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Post by mannmade on Jun 28, 2018 20:09:45 GMT -5
seekingalpha.com/news/3367072-liquidia-technologies-files-57_5m-ipo#email_linkLiquidia Technologies files for $57.5M IPO Jun. 28, 2018 9:03 PM ET|By: Jason Aycock, SA News Editor Biopharmaceutical firm Liquidia Technologies has filed for an initial public offering. It's looking for up to $57.5M, via Jefferies and Cowen. The company's looking to list on Nasdaq Capital Market under the symbol LQDA. For the three months ended March 31, revenues were $925,970 vs. a year-ago $1.639M. Operating loss swelled to $8.88M from $6.77M, and net loss was $27.5M vs. a year-ago $9.84M. Potential competitors, particularly considering the area of pulmonary arterial hypertension, include Insmed (NASDAQ:INSM), MannKind (NASDAQ:MNKD), Durect (NASDAQ:DRRX), Innocoll, Heron Therapeutics (NASDAQ:HRTX), United Therapeutics (NASDAQ:UTHR), and Actelion (OTCPK:ALIOY)
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Post by mannmade on Jun 28, 2018 20:06:42 GMT -5
3. The 12% improvement in range in time is also very significant improvement. To bring that data point into context, Dr. Kendall noted that the 12% improvement in range in time with Afrezza is basically the same improvement that CGMs achieved when CGMs first got FDA approval. And Dr. Edelman is stating CMGs is now standard of care. I should just say here that there was a gap after FDA approval before insurers would cover CGMs. The first CGMs as we would recognize them were approved around 2005 (the Guardian RT CGM, and the Dexcom STS CGM System). It took another 4 years before an insurer would cover them, and took a major JDRF trial to force that. A CGM now gives around a 25% improvement. Guess mnkd is right on schedule...  |
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Post by mannmade on Jun 28, 2018 15:04:07 GMT -5
Goya, this is how I see a partnership with AFREZZA and CGM companies working. Kind of like selling cars. Dexcom rep goes in to sell benefits of cgm and TIR etc... and that all this will give patients better results with Hba1c.
Then they sell AFREZZA as an upgrade to cgm, similar to selling a higher performance engine.
This is a very synergistic sell and can be replicated with all cgm companies. Perhaps give a 25% discount on first year of any AFREZZA scripts sold with a cgm.
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Post by mannmade on Jun 26, 2018 20:20:26 GMT -5
I think we are kidding ourselves if we think this is about MNKD's stock visibility. At some level its a fool me once, fool me twice, fool me three times? We are not generating excitement this time. MNKD is very visible to the people in the know. I swear this is an insurance issue. Once the writers/physicians can write with out pre-authorizations or office phone calls from their insurers.... if they write, the patient laboratory results and patient happiness will keep them writing. The bump will come when we get increased insurance coverage, it seems to me united health is the nut to crack. Perhaps this too is an area where dr. Kendall expertise can help. Peppy I think you are spot on... the day's of speculation for mnkd are over... its about weekly scripts and revenue period. This is not to diminish what was a positive ADA. The real value of the ADA for mnkd will come (or in hindsight) be determined over the next 6 months as it is refelcted in increased insurance coverage, scripts and revenue... |
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ADA
Jun 26, 2018 13:43:26 GMT -5
Post by mannmade on Jun 26, 2018 13:43:26 GMT -5
Was being sacastic... as we are currently at $2. |
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ADA
Jun 26, 2018 12:56:45 GMT -5
Post by mannmade on Jun 26, 2018 12:56:45 GMT -5
The price target did move as I recall didn't Wainwirght lower the target to $2 very recently?
