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A rock...
Aug 30, 2016 17:06:10 GMT -5
via mobile
Post by mannmade on Aug 30, 2016 17:06:10 GMT -5
I believe Matt P''s exact words were, as I recall, mnkd will have enough money to take us into 1st Q 17. I do not remember him being more specific such as end of the Q.
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Post by mannmade on Aug 30, 2016 0:20:33 GMT -5
Study finds tight glycemic control provides no impact on patient-important microvascular outcomes Published on August 29, 2016 at 3:41 PM · No Comments
inShare 5 The glucocentric focus on lowering blood sugar in Type 2 diabetes may have short-circuited development of new diabetes therapies, according to a new paper published by Mayo Clinic researchers in the journal Circulation: Cardiovascular Quality and Outcomes.
The authors, Victor Montori, M.D., and Rene Rodriguez-Gutierrez, M.D., of the Knowledge and Evaluation Research Unit at Mayo Clinic, systematically examined journal articles and clinical practice diabetes guidelines published in the last decade (2006 and 2015) for statements related to value of tight glycemic control in the prevention of chronic diabetic complications. The authors then compared them with the body of evidence accrued in the past two decades regarding the effect of tight glycemic control on patient-important micro- and macrovascular outcomes.
The study, funded by Mayo Clinic's Clinical and Translational Science Award, found that tight glycemic control (maintenance of a hemoglobin A1c value lower than 7 percent) had no statistically significant impact on patient-important microvascular outcomes (end-stage renal disease/dialysis, renal death, blindness and clinical neuropathy). In contrast, all practice guidelines and a majority of published statements (around 80 percent) support tight glycemic control to prevent those complications.
Related Stories Hydrothermal DMR results show promise in treatment of type 2 diabetes Prevalence of coronary calcification similar between patients with psoriasis and type 2 diabetes Detecting diabetes’ deadly ketones For patient-important macrovascular (cardiovascular) complications, the evidence shows that tight glycemic control reduces the risk of nonfatal heart attack by around 15 percent, but has no impact in all-cause mortality and cardiovascular mortality. Also, the risk of stroke did not seem to be lowered by tight glycemic control and the effect on amputation was imprecise. During the studied time period, statements about tight glycemic control to prevent these complications shifted from largely supportive (85 percent) to skeptical (20-30 percent) after the publication of a single study (the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial) in 2008 that is not consistent with the results of other studies (body of evidence).
Overall, the authors suggest that the widespread consensus for tight glycemic control should be re-examined.
Drs. Rodriguez-Gutierrez and Montori write that they hope this paper will spur research into new therapeutic approaches to prevent diabetes complications. They write, "Consider the list of evidence-based therapies recommended … to prevent retinopathy or neuropathy beyond glycemic control: none."
Instead of focusing on tight glycemic control, the authors suggest glycemic moderation may help advance the individualization of diabetes care, using shared decision making to select glycemic targets and treatments.
The authors point out that patients with Type 2 diabetes seem to live longer and with fewer complications, at least in some parts of the world, and suggest a careful and thoughtful recalibration of treatment could promote patient trust and provide new answers to this pandemic problem.
Source: Mayo Clinic
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Post by mannmade on Aug 29, 2016 17:28:26 GMT -5
As I mentioned in my post entitled "Is this the Shorts Last Hurrah?" We currently seem to be seeing what I hope is the short's final assault with support from their reserves/underlings...
Editor's Picks
MannKind: The Curtain Has Been Drawn And The Microphone Is In Place! Aug. 29, 2016 3:04 PM ET|57 comments | About: MannKind Corporation (MNKD), Includes: SNY Looking For Diogenes Looking For DiogenesFollow(525 followers) Biotech, mid-cap, research analyst, dividend investing Send Message Summary
I will update the current issues facing MannKind.
I will address the ever changing story line being shared with investors.
I have provided a direct comparison for Sanofi's vs. MannKind's marketing efforts with Afrezza.
The Curtain Has Been Closed and the Microphone is Ready for The Fat Lady Singing the Dirge!
The Flip of all Flops!
