|
|
Post by sweedee79 on Dec 3, 2015 0:19:36 GMT -5
Hey KBALL... Yes I'm posting here too now and I enjoy it... sometimes the YMB board gets a lil crazy... I love the people on Twitter, they are very supportive .. and yes we have many obstacles to climb, none of which many of us saw coming .. It would have been nice if we had a heads up, but such is life in the stock market.. particularly high risk speculative bio techs... but Afrezza is amazing.. many really good people behind this great product. So at this point I choose to remain positive.. Dr. Steven Edelman has been working with Sanofi .. and coincidentally he lives in San Diego .. He is also a diabetic whom supports the idea of inhaled insulin .. he has been diabetic since he was 15 and has devoted his life to helping people with diabetes.. It is possible he is at this meeting in San Diego with the early adopters.. makes sense to me..
anyway... Goodnight All.. |
|
|
|
Post by stevil on Dec 3, 2015 0:58:55 GMT -5
patentimages.storage.googleapis.com/WO2014012069A2/imgf000056_0001.pngIn a way, it is carbon coated, but you're right, it is WAAAAY simplified. For instance, CO (carbon monoxide), is not a safe molecule to inhale. It binds to hemoglobin in the blood and inhibits its ability to bind oxygen, essentially suffocating a person who inhales it. Hydrocarbons in gasoline eventually burn into CO2 and H2O. I'm sure many here know that we exhale CO2, but it can actually cause acidosis if we inhale too much of it back into our body. So carbon is actually not always ok to inhale. We'd actually be better off if we never inhaled it. The only time I can think that it would be beneficial to inhale carbon (other than medication of course) is during hyperventilation. You blood can actually become alkaline, so inhaling CO2 prevents alkalosis. Sorry for the science lecture. Figured I'd make use of info that feels worthless right now and share it with others. So, he's right about it being carbon coated, but incorrect about that being the reason why it's ok to inhale Afrezza.
|
|
|
|
Post by stevil on Dec 3, 2015 1:21:08 GMT -5
This is very simplistic reasoning and does not fall in line with reality based on the fact that many commonly prescribed drugs are inhaled for many common conditions - used daily (e.g. Asthma) Asthma drugs help open the airway ( helps the lungs function) Not any where close to inhaling of other particles. It looks like others have piled on enough. Sorry to say it, but what you stated was incorrect. Just because you can't see them, doesn't mean you're not inhaling particles 100% of the time. Atmospheric air is mostly composed of nitrogen and oxygen and other trace elements, mostly particulates and other gases. You inhale dust with every breath. If you live in an urban area, there's a good chance you're inhaling the brake dust from people's brake pads. Think about how random that is... Now think about all the other things you're inhaling if you're inhaling those things... linkyI did a quick search and if you want to do research into what particles you inhale and how bad your city is, click here. Next, those asthma drugs you referenced. Look up Advair diskus inhalers. Better yet, I did it for you. Notice what it says at the bottom of the description. Inhalation POWDER. Advair is usually used for people with COPD, although it can be used for asthma too. If you think about it, you can't inhale something and get an effect from it without particles entering your lungs. Unless you live in a vacuum, you're always going to inhale something. |
|
|
|
Post by EveningOfTheDay on Dec 3, 2015 2:32:51 GMT -5
If anyone has channel to some of these Afrezza users invited to SD, I'd be really curious whether SNY has previously asked them to log data about dosing, diet, etc. and if so for how long... and is it being provided to SNY on a regular basis. DBC, I reached out to one of the well know early adopters, not Finta though, and he told me he is heading out for San Diego on Friday and will be there for the weekend. He also mention that he could not comment on the gathering or give me any information as he is "under contract to keep it quiet for now", his words not mine. I was curious to know for how long he has been under this confidentiality contract so I sent him another email asking him about it. If he does answer I will let you know, but it would make sense, as someone postulated in this forum, that they have been providing Sanofi with data for a while and that is the reason why Sam has not updated his blog since July. |
|
|
|
Post by dreamboatcruise on Dec 3, 2015 2:45:42 GMT -5
If anyone has channel to some of these Afrezza users invited to SD, I'd be really curious whether SNY has previously asked them to log data about dosing, diet, etc. and if so for how long... and is it being provided to SNY on a regular basis. DBC, I reached out to one of the well know early adopters, not Finta though, and he told me he is heading out for San Diego on Friday and will be there for the weekend. He also mention that he could not comment on the gathering or give me any information as he is "under contract to keep it quiet for now", his words not mine. I was curious to know for how long he has been under this confidentiality contract so I sent him another email asking him about it. If he does answer I will let you know, but it would make sense, as someone postulated in this forum, that they have been providing Sanofi with data for a while and that is the reason why Sam has not updated his blog since July. That would make sense potentially regarding Sam... I had wondered what was up, or not. Of course whatever seems to make sense regarding MNKD and Afrezza always seems to have some twist worthy of Hitchcock or M. Night. |
|
|
|
Post by mnholdem on Dec 3, 2015 9:10:19 GMT -5
Dexcom has been working with Google to develop inexpensive Continuous Glucose Monitors and they also happen to be headquartered in San Diego. Now that Sanofi has teamed up with Google Life Sciences, it would be an awesome combination to combine Afrezza with inexpensive monitoring for exceptional and needle-free diabetes control.