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Post by mannmade on Jun 25, 2018 20:15:34 GMT -5
They should add this to the Afrezza Pediatrics Trial... medicalxpress.com/news/2018-06-diabetes-medications-dont-youth.htmlTwo diabetes medications don't slow progression of type 2 diabetes in youth June 25, 2018, National Institute of Diabetes and Digestive and Kidney Diseases Two diabetes medications don't slow progression of type 2 diabetes in youth Dr. Kristen Nadeau, principal investigator of the Restoring Insulin Secretion (RISE) Pediatric Medication Study, discusses treatment with a RISE participant. Nadeau is a pediatric endocrinologist at the University of Colorado Anschutz …more In youth with impaired glucose tolerance or recent-onset type 2 diabetes, neither initial treatment with long-acting insulin followed by the drug metformin, nor metformin alone preserved the body's ability to make insulin, according to results published online June 25 in Diabetes Care. The publication is concurrent to a presentation of the results at the American Diabetes Association Scientific Sessions in Orlando, Florida. The results come from a study of 91 youth ages 10-19, part of the larger Restoring Insulin Secretion (RISE) study. To determine if early, aggressive treatment would improve outcomes, participants at four study sites were randomly assigned to one of two treatment groups. The first received three months of glargine—a long-acting insulin—followed by nine months of metformin. The second received only metformin for 12 months. Participants were then monitored for three more months after treatment ended. RISE was funded primarily by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health. The RISE Pediatric Medication Study found that beta cell function—key to the body's ability to make and release insulin—declined in both groups during treatment and worsened after treatment ended. An earlier NIH-funded study also found that type 2 diabetes progresses more rapidly in youth than previously reported in adults despite comparable treatment. "Only two drugs are currently approved for youth with type 2 diabetes, and we were disheartened to find that neither effectively slows disease progression," said Dr. Ellen Leschek, project scientist for the RISE Consortium and program director in NIDDK's Division of Diabetes, Endocrinology, and Metabolic Diseases. "Type 2 diabetes in youth has grown with the obesity epidemic, and we need treatments that work for kids. It's clear from this study and others that type 2 diabetes in youth is more aggressive than in adults." The results were published concurrently in Diabetes Care with two other manuscripts that compared participants of the pediatric trial with their adult counterparts in two other RISE trials. Using baseline assessments, RISE researchers found that the youth had more insulin resistance and other signs of disease progression than their adult counterparts at the same stage in the disease, results consistent with other earlier studies. As well, the pediatric group at baseline responded to the severe insulin resistance with a greater insulin response than adults, potentially a reason for the youth's more rapid loss of beta cell function. While the RISE pediatric group's treatments did not preserve or improve beta cell function, results showed modest improvement in blood glucose with metformin in both groups. "Metformin is still a useful method to lower the blood glucose levels of youth with type 2 diabetes, but metformin alone is not a long-term solution for many youth," said Dr. Kristen Nadeau, principal investigator of the RISE Pediatric Medication Study and professor of pediatric endocrinology at the University of Colorado, Anschutz Medical Campus. "As RISE shows, there is an urgent and growing need for more research to find options to adequately slow or prevent progression of type 2 diabetes in youth." The longer a person has type 2 diabetes, the greater the likelihood of developing complications including heart, kidney, eye, and nerve diseases, making it critical for young people with type 2 diabetes to quickly achieve and sustain control of their blood glucose. However, because type 2 diabetes has historically been an adult condition, information about how to effectively treat youth is limited, and pediatric diabetes experts have had to rely on best practices for adult treatment—an imperfect translation given the differences in physiology between the groups. "Our understanding of how type 2 diabetes affects youth is still maturing, and we must continue to explore treatments to ensure that these young people can live long, healthy lives," said NIDDK Director Dr. Griffin P. Rodgers. "These results give us another piece of the puzzle to find which therapies will treat youth with type 2 diabetes." The RISE Consortium comprises three trials, all using similar assessments to measure results, to be compared with one another when all trials of the study are completed. The goal of RISE is to find ways to reverse or slow the loss of insulin production and insulin release, so people at risk for type 2 diabetes or recently diagnosed with the disease can stay healthier longer. |
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Post by mannmade on Jun 24, 2018 18:54:09 GMT -5
As an aside to the post drectly above, I spoke with a UCLA endo several times two years ago to intorduce him to Afrezza and explain to him about how it works to be able to let pwd spend more time in range with lower fasing BG levels and acheive lower Hba1c's some in non-diabetic range. He told me quote: "I don't beleive you and you must be lying to me." Now this was not a personal attack on me he just did not trust what i was saying to him at the time. This is where Dr. K should make a big difference with the stat study in hand. Interesting, this 1.2 point change in HbA1c was a one month change. Excellent point as we all have seen the longer Afrezza is used the better patients understand it and for most their Hba1c seems to get better as well... |
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Post by mannmade on Jun 24, 2018 18:45:04 GMT -5
Thank you Goyo. Me too, as I have been having a hard time trying to wrap my arms around what I thought was the initial luke warm reaction to the stat study as i posted under the Dr. K effect thread earlier today. It will take time but I genuinely believe mnkd is finally on the right path with the right story and the right story teller.. GLTAL's...