Long before MannKind (NASDAQ:MNKD) obtained FDA approval for Afrezza in 2014, they already knew there would be the issue of third party payor willingness for giving them the needed tier assignment that would negate the out-of-pocket expense for the patients. If one read their public documents, for years they mentioned they were working on the issue and that insurance companies were showing their willingness to give them the coverage they needed to resolve this issue. MannKind knew this problem existed because Pfizer (NYSE:PFE) had experienced, with Exubera, the same issue of insurance companies refusing to cover their product. Not only in the US, but in EU countries where they refused to provide reimbursed at any level for Exubera.
With patient insurance coverage being critical, and with the long-term assurances that MannKind and Sanofi (NYSE:SNY) were on top of the situation, where does this issue stand after the FDA approved Afrezza more than two years ago? For the answer, we can see MannKind's CEO being quoted in the August issue of the Santa Clarita Valley Business Journal (By using the following link, click on the August edition, scroll to Page19-Section Titled-Overcoming Problems):
"Another issue is that most health insurers in the United States have Afrezza in a Tier 3 reimbursement category. That generally means that co-payments are higher than with other medications. There is no disadvantage to the patient being in Tier 3, he says."
For approximately 4 years the management of MannKind told investors that it was important that they obtain the more lucrative tier placement for Afrezza. Now in August, 2016, the CEO tells you that what they had been saying and doing for all these years was no longer an issue, and obviously wouldn't impact their goal of making Afrezza a booming success story.
Truly amazing flip-flop on this issue, especially when you consider the same CEO has changed his story, apparently because he finally realizes that insurance companies have refused to give a better tier coverage for Afrezza. And you can take it to the bank, this issue is why MannKind and Sanofi made no effort to submit Afrezza for approval in the EU countries. So how can any investor get to the bottom of this issue--flipping from needing better insurance coverage to now suddenly having the CEO telling you there is no disadvantage to the patient for Afrezza being in Tier 3? For the answer to this nagging conundrum of first one answer and now spinning a story about there never being an issue, where can one find a definitive answer for this issue? Let's look at what the CEO has signed off on personally with the SEC filed 2015 Annual report that was issued only recently.
"In the United States and elsewhere, sales of prescription pharmaceuticals still depend in large part on the availability of coverage and adequate reimbursement to the consumer from third-party payors, such as government and private insurance plans. Third-party payors are increasingly challenging the prices charged for medical products and services. The market for AFREZZA and our product candidates for which we may receive regulatory approval will depend significantly on access to third-party payors' drug formularies, or lists of medications for which third-party payors provide coverage and reimbursement. Also, third-party payors may refuse to include a particular branded drug in their formularies or otherwise restrict patient access to a branded drug in their formularies or otherwise restrict patient access to a branded drug when a less costly generic equivalent or another alternative is available. --This process could delay the market acceptance of any product and could have a negative effect on our future revenues and operating results."
So let's get to the crux of what the CEO is telling you, if you would bother reading their legally binding SEC documents where they have to come clean with the reality of the situation:
"Patients will be unlikely to use our products unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our products."
Investors in MannKind's stock can't have it both ways! Either the August Santa Clarita Business Journal interview or the legally binding SEC annual report is truthful. But both of them can't be truthful because they are bifurcated by factual elements that are as wide and deep as the Pacific Ocean. And now, 82 weeks, and soon to be two years of marketing results, anyone with a degree of effort and looking at the ability for MannKind retaining a patient once they have been prescribed Afrezza, they know which one is the TRUTH.
Where We Stand as We Enter Month Nine of MannKind's Control of Their Destiny:
The ball is totally in MannKind's court and they can't put the ball through the net! It has been my contention the best way to compare their results against what Sanofi was able to achieve, is by comparing the results that followed the respective ADA conference in 2015, and now, 2016. In 2015, Sanofi had the opportunity for marketing exposure with the key medical professionals that could go back and prescribe Afrezza to their patients. The same things apply for 2016, where it was MannKind marketing effort that had center stage with the same medical professionals. In reality, the opportunities were not the same, because in 2015, Sanofi was starting from ground zero-no prior knowledge for the attending medical professionals. Also, Sanofi didn't have the benefit of introducing the doctors to any new clinical data, whereas, MannKind had several sessions where the much ballyhooed new data was on display. How soon those touting the stock seem to forget that it was this new clinical data that was going to make the difference. Only now they are reverting back to their long term didactic need for just needing more time to train the doctors!