diatribe.org/google-and-dexcom-team-dramatically-improve-cgm
Excerpt:
"In breaking news, Dexcom and Google just announced today that they have joined forces to develop a next generation of continuous glucose monitors (CGM) that will be smaller and less expensive than current offerings. We learned from Dexcom’s conference call this morning that the vision is a flexible, low-cost, bandage-like, disposable CGM product (approximately the size of a dime!) worn for 10-14 days. It would likely communicate to a nearby smartphone app, allowing very convenient viewing of glucose data. The goal is for a first version to launch in two to three years, with a follow-up product to come out within five years."
www.prnewswire.com/news-releases/dexcom-to-collaborate-with-the-life-sciences-team-at-google-on-the-development-of-breakthrough-technologies-to-change-the-future-of-diabetes-management-300126661.html
Excerpt:
"This partnership has the potential to change the face of diabetes technology forever," said Kevin Sayer, President and Chief Executive Officer of DexCom. "Working together, we believe we can introduce products that will move us beyond our core Type 1 business to become the standard of care for all people living with diabetes."
"We're committed to developing new technologies that will help move health care from reactive to proactive," said Andrew Conrad, head of the life sciences team at Google. "This collaboration is another step towards expanding monitoring options and making it easier for people with diabetes to proactively manage their health."
Initial products to be developed under the agreement will focus on minimizing both the cost and size of CGM body worn components. The products will be designed to be disposable, and will be intended for use across all diabetes markets. The goal is to empower more people to control their diabetes with real-time and actionable information by developing a low-cost, small, bandage-sized sensor that is connected to the cloud. By addressing these needs, we believe we will have the platform that can replace finger sticks and become the standard of care."
---
Perhaps somebody should get on the phone and invite those Dexcom folks to the meeting?
|
|
|
|
Post by hammer on Dec 3, 2015 9:22:58 GMT -5
mnholden,
For the life of me I could never understand why SNY would not immediately start a trial utilizing CGM's comparing Novolog use with Afrezza use as superiority trial. It is a no brainer that Afrezza users would most likely show superiority since they actually can exploit real time CGM results.
Perhaps his meeting is the first step to future trials.
I would be very interested to ear if some of the scientific types at the meeting are from Google.
|
|
|
|
Post by factspls88 on Dec 3, 2015 9:24:35 GMT -5
Great connection mn. Perhaps the early adopters will be discussing their experiences with a joint team comprised of management from Mannkind, Sanofi, Dexcom and Google. It seems to me that the Google/Dexcom JV is sub-optimal without Afrezza since no other product on the market works as well. For those who might argue the insulin pump would suffice - it doesn't because the goal is to make instrusion into and onto the human body obsolete or at least minimal. It also doesn't take into account T2's, the largest market segment targeted by Afrezza. Importantly, an association with Google would validate and position Afrezza as on the forefront of diabetes managment.