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Post by mannmade on Jun 24, 2018 18:38:54 GMT -5
As an aside to the post drectly above, I spoke with a UCLA endo several times two years ago to intorduce him to Afrezza and explain to him about how it works to be able to let pwd spend more time in range with lower fasing BG levels and acheive lower Hba1c's some in non-diabetic range. He told me quote: "I don't beleive you and you must be lying to me." Now this was not a personal attack on me he just did not trust what i was saying to him at the time. This is where Dr. K should make a big difference with the stat study in hand.
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Post by mannmade on Jun 24, 2018 18:35:05 GMT -5
Peppy help me out here... Thought I recalled seeing this published a month or two ago... Perhaps I misunderstood? published in the 2018 Standards of care. it may be the supplemental. I may be able to dig it up easily. Recommendations - A reasonable A1C goal for many nonpregnant adults is ,7% (53 mmol/mol). A - Providers might reasonably suggest more stringent A1C goals (such as ,6.5% [48 mmol/mol]) for se- lected individual patients if this can be achieved without significant hypoglycemia or other adverse ef- fects of treatment (i.e., polyphar- macy). Appropriate patients might include those with short duration of diabetes, type 2 diabetes treated with lifestyle or metformin only, long life expectancy, or no signifi- cant cardiovascular disease. C - Less stringent A1C goals (such as ,8% [64 mmol/mol]) may be ap- propriate for patients with a history of severe hypoglycemia, limited life expectancy, advanced microvascu- lar or macrovascular complications, extensive comorbid conditions, or long-standing diabetes in whom the goal is difficult to achieve de- spite diabetes self-management education, appropriate glucose monitoring, and effective doses of multiple glucose-lowering agents including insulin. B Read more: mnkd.proboards.com/thread/10068/ada-2018-standards-care#ixzz5JOA8OzbOThank you for coming to my rescue Peppy! You are the best... And this makes the whole stat study more relevant than ever for the ADA and PWD... Taking the officlal hba1c recommended measure from 8.0 to 6.5 would be HUGE imho... And not one other product will be able to do this without severe hypos which is ironically the reason most endos don't think Afrezza can either. |
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Post by mannmade on Jun 24, 2018 18:28:18 GMT -5
The calculator on the right @ the link Peppy help me out here... Thought I recalled seeing this published a month or two ago... Perhaps I misunderstood? |
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Post by mannmade on Jun 24, 2018 18:25:02 GMT -5
Likely part of a coming pump and dump? So probably not matter too much where it airs for now imho until they do a real marketing and media push with a new creative designed to drive product sales. You think so, all part of the 'tea leaves' signaling the pump and dump and dilution? Investor conference, ADA...when was the last analyst upgrade? That's a sure signal when we start seeing analyst upgrades in the next week. TV ads? Not sure that's part of the leaves? What else. What I am saying is that most of us, knowing mnkd needs to raise money soon, and knowing that they are having a financial investor conference on Wendesday, may be running the old commercials as one part of the current short term strategy to promote mnkd to investors prior to the money raise. They don't have the money to run a national campaign nor even a wide spread regional or multi-market local campaign. However, by running select local spots in advance of the investor meeting they can tell potential investors at the meeting that they have started media in the local area markets that are quote "promotionally sensitive." Otherwise why run the old commercials before they have a real budget set aside for marketing with a new commercial that can speak to Dr.K's message. Especially with a brand new head of marketing who will likely want to change the creative. I don't think it is for the ADA, otherwise I would just run it in micro nets at the ADA and the hotels etc in the area. Many companies run commercials for investor only reasons just prior to raising money or to boost stock price. I may be wrong but imho I really see no other reason to be running a commercial right now. |
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Post by mannmade on Jun 24, 2018 18:01:58 GMT -5
My "take"on the stat study has been determined in part on the actual results, which by and large seem actually pretty good, but also on what I consider to be the promise of what it has shown us and for which Dr. K is integral in the storytelling and explanation both because he "sees" it and because he has the gravitas to tell it/sell it to other experts in diabetes.