We will soon be entering the ninth month that MannKind knew they would be taking over the marketing of Afrezza. We also know that during the Sanofi reign they had brought on at least a few prescribing physicians. Must I remind MannKind investors that the clamor has been about the decline in new prescriptions in 2016 was supposedly due to uncertainty about the availability of Afrezza. So logic would have been for going back to these friendly initial doctors prescribing Afrezza and give them the assurance that the product would be available. A simple letter, envelope and a $0.46 stamp-Marketing 101. Considering that MannKind is a sinking ship with limited funds, one would hope that a least they would attempt to maintain the few doctors that had previously prescribed Afrezza.
It's All in the Numbers:
So with the discernible advantage that MannKind had as their starting point, let's look at the comparable results where we can compare MannKind against Sanofi's efforts.
ADA Conference: 2015 (6/5/2015)
ADA Conference: 2016 (6/10/2016)
NRx
Refills
TRx
NRx
Refills
TRx
Week 1
316
118
434
93
164
257
Week 2
330
93
423
88
162
250
Week 3
386
130
516
107
159
266
Week 4
329
136
465
84
132
216
Week 5
364
111
475
99
136
235
Week 6
339
148
487
115
171
286
Week 7
319
166
485
116
152
268
Week 8
329
154
483
117
159
276
Week 9
315
139
454
135
120
255
Week 10
273
184
457
124
128
253
The first things one can note are the NRxs results from 2015, when compared to 2016. Again! Simple logic would have been for MannKind making contact with the previous prescribers--unless they knew that going back to them would be a futile effort due to their current opinion about Afrezza. The reality being, if they have been calling on these prior prescribers, the results have been a disaster. Looking back to the 2015 ADA and the ensuing ten weeks we saw 3300 new prescriptions having been issued. However, looking at the comparable results for MannKind's efforts in 2016, we see a meager 1078 new prescriptions being written. This translates to an enormous 67.7% drop achieved by MannKind's sales team. Based on 65 sales representative, this reveals that on average each representative has sold 16.5 new prescriptions over the last 10 weeks. Breaking it down further, based on ten weeks of marketing, each sales team member sold 1.65 new prescriptions per week. However, the most revealing number is the Week 10, 2015 refill number (184) when compared to Week 10, 2016(184), we see that refills have dropped by 30%. Based on total new prescriptions written for more than 80 weeks, instead of refills on a weekly basis being in the thousands, we see miserable refill data continuing their precipitous drop. So just how long does one think a sales team can be paid when they are generating on average a meager 1.65 new weekly prescriptions?
I'm sure those touting MannKind's stock will ignore the prescription numbers and the reality. It was last year where they contended that prescription numbers didn't count, until they switched the story where it was simply Sanofi's fault in the results being achieved. So why wouldn't the same blame apply to MannKind where it's obvious their efforts have been abysmal. Remember, the excuse was doctors not knowing that Afrezza would remain available, so why has the sales team, in what has been more than two months, not stemmed the decline in refills? In just the interim nine weeks since the 2016 ADA, MannKind efforts has generated another decline of 25% in refills. So back to my beginning point about the CEO telling investors that better tier coverage by insurers didn't present a problem with their marketing efforts for Afrezza.
The Ongoing Need for New Operating Funds:
Who would want to invest their money in a company where the CEO doesn't understand the implications for how their product is going to be funded. If you don't think this was a known issue, then why did the same group of executive's dump $21 million dollars of their stock when it was trading above $8.00 a share.
