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Post by EveningOfTheDay on Dec 3, 2015 12:10:56 GMT -5
DBC, I received response to my second request from my acquaintance. He did not answer my question directly as to how long he has been sending data to Sanofi, possibly because that could be a breach of contract, but did say that the reason for not sending info to Sam is investor harassment, his accounts being hacked and what not. He said he was still talking one on one with anybody interested in Afrezza offering advice and know how, but this days he is avoiding the internet. He thought it was a shame to not be able to post online without being harassed, but he said he was sick of it.
Makes me wonder how many of the increasing amount of people posting about Afrezza are suffering similar experiences.
Anyway, not the answer we were probably expecting and definitely not a full explanation on why Sam is not posting any of the results, but it is what it is.
As to Dexcom being part of the conversation this weekend, I guess it is possible, but I would not put to much weight on it. In my opinion it is way to early for meaningful collaboration, even if a few months ago Dexcom did comment on the success patient were seeing when using their devices and Afrezza together. Will see.
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Post by compound26 on Dec 3, 2015 12:18:57 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.. Yes, Dr. Steven Edelman most likely is involved. Quoting from the original post, the initial adopters will meet scientists from SNY and UCSD. We know that Dr. Steven Edelman works at UCSD. 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 hammer on Dec 3, 2015 12:30:49 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. Two very interesting bits of information. Could this meeting be a prelude to a new advisory meeting with FDA for label change? Or just compiling data for research to justify marketing to FDA in what they believe is true as you suggest? |
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Post by bradleysbest on Dec 3, 2015 12:35:21 GMT -5
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Post by dreamboatcruise on Dec 3, 2015 13:52:35 GMT -5
Any hint from anyone regarding how many Afrezza users will be at the event?
I know this is probably getting deep into the realm of info that SNY would send a hit squad out if revealed.
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Post by mssciguy on Dec 3, 2015 14:01:31 GMT -5
Any hint from anyone regarding how many Afrezza users will be at the event? I know this is probably getting deep into the realm of info that SNY would send a hit squad out if revealed. Wouldn't it be nice if it were telecast live? I don't understand why SNY has to be so stealthy. Come on, FDA is not that strict. Other companies pump up drugs routinely and excessively |
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Post by EveningOfTheDay on Dec 3, 2015 14:51:18 GMT -5
Any hint from anyone regarding how many Afrezza users will be at the event? I know this is probably getting deep into the realm of info that SNY would send a hit squad out if revealed. I have no idea and I think nor does my contact, but it is relatively safe to assume Sanofi must have invited many of the early adopters, some know to us some not. I would be curious to know if only T1 were invited or also T2. Spiro only mentioned that he had known about this for a while, but he did not clarify if he was asked to attend. If it was only T1s, does that mean Sanofi will eventually do the same with a T2 group. In any case any little indication that things are moving forward, no matter how snail paced, is a positive for me. I have been forced to rethink my timeline, but others had pointed out that Mannkind would not see mush progress for the first two years, and that the time frame to look at for realistic positive results was more in the line of 3 to 5 years. I am completely fine with all that, once again my problem is that I never expected the shorts would be able to effectively push the sp so low, even though I've been following Joey's inverse head explanation for a while. Now I have to worry about how this affects Mannkind's ability to move forward and at what cost. To me those are the most relevant questions at the moment, and unfortunately none of us seems to have a clear answer for them. Unless he really has no clue, Matt really needs to come out and tell us how the company plans to move forward. I can not think of any competitive or otherwise reason not to do this and although I understand they are, very probably, working on it, it makes me very uneasy not to have any news whatsoever from the company regarding this two issues. |
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Post by kball on Dec 3, 2015 15:02:00 GMT -5
Evening--my first thought would be they don't want to tip their hand to Sanofi as to the options they are considering...especially if such info might lessen or possibly worsen their already weak negotiating position w Sanofi.
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Post by mnholdem on Dec 3, 2015 15:25:50 GMT -5
Remember how Shkreli got involved by interfering with the FDA, which led to the second CRL and another half $billion in development costs?