When the stat study first came out I was expecting more positive comments from people. I am not a true science person so I was a bit confused at what I thought was the underwhelming response to the study, espcially given a few people on this board whom I respect for their science background that did not see the merits as very positive..
But upon further study and hearing more comments it is now my personal beleif that the stat study results are quite positive and lay the groundwork for the new mannkind and the new conversation about Afrezza that goes with it. That conversation imho is as follows:
1. Stat study showed how Afrezza can accomplish exactly, if not better control, as what an RAA can accomplish in less time with less hypos. To me, this in and of itself is good news. You can debate whether or not the numbers are statiscally relevant. Does it make Afrezza superior? I beleive it does.
2. Now the promise... what the study did not do is show how Afrezza can work to keep better control and TIR at significanntly lower levels of fasting BG which would require in many cases higher does of basal insulin and/or adjusments to prandial dosing. But as we know from the many anecdotal posters on social media, they are getting non diabetic numbers in the 5's and even more of them in the low to mid 6's for Hba1c's using Afrezza by targeting lower fasting BG at anywhere from 120 to 140.
So why didn't the stat study show this as a goal? because imho it could not as a first of its kind study with a comparison to RAA's as its basis, since doing so would require dosing that most docs will not do with traditional RAA insulins as it would drive pwd into more severe hypos. (The stat study targeted 160 for fasting BG.) A separate study targeting lower BG will likely have to be done under more direct management if a comparison is done or with Afrezza only.
THIS is the NEW story that could not be told now without the stat study... Remember that the ADA recently raised the acceptable Hba1c level to 8 from 7 or so because it has been too hard to get pwd to the lower levels without hypos and compliance is difficult with all that it entails for a T1. Afrezza changes all of this. Just think if you can now get pwd to a range of 5.5 to 6.5 with the same or less hypos... You don't think this would have to be the new SOC?
And this is what Dr. likely meant when stating that Afrezza should be the SOC.
Now again I do not have diabetes and I am not a science person so someone with a better understanding may be able to correct me if I have mispoken and hope they will but what imho I beleive is the true value of the stat study is the conversation Dr. K and the reps can now have with other docs that they had no basis for prior to the stat study...
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Post by mannmade on Jun 24, 2018 17:28:23 GMT -5
A 1% reduction in something doesn't sound that important. Since a1c is a percentage, going from 8 to 7 is presented as a 1% reduction. Couldn't it somehow be called a 12% reduction because 8x.88=7. If you then consider that an a1c of 5 is perfect, going from 3 points above perfect to 2 points above perfect is a 33% reduction. Obviously endos and t1ds know what a1c means, but most financial analysts and investors dont. Would it help to present the results differently? Or is this the dummest thing I ever posted here? What financial analysts know is no one has every had a treatment which can reduce A1c from 8 to 7 with no additional hypos and its easier to use.
All these analysts need to know is one phrase concerning afrezza "game changer" - which translates into "buy buy buy".
SayHey could not agree with you more. Especially as it is my undestanding the ADA just raised the acceptable number for Hba1c to 8 as it was too hard to get most diabetics to 7, if I understand this correctly. |
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