In November, 2015, desperate for money, MannKind forced on Israeli investors a stock offering where they refused to accept the original number of shares being offered. The end result was MannKind diluted shareholder's value by 13,852,430 shares at $2.62 per share. Then only a few months later, May, 2016, MannKind once again needing operating funds, they diluted shareholder's value by another 30% where they sold 48,543,692 shares at $1.03 per share. The desperation only grows; in the last two offerings the new shares had been reduced from $2.61 to $1.03, a staggering 60% discount in per share valuation. With the closing share price of August 26, we see the stock trading at $0.79 per share, so guess what size the next dilution will required, while sales efforts are bringing in 1.6 new prescriptions by each sales team member, per week.
The Elephant in the Room:
When the Sanofi deal was first announced, I attempted to warn investors that the details of this arrangement had hidden items of concern. This was validated when MannKind announced that all upfront and milestone payments would be carried on their books as a liability. Plus, never forget that MannKind keeps dangling the "potential" of them borrowing more money from the Mann loan agreement. However, when one bothers reading the fine print related to the details, they keep using the word, MAY, when they reference other sources of operating funds. The following is taken directly from the SEC filed documents:
"Additional funding sources that are, or in certain circumstances MAY be, available to the Company, including approximately $30.1 million principal amount of available borrowings under the Mann Group Loan Arrangement."
Notice the key words---"may be"!
Investors need to understand, with companies like MannKind, where even the CFO told you very clearly that it was awkward for him talking about the Sanofi deal due to his lack of understanding the details, you had better read the nuances of their full SEC filed documentation. If you had done so, in the case of the "may be" limitation on them borrowing more from the Mann Group Loan Arrangement, you would understand why they haven't drawn down any of these potential funds since the Sanofi deal was announced. A simple read of the "full-details", you would know why you are seeing the desperate massive dilutions with selling more stock being the solution for their dire cash position.
After reading the above "may be" clause, now read the details of the overriding Sanofi Loan Facility where Sanofi holds first rights to the major hard assets of MannKind. There you will find the following iron-clad provision that Sanofi holds over the head of MannKind's management and their funding efforts. And you can't say that I didn't warn you about these issues!
"The Sanofi Loan facility includes customary representations, warranties and covenants by the Company, including restrictions on its ability to incur additional indebtedness, grants certain liens and make certain changes to its organizational documents."
In simple laymen terms, Sanofi prevents MannKind from incurring any additional indebtedness as they further restrict them from issuing liens required from any potential lender-including the Mann Group Loan Arrangement. This is why the only recourse is for MannKind generating operating funds is by issuing more and more stock. So with the stock trading at the current level, and what the previous price was where they got enough month to last one quarter, ask yourself how many shares they will have to issue now to get the same level of funding. Only now, maybe you will understand why the stock is trading at $0.79 a share, and will be soon going lower.
It is my sincere hope and wish that Afrezza remains available for those patients that need options for treating their medical condition.
Good luck with your future investing decisions!
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.
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Post by mannmade on Aug 29, 2016 17:25:10 GMT -5
He can't win... and neither can we... Hang in there goyo...
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Post by mannmade on Aug 29, 2016 17:18:28 GMT -5
I think you can look up how much he owns and as I recall it is a sizable number...
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Post by mannmade on Aug 29, 2016 17:01:03 GMT -5
I do not know, but someone on the board just posted in another thread it was part of the shares issues/approved at last BOD meeting for ee's
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Post by mannmade on Aug 29, 2016 16:51:29 GMT -5
garret nothing I know first hand, but consider that Matt might have a significant amount of shares acquired from options he exercised at $6 or $7 or more and paid taxes on them at the time they were exercised. He would be quite underwater now with hard dollars. And unlike Diane Palumbno, "the current smartest mnkd investor to date, imho," Matt to his credit has never sold what I would consider a significant amount of his shares. That's what I give him credit for. Mike's purchases are icing on the cake at the moment...
Also he has kids, and I know how much mine cost these days especially for private school, don't know if his are in public or private. And who knows maybe he supports a relative or two as I have had to do... Really with all due respect his issues and decisions are none of our business. He makes the occasional buy lately and I am happy for that. I am more happy with the plan they have laid out even if not progressing at the speed we would like. No judgement on you or anyone else, but I think we need to look at all sides and so ... Just say'in...