Perhaps Sanofi is prudent and keeps a lid on things because they know that not only shorting hedge fund managers but many direct pharmaceutical competitors would also try to interfere if they were to know Sanofi's game plan... |
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Post by mnkdnut on Dec 3, 2015 15:51:02 GMT -5
It would be great to find out if/that Matt B. from Australia was invited to attend the meeting. He's had such great insights into the whole dosing/timing issue in optimizing Afrezza's effectiveness. The user dosing guidelines he talked about developing from his own experience (when, how much, how often with respect to meal type) should be something SNY is championing with their clinical advisors - and now, alpha user advisors(?) The addition of the recent clamp study results should make for a great discussion on how to coach new users to get the best possible results with Afrezza. Exactly what they need to do before starting a landmark outcomes study.
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Post by stevil on Dec 3, 2015 15:57:37 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. I will dump what little remains of my cashback rewards on my credit cards into my fidelity account and scrape as much money as I can to put into MNKD if SNY affirms a strong commitment to them. SNY will dump obscene money into making sure Afrezza is successful if they choose to stick with it. SNY needs something big right now, and while I don't think they're quite desperate, they probably aren't far off. SNY needs something big to stay a market leader. |
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Post by EveningOfTheDay on Dec 3, 2015 16:32:18 GMT -5
Evening--my first thought would be they don't want to tip their hand to Sanofi as to the options they are considering...especially if such info might lessen or possibly worsen their already weak negotiating position w Sanofi. You are very possibly right, but it still seems to me that at this point the longer Mannkind takes to give us some guidance the longer everybody assumes the worst. I could be wrong, but in my opinion the possibility of Sanofi abandoning ship, which I intently refuse, and the possibility of a secondary offering, which looks more likely every day, are the two factors depressing the sp. Of course the low RX does not really help either, but even though we know expectations have not been meet so far, we do not know what the expected numbers looked like, so we have little to judge on that area. With aloha, |
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Post by EveningOfTheDay on Dec 3, 2015 16:40:40 GMT -5
Remember how Shkreli got involved by interfering with the FDA, which led to the second CRL and another half $billion in development costs?
Perhaps Sanofi is prudent and keeps a lid on things because they know that not only shorting hedge fund managers but many direct pharmaceutical competitors would also try to interfere if they were to know Sanofi's game plan... MN, I do not know if your comment was directed to me, but just in case. When I say I would like a bit more clarity I do not mean from Sanofi. It would be nice to know what they are planning, but I understand their concerns and why they do not feel compelled to share anything. On the other hand, I do feel like Mannkind could lift a huge weight from our shoulders by clarifying a bit more what their financial situation is, and how if any it is affecting future development of other TS apps. I feel the longer they go without saying anything the longer and more ingrained the perception that they are in serious trouble will dominate the events. Personally, I am now thinking 2 to 4 more years before we see MNKD really do well in our portfolios. My concern is how they are going to cope financially and what will need to be sacrifice if any. I am sure there is a plan, I just would like them to, at least, give us some pointers. |
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Post by suebeeee1 on Dec 3, 2015 16:41:27 GMT -5
This is all pretty incredible. SNY needs to clean up the dosing issues. After a few months experience, my guess is that the dosing will be different for everyone. As has been mentioned, some people seem to need more than was required by injection. We wouldn't know since my husband didn't used insulin prior to Afrezza. However, we did need to fool around with the dosing at first as his blood sugar levels did not respond as we originally hoped. The coach program gave us "permission" to start the dosing 15 minutes after starting a meal. After that, he even required less over the first 3 months. So my guess is that the dosing problems and timing may have something to do with some people requiring more. After they figure it out, they might need less.
Overall though, it seems more of an art than a science. While we were very comfortable with playing around with it until we got it right, I suspect some type 1s who are fearful could shy from that kind of uncertainty. If the SNY meeting with first users helps iron these issues out, it is all good!
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Post by suebeeee1 on Dec 3, 2015 16:55:23 GMT -5
Maybe after getting a sample, they find out their insurance company will not cover it. I think since Afrezza's awareness is minimal, a lot of times doctors gave the samples to existing Afrezza users, rather than to someone who has never tried afrezza. In those circumstances, samples do not necessarily lead to new users. See examples below. Also see examples here: Afrezza SouvenierAnd for people who tried Afrezza and loved Afrezza, but have to gave up Afrezza for cost or other reasons, see posts below: I tried Afrezza- but I don't use it now. Also see this message: So??? Do I understand this correctly? Afrezzauser received *5* Boxes of Afrezza from his endo is ONE week?  No wonder we are running through samples like water!!! |
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No wonder we are running through samples like water!!!