|
|
|
|
Post by od on Dec 3, 2015 9:31:21 GMT -5
The meeting in San Diego sounds like pharmaceutical commercialization SOP, much of which would have been accomplished pre-launch had SNY developed Afrezza. Why should anyone expect an announcement?
|
|
|
|
Post by kball on Dec 3, 2015 9:33:28 GMT -5
DBC, I reached out to one of the well know early adopters, not Finta though, and he told me he is heading out for San Diego on Friday and will be there for the weekend. He also mention that he could not comment on the gathering or give me any information as he is "under contract to keep it quiet for now", his words not mine. I was curious to know for how long he has been under this confidentiality contract so I sent him another email asking him about it. If he does answer I will let you know, but it would make sense, as someone postulated in this forum, that they have been providing Sanofi with data for a while and that is the reason why Sam has not updated his blog since July.... I had wondered what was up, or not. Of course whatever seems to make sense regarding MNKD and Afrezza always seems to have some twist worthy of Hitchcock or M. Night. And here is a post from october where i was hoping the reason Sam stopped was connected to Sanofi or mannkind rather than Sam losing interest or whatever... Oct 25, 2015 at 7:47am sportsrancho, EveningOfTheDay and 1 more like this. ReplyQuote Post by kball on Oct 25, 2015 at 7:47am SO almost another 3 weeks have gone by, anyone have info as to why Sam isn't publishing? Is it connected in some way to the silent period? Is it possible maybe he has been hired by either Mannkind or Sanofi making his neutrality an issue?
I'm puzzled...and i miss him(I dont really keep up with twitter btw) edit: So it looks like Sam became a US citizen this week. Congrats Sam... Talk about a year of change! For him and the many he's helping Read more: mnkd.proboards.com/thread/1801/tracking-afrezzausers-blog?page=11#ixzz3tGgaewe0 |
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Dec 3, 2015 9:49:11 GMT -5
mnholden, For the life of me I could never understand why SNY would not immediately start a trial utilizing CGM's comparing Novolog use with Afrezza use as superiority trial. It is a no brainer that Afrezza users would most likely show superiority since they actually can exploit real time CGM results. Perhaps his meeting is the first step to future trials. I would be very interested to ear if some of the scientific types at the meeting are from Google. I suggested that some time ago hammer and now with what appears to be UHC putting Afrezza on formulary, Sanfoi should get 1,000 type 1 patients covered by UHC (10 patients from each of the top 100 endos) and do a 6 month trial testing A1c every 6 weeks and when finished, let the data rip. The new Dex5 sensor sends data directly to a smartphone which can then go right up to Google cloud. Recent court ruling states that if drug company believes something to be true, they can say it. When finished, let Jay Stockton create billboard marketing collateral that can also be used for direct mail and doctor office leave behinds with 3-4 bullet points and of course, run it through their agency and regulatory. Afrezza is too good and the RAAs are old hat. MN - did you know three of Dexcom's top execs used to work for you know who at mini-med? Terrance Gregg - Executive Chairman retired as chairman of mini-med in 2002 Kevin Sayer - CEO & President was CFO at mini-med from 1994 - 2001 (when MDT bought them) Jacob Leach - SVP R&D held R&D positions at mini-med from 1996 to 2004 (his focus while there was glucose sensing systems) Remember, every successful startup survives several near death experiences before achieving success. In the early days, Dexcom had some significant technology challenges. Now, they are a key player in the space well positioned for the evolving healthcare economy and world of big data. Dexcom and Google will become tools for measurement. Afrezza becomes the tool for creating unsurpassed patient outcomes which is what payors will reimburse for. |
|
|
|
Post by rrtzmd on Dec 3, 2015 10:40:58 GMT -5
I don't agree with biotec that the unfounded cancer scare is likely the biggest roadblock, but I'm sure it plays a role. It certainly got raised as an issue with Exubera. If everyone in the medical community believed there was no possibility of a risk, MNKD would not have spent the significant resources on doing those trials specifically to prove it isn't a problem. Like it or not, the FDA has specified long term safety studies... those that are ultra cautious may well think it safest to wait until those are done. biotec may simply have a different risk profile than others here and thus, even if not believing this specific unfounded risk, believe the concern occurs more in others than we do. Personally, here is how I imagine it might be most harming Afrezza. You've got some overworked doc. He's heard about Afrezza but just to the extent it's non-inferior and doesn't require needle. He vaguely remembers something about safety concerns with Exubera... perhaps even mistakenly thinking that the concerns had to do with its withdrawal from the market. Says to himself... eh, doesn't seem compelling if it's just a patient convenience thing, maybe I'll wait for more safety data. "You've got some overworked doc." Most likely. As far as the rest, think more in terms of the doc having lispro/lantus protocols memorized inside/outside/and all around the town. He/she has honed their dosing skills to a fine enough edge so that if awakened at 3 am about some problem, little more than instinct is needed to give out instructions that at least won't kill whoever is on the other end before office hours. The doc can then roll over and go back to a peaceful sleep. Here comes the Sanofi rep touting afrezza. What? More rapidly absorbed? More rapidly eliminated? 4U, 8U, 12U cartridges? 4U for 1, 2, 3, or 4U of lispro? Get away from me already! |
|
|
|
Post by mnholdem on Dec 3, 2015 11:13:13 GMT -5
MN - did you know three of Dexcom's top execs used to work for you know who at mini-med? Terrance Gregg - Executive Chairman retired as chairman of mini-med in 2002 Kevin Sayer - CEO & President was CFO at mini-med from 1994 - 2001 (when MDT bought them) Jacob Leach - SVP R&D held R&D positions at mini-med from 1996 to 2004 (his focus while there was glucose sensing systems) I did not know that. It continually amazes me how many connections there are in the diabetes industry to Alfred Mann. 
I also wonder if Al is planning to attend this gathering of T1's in San Diego. That wouldn't surprise me, as he would probably like to personally thank those individuals who have been promoting Afrezza via the social network.
|
|
|
|
Post by dreamboatcruise on Dec 3, 2015 11:42:43 GMT -5
rrtzmd... thanks for the additional perspective. Therein lies part of the reasoning of why a partner with a seasoned diabetes sales and marketing team such as Sanofi was perceived as being beneficial, and now we know they will be spending the weekend in SD probably in part figuring out how best to get other doctors comfortable with introducing Afrezza into their practices.
|
|
|
|
Post by dreamboatcruise on Dec 3, 2015 11:55:28 GMT -5
Some more rabid "speculation" which is another word I hate now - almost as much as "hope"! The long term patient lung safety studies were baked in to the Sanofi-Mannkind partnership and might be considered an instrumental part in the future strategic planning for Afrezza. Sanofi knew it would have responsibility for the 5 yr, 8000+ patient lung safety studies (the most daunting PMR from the FDA) when it partnered with Mannkind. www.accessdata.fda.gov/scripts/cder/pmc/index.cfmThe first 2 Afrezza PMR studies (of 4) are complete and Sanofi is recruiting for the 3rd PMR (pediatric safety study). In addition to the results from the strictly controlled euglycemic clamp and PK/PD clinical studies, they need to understand absolute and temporal dosing requirements in real life use. They need to glean as much information as possible to understand the barriers to Rx. The best strategic minds had BETTER be at work in Sanofi's Clinical & Regulatory departments. I have to assume that Sanofi's Marketing, Clinical/Regulatory groups are: 1) following the experiences of more public early Afrezza adopters and Afrezza users in general, and MEETING with them in person to discuss. 2) laying out clinical protocol approaches to satisfy the lung safety PMR and incorporate the collection of 1-2 year superiority data on Afrezza. 3) holding advisory board meetings with opinion leader MD's, PhD researchers, and other experts to present early adopter results and to get feedback for the lung safety clinical trial protocols and other smaller cohort studies. It sure seems to me that Sanofi is not giving up on Afrezza. Fully agree with you regarding what I would expect Sanofi to be doing. Finally with this advisory board meeting we are perhaps getting some evidence that this can be moved from the realm of speculation and hope into the realm of a realistic expectation. I had expected it to occur sooner, but certainly willing to give the benefit of the doubt that they know better than I about how to accomplish what needs to be done. |
|
