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Post by compound26 on Dec 10, 2015 13:49:34 GMT -5
I can't imagine they would have divulged any info to Afrezza users about a pending BO at a medical advisory board meeting. That doesn't make sense. I meant he might have signed an NDA. Yes, definitely. Last evening, Sam posted a tweet saying that if any PWD following him is interested in knowing how many Afrezza users (probably the ones Sam is aware of) are achieving non-diabetic numbers, he/she can send a private message to Sam. But today I noticed that Sam has removed this particular tweet. He is definitely keeping quite based on an NDA. |
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Post by compound26 on Dec 10, 2015 13:40:05 GMT -5
What is going on right now? a 10% swing in the past 20 min or so... Did news break or is this just part of their game? During the last several months, we are generally up on Thursdays (before the release of new scripts numbers) and then we are generally pushed down on Fridays and Mondays after the scripts numbers are released. Except for this week, we generally recover a bit on Tuesdays and Wednesdays.  By the way, I expect to see our TRx to be around 650-680 tomorrow (a 30-40% increase compared with last week). |
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Post by compound26 on Dec 10, 2015 13:23:35 GMT -5
Catalyst guesses please? TV starting in January for those of us who believe and value Saxcmann. So lets start there but thats not nearly enough imo I would expect the the scripts uptick to pick up some steam in the coming weeks and months. The DTC (the magazine ads and most recently the direct mailing in select areas) will have some positive impact. In the last conference call, Hakan says the DTC has raised awareness of Afrezza significantly. Mankind received a lot of emails and phone calls on those DTC ads. We have not see much upticks on scripts. But we all have heard reports on social media that many times the process (for PWDs to get an Afrezza prescription) takes 3/4/5 months to complete. |
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Post by compound26 on Dec 10, 2015 13:20:36 GMT -5
And we know 2 of the 12 Afrezza users that presented their situation to the advisory board! I guess at least three.  Sam, Eric and most likely this guy: |
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Post by compound26 on Dec 10, 2015 11:55:32 GMT -5
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Post by compound26 on Dec 10, 2015 9:56:21 GMT -5
Pretty realistic assessment of MNKD situation by Motley Fool contributor.
1. Afrezza sales are tankingAfrezza's sales are NOT tanking. That is a ridiculous claim and distortion of facts. By any means the scripts (the sales) are growing, even though not at a fast pace as we would want. Yes, the Mannkind quarterly shipments to Sanofi did not increase, but quarterly shipments are not sales of Afrezza. Mannkind's shipments to Sanofi are decided and influenced by a lot of things and sampling, inventory, and channel filling are a big percentage of the shipments in the initial quarters. Shipments are not sales. And Afrezza sales are NOT tanking. Afrezza sales are growing, month by month, as based on Symphony and IMS.
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Post by compound26 on Dec 9, 2015 18:49:28 GMT -5
Catalyst guesses please? TV starting in January for those of us who believe and value Saxcmann. So lets start there but thats not nearly enough imo Didn't you also mentioned that Saxcmann was saying there is $25 million milestone tied to the San Diego event? If so, that will beef up the balance sheet to some degree. I know Hakan mentioned the milestone was tied to some development efforts. But not sure what it is. Others have said that it was related to certification of Sanofi insulin. |
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Post by compound26 on Dec 9, 2015 16:55:59 GMT -5
update from the same member on tudiabetes.org: www.tudiabetes.org/forum/t/insurance-company-denied-afrezza/49313/3We have mentioned the hypos and can prove them on the download of the meter. We will pay out of pocket, and I know they have a $150 knocked off the script but is that a one time thing only? I also know their discount is in effect only until next year. We are not new at this and have been at this for ten years. We have successfully appealed for Apidra, had continual appeals for sufficient testing strips, appealed for Dexcom successfully twice (now she won't wear it). We have one more appeal after this one. Problem is the endo who prescribed the scripts seems to have a very busy practice. We have switched endos before who have refused to fight for adequate strips. I hope the endo will follow through with us to the end of the appeal process. Her receptionist told us we can't appeal as the insurance is demanding visual impairment as one of their grounds. Naturally the endo cannot lie. Hoping for the best, and it won't end here. We will appeal at a governmental or State Insurance Board, whatever we can think of we will do. Once Sanofi stops the discount this could get very expensive. She seems to be using quite a bit of Afrezza... the dosing is not equivalent. But, no, not going back to Novolog, Humalog or Apidra. Been there. Done that. There is no comparison.