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Post by mannmade on Aug 29, 2016 16:37:40 GMT -5
60 or so reps and 10 NP's for direct support to docs and patients.
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Post by mannmade on Aug 29, 2016 16:29:10 GMT -5
Appreciate the kind words mnkdIs... Am very frustrated like everyone else with the current situation, you would have to be crazy not too being in Mnkd (for me since 2009), but I never give up when I believe in something... I also truly believe we will ultimately prevail, not on hope but on the fact that I believe Al was right about everything that AFREZZA can be and it's real world benefits... Not to sound too melodramatic but history will be the judge for us and there is a lot of history to reflect on in the thousands of posts on this board when the time comes... One way or the other... GLTA!!
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Post by mannmade on Aug 29, 2016 10:14:15 GMT -5
Reminds me of the Titanic... Just Kidding!!!! But thought I would post before someone else did who mighty actually mean it...
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Post by mannmade on Aug 28, 2016 18:36:14 GMT -5
I think IM_TypeOne is on to something...
How about calling the quick reaction time of AFREZZA the "Bolt" phase, fastest way of lowering BG to normal zone. As in I am bolting or I need to bolt?
And to catch up from behind, bringing BG up to normal zones, we call it the Phelps?
I mean AFREZZA is world class and in a class by itself...
btw, as I do not have diabetes, I just want to say in advance I mean no offense to PWD as I cannot pretend to know what you go through on a daily basis. Just looking for ways to keep spreading the word(s) about AFREZZA...
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Post by mannmade on Aug 28, 2016 14:10:19 GMT -5
This post is meant to be a bit Tongue in Cheek but nonetheless designed to make a point... before we had mobile phones who had heard of the following: Text message, SMS, emoji, etc...? And certainly not everyone had a mobile phone for many of the early years whether because people saw no need, too expensive, other available options, or not techno savvy... Basically the mobile phone ushered a new paradigm into the telecom/communication sector. Anyone old enough to remember having a phone bill from Pac Bell, GTE or Qwest for that matter... Let alone have both a separate local and long distance bill from Pac Bell/ATT? (Billing statements reflect my growing up on the left coast) Anyone remember when Bell Labs was the state of the art in tech development companies? Now ask yourself about the current state of pharma and diabetes in particular and make the analogy to telecommunications from 20 years ago... The newest therapy, TS/AFREZZA, "is the mobile phone," imho. And soon Sanofi will be Pharma's Bell Labs... So I thought I would have some fun with some of the new terms that we are beginning to see used as it gains more traction. Please feel free to add to the list and make some new ones if you like... GLTA! Real Time Diabetes Control, aka "RTDC" Sugar Surfing (my personal favorite) Time in Zone, "TIZ" Hit (a puff of AFREZZA), as in need a hit... The Outsulin Component
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Post by mannmade on Aug 28, 2016 13:19:06 GMT -5
This is a Sunday and MC is responding with answers to questions from the little people. When have any of MNKD stock holders been treated so well ? Any long on this board knows getting any news has been almost impossible. I would say this is "transparency". I would also say we have a man that is championing our mutual cause. I do not know all of his motives, but I am glad he is working for us. Many of us invested, more than we should have in this company, because we believed in Al Mann and Afrezza. I was taught that you do not invest in a person but the company's balance sheet. Now we seem again to have a person who has invested himself, as was Al Mann his whole life. Currently within MNKD, who has had the ability to give both hope to diabetics and the stock holders that need this company to be a success? We may not get the rewards we want but we have a person that has become the face of MNKD, Michael Castagna. Matt may not have been the dynamic leader we were looking for after Al left us, but Matt as the CFO and his knowledge has quietly done a great job in changing the direction of this company. I believe he is responsible for keeping the company, albeit battered, one with still a fighting chance for great success. Go MNKD Read more: mnkd.proboards.com/conversation/2850#ixzz4IeCWEmkNCould not have said any better... Ty
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Post by mannmade on Aug 28, 2016 13:13:00 GMT -5
"New therapies may dramatically improve quality of life, but those improvements won’t show up in an A1c value..." Wrong!, imho... Wow! I just read this article (ty, Sports for posting) and if the authors and diabetes community in general (I am not diabetic) knew more about what was going on with those using AFREZZA and a cgm most of this article and the conference would be about a whole new conversation called imho "The New Paradigm Shift in Treating Diabetes with Real Time Control." Or "How to Live with Non Diabetic Numbers as a Diabetic." And again imho, very ironically, Hba1c would become very relevant again for long term health and quality of life analysis before it's too late to do something about it, especially when combined with time in zone/range, "TIZ."
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Post by mannmade on Aug 27, 2016 1:49:00 GMT -5
I just could not help myself... I know this is for MannKind but... Karma!
Sanofi Just Can’t Catch a Break, Knocking at Major Support Again By Mayer Winkler August 26, 2016 8:20 am EDT
Print Email inShare 1 Investor sentiment surrounding French pharma giant Sanofi S.A. (NYSE: SNY) continues to sour after a string of disappointing news in recent months has brought its shares down below the key $39 handle for the ninth time this year. Major five-year support rests at $37 from way back in 2012, less than 4% away from where the stock is now. At this point, bad news is coming in consistently to the point that any significant piece of good news could catapult the stock higher, making Sanofi an interesting choice for dip-buyers.
The latest setback the company has had stems from a missed opportunity triggered back in 2015 that only now has come back to haunt it. Last year, Sanofi’s Auvi-Q, its own version of the popular EpiPen adrenaline shot by Mylan N.V. (NASDAQ: MYL), suffered a recall that ultimately led to the product being pulled from shelves and taken off the market completely early in 2016. Now it’s Mylan in the hot seat after being rebuked by Democratic presidential candidate Hillary Clinton for raising the price of its EpiPen.
Clinton, back in 2015, had rebuked the now infamous biotech executive Martin Shkreli for his own price rises while CEO of Turing Pharmaceuticals. This had catalyzed a broad decline for biotech stocks across the spectrum, and the same appears to be happening now.
In any case, Sanofi’s shelving of Auvi-Q was not earth-shattering, but the development is now coming back to bite them as Sanofi could have capitalized big with Auvi-Q on the political backlash that Mylan is now getting for raising the price of the EpiPen. Then again, had Auvi-Q remained on the market, the EpiPen price rise may never have happened in the first place.
Sponsored by Yahoo The 2016 New Sedan Models Beyond losing the patent on its best-selling insulin glargine product Lantus, something that has been anticipated for years, Sanofi was further hammered earlier this week by the U.S. Food and Drug Administration’s delaying of priority review for its combination iGlarLixi drug, for which Sanofi spent $245 million on a priority voucher to get to market ahead of competitor Novo Nordisk A/S (NYSE: NVO). It now appears that that money has been wasted and Novo will beat Sanofi to the punch.
Pile on to that Sanofi’s colossal failure with Afrezza, an inhalable insulin product developed by Mannkind Corporation (NASDAQ: MNKD) but which drew little to no market demand. The licensing deal for that product was ended in January and the rights returned to Mannkind.
There may yet be one more blow to Sanofi from the direction of Novo Nordisk. On August 5, Novo announced that a small Phase 2a trial on 50 patients showed that its oral insulin formulation lowered fasting glucose levels similarly to Sanofi’s insulin glargine. If this can be replicated in a Phase 3 trial, there may be even more trouble for Sanofi’s Lantus than there already is.
Novo is not the only diabetes-focused company succeeding with an oral insulin formulation however. Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) also recently announced expanded Phase 2B data on 188 patients showing its own oral insulin formulation lowering blood sugar levels versus placebo. If either or both of these oral insulin formulations get to market, the prospects for Sanofi could dim even further.
Taken all together, with sentiment and news surrounding Sanofi being so negative in 2016 so far, it could be considered an accomplishment for the stock to have held at current support levels. Any positive development from any direction could send shares on a brief but strong bounce higher off support.
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