dexcom and Google are working on another sensor that will have a much lower price point, be smaller in diameter than a quarter and distributed at retail pharmacies. With news being reported that UHC will have Afrezza on formulary 1-1-16, maybe Sanofi works with UHC to put 1000 type 1s on Afrezza and the G5 sensor system for 9 months and tests A1c every 6 weeks to show a before & after. I know we need trials etc for label change, but something like this would not be all that expensive and increase the awareness of the Afrezza value proposition exponentially. |
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Post by ashiwi on Dec 2, 2015 13:05:07 GMT -5
With Afrezza, it can be very simple. Depending on how many carbs you are eating and how big of a meal, it may require a follow up dose of 4 or more units an hour after your meal.
Using insulin whether injected or inhaled is based on science, but it's an art when it comes to dosing and can vary with each meal. There is a learning curve to get it right.
That's what this meeting in San Diego is all about. Experienced users will discuss their protocols. Continuous glucose monitoring makes it real simple.
As most of us already know, Afrezza is very quick acting and leaves the body faster than injected insulin. It will prevent the immediate glucose spikes which come with eating. Since a larger meal can linger in your system longer, it may require of follow up dose of Afrezza to keep your glucose level in check. Preventing glucose spikes not only ultimately lowers your A1c, but protects your organs (eyes, kidneys, nerves) from damage.
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Post by mnholdem on Dec 2, 2015 13:05:43 GMT -5
I also "hope" MNKD can finance itself without painful amounts of dilution while Sanofi goes about the work of turning Afrezza into a blockbuster equaling or surpassing their success with Lantus. Well... there is a way that Sanofi can help in that regard. There's a little know clause in the License & Collaboration Agreement in which Sanofi and MannKind can agree that for all sales in any particular territory (country) the parties can opt out of the 65/35 profit sharing arrangement and royalty payments would be made to MannKind by Sanofi for all sales of Afrezza in those territories.
In other words, Sanofi can sell Afrezza to a "Royalty Country" and MannKind does not have to pay any expenses, which could help bring in much needed cash. Sanofi and MannKind could agree on some royalty countries in the middle east, such as Saudi Arabia, Israel and others.
Just a thought... in the event that my expectation of a major share price increase doesn't materialize anytime within the next twelve months. 
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Post by dreamboatcruise on Dec 2, 2015 13:22:14 GMT -5
Yes, higher dose is needed Sweedee and Sanofi knows this. 20U is recommended by my source. Training for doctors speaking start February 2016. I personaly think clamp studies were needed for EMA filing. At this point in time, the Technosphere platform would allow for up to 36U on a cartridge. At I believe 24U and above, there is some different technology although not sure exactly what it is. Sanofi Google partnership has one more component which is the Google Dexcom partnership. The newest Dexcom sensor, the G5 sends data directly from the sensor to a smartphone. dexcom.com/media/dexcom-g5-mobile-cgm-systemGoogle is playing around a bit with a contact lens that measures glucose levels but as you all know, what Google is most proficient at is data analysis. Dexcom and Google are working on another sensor that will have a much lower price point, be smaller in diameter than a quarter and distributed at retail pharmacies. With news being reported that UHC will have Afrezza on formulary 1-1-16, maybe Sanofi works with UHC to put 1000 type 1s on Afrezza and the G5 sensor system for 9 months and tests A1c every 6 weeks to show a before & after. I know we need trials etc for label change, but something like this would not be all that expensive and increase the awareness of the Afrezza value proposition exponentially. I didn't know UHC formulary was in the news. I've seen speculation about their "formulary" on this board, but that is not "news"... generally speculation from people that don't even recognize that a large insurer like that has many different plans and formularies not just a single one. There were about 7% of UHC patients that had unrestricted coverage this past year (as per formularylookup.com) and no one has presented any evidence to suggest that the situation will improve on Jan 1. In fact the speculation seems to stem from one person on twitter that announced he was happy that his co-pay would be only $45 with UHC in 2016... failing to acknowledge it had been $45 in 2015 as well (that can be found in his twitter history, however). Not complaining that he's happy the co-pay is staying the same... but his tweet was grossly misinterpreted by many. |
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