www.tudiabetes.org/forum/t/insurance-company-denied-afrezza/49313/8There is a second appeal. We know from past experience that they often will deny the claim and even the first appeal Then you go back with documentation and we did get her Dexcom on the second appeal. We also got her Apidra approved I think on the first appeal. We have had to fight for adequate testing strips countless times. For the next year we are okay because, although expensive, we can cut back elsewhere. She just picked up her first month's script (and she may need more, I'm not sure yet). Sanofi takes $150 off each box I think. She got two boxes of the 8 unit cartridge and one box of the four unit cartridge for $350. I think it may be even less expensive at Costco or Sams; we used Rite Aid. After next year if they don't renew the discount, it would cost upwards of $700. I think she will need another box of the 4 units per month at least. Diabetics and their parents friends, in fact most people with health issues should start a movement, much like Act Up, to get their medical needs covered. We know the drill. I think we will win in the end on the second appeal. Or time to go job hunting for better insurance coverage. That's one way. |
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Post by compound26 on Dec 8, 2015 18:24:41 GMT -5
i dont do hope but i will act on actuals, so here are some actuals that will allow me to possibly take another position (long): anything specific that you would add? 1. Fix for the cash position. Maybe al brings the cash, maybe they do another round of loans, or maybe they land a deal. But mnkd needs plenty more cash and now (now being the next quarter or two). 2. Clarity on SNY. Are they sticking with afrezza? Who knows for sure but some signs that would help me include starting the lung trial, starting a label improvement trial, and/or when january comes maybe a word of confidence from sny. But proof in the form of financial committment like the long term trials would be helpful. And no, what sny has done so far prepping for trials is not a sign for me yet. Its not nearly enough. 3. Getting a classy and business savvy ceo in place. 4. Taking some action to fix the balance sheet but not so harsh as to wipe out existing shareholders. 5. If they could bolster their financial position, i would like to see mnkd dump sny and start this process over with a hungry and dedicated BP focusing a lot of resouces into afrezza. two or more to of these events and mnkd is a different company from what we have seen in 2015. Quarterly financials will be out in Feb. You may find that there is more cash on the books than some think and additional financing is not necessary until end of 2016. This would probably mean that whatever additional measures should be in the planning stage by summer 2016. That report is looking pivotal for establishing investor expectations - they might be able to rationally address this somewhat in the interim through an investor conference. The only other opportunities that I see to fix the financing/balance sheet situation are additional loans (not necessarily advisable), milestone payments, TS deal, or dilution (via buy-in, new offering, or whatever). I don't know how you can do this at present in a non-harsh way. Given what we know up to now, as of 31 December 2015, they will have around $35-40 million cash, $37.5 million ATM (if they have not used any since last conference call) and $30 million loan facility from Mann Group. Hope they can announce the receipt of a further $25 million millstone from Sanofi or a TS upfront fee before the next conference call. |
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Post by compound26 on Dec 8, 2015 14:34:07 GMT -5
Based on their outfit, sure not like they are in the northeast cost. Does fit the temperatures in California. |
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Post by compound26 on Dec 8, 2015 11:09:51 GMT -5
Real world results with Afrezza
This is a continuation of my girlfriends experience with Afrezza, from approval to script to now her first A1C reading of 7.4. She has been on treatment for two of the last three month and her last A1C reading before afrezza was 7.8. On average her A1C's have been 7.5 for the last several years.
In addition to changing to Afrezza she also switched to toujeo and completely dumped the pump. She absolutely loves not having to use the pump anymore. One common characteristic many have reported when making the switch to toujeo is that it takes 10-14 days for the treatment to really settle into a diabetics system. She was no exception and for about 12 days her numbers were all over the place with a few readings in the 300's and one in the 400's. Once she got through this transition period things settled down immensely and have only been better and better with time.
There is also a transition period with Afrezza that I have not heard many discuss. This information, I believe, is valuable for those just starting this treatment and is worth sharing. There is a learning curve that she went through not only in how to time treatment (this was the easy part) but also in the physical act of inhaling Afrezza. At first she did have a reflexive cough, aided with sips of water before and after inhaling (thanks Sam), which caused her to be timid at first when she inhaled. There were times initially where she would take a reading huff, and nothing would happen. No reduction in blood sugar. She does not use a CGM so it could have been that her BS was actively on the rise, but we think it has more to do with user experience. If you are afraid to inhale or don't insert the inhaler appropriately its possible (we believe) to ineffectively deliver afrezza to the lungs. Fast forward two months and it appears that afrezza is working faster for her and lowering her BS more than ever before.
She has learned HOW to huff and is now effectively delivering Afrezza to her lungs as designed. I have seen a few people report similar results "I huffed and nothing happened". In our opinion this is user error which can be corrected with time and experience.
As of today her blood sugar control just seems to get better and better. She has learned how to inhale, how to time her doses, toujeo is completely onboard, and it appears that A1c readings in the 6's are in her future. Her BS log she has used since starting afrezza calculates a reading of 6.9 but I have noticed many users report actual A1C's higher than the calculated A1C. Taken at absolute value an improvement of 0.4 since her last Endo appointment is exciting and encouraging and any improvement is an improvement in her health which in the end is the real goal. As a user she will absolutely refill her script due only to convenience and being able to dump the pump. She has been in meetings all morning and I have not gotten details from her discussion with her Endo this morning but I I will share those once she tells me what he said.
Wish her luck on continued improvement in her treatment and we will keep you posted when her next A1C is taken. Good luck and best health to all diabetics.
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Post by compound26 on Dec 8, 2015 9:09:17 GMT -5
update from the same member on tudiabetes.org: www.tudiabetes.org/forum/t/insurance-company-denied-afrezza/49313/3We have mentioned the hypos and can prove them on the download of the meter. We will pay out of pocket, and I know they have a $150 knocked off the script but is that a one time thing only? I also know their discount is in effect only until next year. We are not new at this and have been at this for ten years. We have successfully appealed for Apidra, had continual appeals for sufficient testing strips, appealed for Dexcom successfully twice (now she won't wear it). We have one more appeal after this one. Problem is the endo who prescribed the scripts seems to have a very busy practice. We have switched endos before who have refused to fight for adequate strips. I hope the endo will follow through with us to the end of the appeal process. Her receptionist told us we can't appeal as the insurance is demanding visual impairment as one of their grounds. Naturally the endo cannot lie. Hoping for the best, and it won't end here. We will appeal at a governmental or State Insurance Board, whatever we can think of we will do. Once Sanofi stops the discount this could get very expensive. She seems to be using quite a bit of Afrezza... the dosing is not equivalent. But, no, not going back to Novolog, Humalog or Apidra. Been there. Done that. There is no comparison
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Post by compound26 on Dec 8, 2015 0:02:21 GMT -5
Latest comment from tudiabetes.org: www.tudiabetes.org/forum/t/insurance-company-denied-afrezza/49313Finally found a doctor in New York to prescribe Afrezza for 18 year old daughter. She loves it. Her blood sugar was 312 after eating out in a restaurant. 4 unit dose of Afrezza brought her to 180 in half an hour 130 in an hour. Problem is OXFORD LIBERTY is denying her on the grounds that she would need to have significant visual impairment or other severe complication to be approved. They do not care if Afrezza can prevent complications. Has anyone successfully appealed denial of Afrezza and, if so, on what grounds. She has had about four instances of 20s and 30s on her meter in the past month while away at college, despite the fact we were running her blood sugar high. We want and need an insulin that is out of her system in an hour or an hour and a half. Judging by her results from the sample packets this insulin is fast, effective and A LOT SAFER. |
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Post by compound26 on Dec 7, 2015 23:54:57 GMT -5
Note that Sam (Sam on Tudiabetes.org, not Sam Finta) uses less than one box in one month (he says one box will last 1.5 months for him). That is atypical. Most Afrezza users use more than that. Sam Finta uses about two boxes a month and I think at some time Laureen indicated that she uses 9 boxes for three months. In another tweet she mentioned she got a refill for 90 days for 7 boxes. I would roughly estimate that generally a user will probably need two boxes of Afrezza per months. That would reasonable as a 90 cartridge only gives you one cartridge for each meal. Since you will naturally need additional units for snacks and follow-up doses, two boxes per month would seem to be the right (average) number. In that case, the average cost will be much higher (than $159 as indicated by Sam on Tudiabetes.org), if not covered by insurance. This is because the Sanofi savings card is limited to one box per prescription/refill. So if you need two boxes per month, without insurance, the cost will be $380+ (say if you get two boxes of 90 x 4Us at Costco without insurance) or somewhere around $400. Note that you do NOT need to be a member at Costco to purchase Rx products at their stores or via their online (mail order) pharmacy. The only issue with online (mail order) is if your Rx plan has a mandated mail order pharmacy. For those that do not have insurance, Costco and the Sanofi discount card is a great idea and even more important as we all wait for formulary coverage to improve. Compound, any chance you can put some type of streaming banner ad on your blog about the above?
scotta: I understand Costco's price of Afrezza to be lower than the other pharmacies, but only slightly. AS indicated by the following comparison: www.goodrx.com/afrezzaI will add a link on the blog to goodrx.com indicating it as a resource to compare the price of Afrezza. |
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Post by compound26 on Dec 7, 2015 22:38:44 GMT -5
www.google.com/trends/explore#q=afrezza&date=now%207-d&cmpt=q&tz=Etc%2FGMT%2B5If you rank the searches by City, you will find Philadelphia and Austin ranked No. 2 and 3, trailing slightly behind LA. Recall there were some news reports from the local TV stations in those two cities not long ago. So it appears the news report do have some impact. At least the reports caused some people to do a google search.
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Sam, Eric and most likely this guy:
