|
Post by lakers on Jan 3, 2016 23:37:02 GMT -5
Hard to tell from where I stand on whether Sanofi's strategy was or will be any good. All I can say is that both Mannkind and Sanofi itself wet rather wrong in terms of expectations. That is not a comforting thing when it is obvious they had years and years to think through some of the issues they are now facing. The one thing out of their control was the label and perhaps that is enough of a factor to skew everything else, but if that is the case the plan should include, before anything else, trials, gathering of data and anything and everything to get a change in label as quickly as possible. Perhaps that is what Sanofi is attempting to do, and perhaps they are trying to do this in the cheapest possible way for sound reasons, but I think the jury is still out on their performance as commercial partners. For the time being I remain unimpressed. IMHO, Sanofi underestimated what it took to place Afrezza on Tier 2. BP's exclusive deal w/ CVS caught them off guard. Others PBM would not cover Afrezza as Tier 2 at premium price w/o a vastly more superior label. Sanofi should have initiated the superiority and post marketing trials in late 2014. They burnt a lot of time. Had they done that, Afrezza would have had a good chance to get Tier 2 on some PBMs in 2016. They will likely start 6-mo superiority trial 1Q16 and EMA, ME MAA in parallel. It's better late than never. DeSisto will need to articulate the business model going forward at the 1/13/16 JPM Conf.
|
|
|
Post by lakers on Dec 31, 2015 17:22:26 GMT -5
MannKind distinguishes between the two ("pain" and "migraine") listing them separately on their website under Technosphere Capabilities, which indicates to me that these are two separate API. At previous conferences, management told us that pain and pulmonary hypertension were to be areas of medicine for their first two pipeline drugs. However, these were to be drugs that MannKind was planning to develop themselves. The point of my original post is that other branded drugs can also be developed into Technosphere versions if management were to take the initiative to go after those companies. TEVA Aims to be #1 in Migraine, Pain, good partner Read more: mnkd.proboards.com/thread/4147/teva-aims-migraine-pain-partner#ixzz3vwJlMiOKGSK is equally likely as well. GSK could extend to cover RA (Rheumatoid Arthritis), Flolan (antiemetic). There is good synergy between Mnkd+GSK, Mnkd+TEVA. The new CEO brings more gravity and experience to hammer out deals. TEVA could extend to cover MS. Could Teva partner w/Mnkd for expiring Copaxone MS BLockBuster? Hakan has publicly alluded to MS by targeting central nervous disorder in an interview. You can dig it up. Read more: mnkd.proboards.com/thread/3827/teva-partner-expiring-copaxone-blockbust#ixzz3vwMBhbejI'd imagine both TEVA and GSK want Mnkd's TS. I refrain from saying the not obvious ... Hakan said Mnkd at its core is a drug dev co. As such, Afrezza may potentially be spun off. The remaining co will focus on drug dev alone, not mfgr. With upcoming partnerships, BoD may potentially consider spinning off to increase SH value. Disclaimer: Anything said here is just an opinion. Don't base your investment decision on this. Do your own due diligence at your own risk.
|
|
|
Post by lakers on Dec 31, 2015 16:09:19 GMT -5
Potentially, there are three partnerships, sumatriptan (a known API for rapid FDA approval), CBD (longer FDA process), and 3-way w/ Torrey Pines (medium FDA process) which is far more superior than anything on the market. The later is effective after 2 mins, non-opioid, very hard to overdose, no drug resistant. all that matters to me is the $$$$ upfront in those partnerships to let Afrezza gain ground There could be more than one partnership for pain, migraine mgmt. There should be upfront licensing Not tied to profitability for immediate recognition, learning from Sanofi deal.
|
|
|
Post by lakers on Dec 31, 2015 15:32:55 GMT -5
Sumatriptan already available as a nasal spray. www.medscape.com/viewarticle/429671_4In 1996 and 1997 sumatriptan was approved for use by intranasal administration in North America and Europe. Sumatriptan nasal spray is rapidly effective with an onset of efficacy beginning as early as 15 min post-dose compared with placebo. The 5 mg, 10 mg and 20 mg doses of sumatriptan nasal spray have been assessed thoroughly in five randomized, double-blind clinical studies[31]. Across the studies, all three doses of sumatriptan nasal spray were significantly more effective than placebo, but a higher incidence of headache relief 2 h post-dose was reported with the 20 mg dose compared with either the 5mg or the 10 mg dose. For sumatriptan nasal spray 20 mg, 55- 64% of patients reported headache relief 2 h post-dose compared with 25-36% of placebo patients. Headache recurrence is reported in 30-40% of patients treated with sumatriptan nasal spray[31]. In a study in which patients used the same dose of sumatriptan nasal spray for up to three attacks, 67% of patients responded for two of three attacks, and 35% of patients responded for all three attacks[15,32]. Like sumatriptan injection and tablets, sumatriptan nasal spray is effective and well-tolerated with long-term use for up to a year[31]. Potentially, there are three partnerships, sumatriptan (a known API for rapid FDA approval), CBD (longer FDA process), and 3-way w/ Torrey Pines (medium FDA process) which is far more superior than anything on the market. The later is effective after 2 mins, non-opioid, very hard to overdose, no drug resistant, finished animal trial, ready for human trial. CBD Misconceptions Updated: August 2, 2015 It doesn’t get you high, but it’s causing quite a buzz among medical scientists and patients. The past year has seen a surge of interest in cannabidiol (CBD), a non-intoxicating cannabis compound with significant therapeutic properties. Numerous commercial start-ups and internet retailers have jumped on the CBD bandwagon, touting CBD derived from industrial hemp as the next big thing, a miracle oil that can shrink tumors, quell seizures, and ease chronic pain—without making people feel “stoned.” But along with a growing awareness of cannabidiol as a potential health aid there has been a proliferation of misconceptions about CBD. “CBD is medical. THC is recreational.” Project CBD receives many inquiries from around the world and oftentimes people say they are seeking “CBD, the medical part” of the plant, “not THC, the recreational part” that gets you high. Actually, THC, “The High Causer,” has awesome therapeutic properties. Scientists at the Scripps Research Center in San Diego reported that THC inhibits an enzyme implicated in the formation of beta-amyloid plaque, the hallmark of Alzheimer’s-related dementia. The federal government recognizes single-molecule THC (Marinol) as an anti-nausea compound and appetite booster, deeming it a Schedule III drug, a category reserved for medicinal substances with little abuse potential. But whole plant marijuana, the only natural source of THC, continues to be classified as a dangerous Schedule I drug with no medical value. “THC is the bad cannabinoid. CBD is the good cannabinoid.” The drug warrior’s strategic retreat: Give ground on CBD while continuing to demonize THC. Diehard marijuana prohibitionists are exploiting the good news about CBD to further stigmatize high-THC cannabis, casting tetrahydrocannabinol as the bad cannabinoid, whereas CBD is framed as the good cannabinoid. Why? Because CBD doesn’t make you high like THC does. Project CBD categorically rejects this moralistic, reefer madness dichotomy in favor of whole plant cannabis therapeutics. “CBD is most effective without THC.” THC and CBD are the power couple of cannabis compounds—they work best together. Scientific studies have established that CBD and THC interact synergistically to enhance each other’s therapeutic effects. British researchers have shown that CBD potentiates THC’s anti-inflammatory properties in an animal model of colitis. Scientists at the California Pacific Medical Center in San Francisco determined that a combination of CBD and THC has a more potent anti-tumoral effect than either compound alone when tested on brain cancer and breast cancer cell lines. And extensive clinical research has demonstrated that CBD combined with THC is more beneficial for neuropathic pain than either compound as a single molecule. “Single-molecule pharmaceuticals are superior to ‘crude’ whole plant medicinals.” According to the federal government, specific components of the marijuana plant (THC, CBD) have medical value, but the plant itself does not have medical value. Uncle Sam’s single-molecule blinders reflect a cultural and political bias that privileges Big Pharma products. Single-molecule medicine is the predominant corporate way, the FDA-approved way, but it’s not the only way, and it’s not necessarily the optimal way to benefit from cannabis therapeutics. Cannabis contains several hundred compounds, including various flavonoids, aromatic terpenes, and many minor cannabinoids in addition to THC and CBD. Each of these compounds has specific healing attributes, but when combined they create what scientists refer to as a holistic “entourage effect,” so that the therapeutic impact of the whole plant is greater than the sum of its single-molecule parts. The Food and Drug Administration, however, isn’t in the business of approving plants as medicine. (See the scientific evidence.) “Psychoactivity is inherently an adverse side effect.” According to politically correct drug war catechism, the marijuana high is an unwanted side effect. Big Pharma is keen on synthesizing medically active marijuana-like molecules that don’t make people high—although it’s not obvious why mild euphoric feelings are intrinsically negative for a sick person or a healthy person, for that matter. In ancient Greece, the word euphoria meant “having health,” a state of well-being. The euphoric qualities of cannabis, far from being an unwholesome side effect, are deeply implicated in the therapeutic value of the plant. “We should be thinking of cannabis as a medicine first,” said Dr. Tod Mikuriya, “that happens to have some psychoactive properties, as many medicines do, rather than as an intoxicant that happens to have a few therapeutic properties on the side.” “CBD is legal in all 50 states.” Purveyors of imported, CBD-infused hemp oil claim it’s legal to market their wares anywhere in the United States as long as the oil contains less than 0.3 percent THC. Actually, it’s not so simple. Federal law prohibits U.S. farmers from growing hemp as a commercial crop, but the sale of imported, low-THC, industrial hemp products is permitted in the United States as long as these products are derived from the seed or stalk of the plant, not from the leaves and flowers. Here’s the catch: Cannabidiol can’t be pressed or extracted from hempseed. CBD can be extracted from the flower, leaves, and, only to a very minor extent, from the stalk of the hemp plant. Hemp oil start-ups lack credibility when they say their CBD comes from hempseed and stalk. Congress may soon vote to exempt industrial hemp and CBD from the definition of marijuana under the Controlled Substances Act. Such legislation would not be necessary if CBD derived from foreign-grown hemp was already legal throughout the United States. “'CBD-only’ laws adequately serve the patient population.” Fifteen U.S. state legislatures have passed “CBD only” (or, more accurately, “low THC”) laws, and other states are poised to follow suit. Some states restrict the sources of CBD-rich products and specify the diseases for which CBD can be accessed; others do not. Ostensibly these laws allow the use of CBD-infused oil derived from hemp or cannabis that measures less than 0.3 percent THC. But a CBD-rich remedy with little THC doesn’t work for everyone. Parents of epileptic children have found that adding some THC (or THCA, the raw unheated version of THC) helps with seizure control in many instances. For some epileptics, THC-dominant strains are more effective than CBD-rich products. The vast majority of patients are not well served by CBD-only laws. They need access to a broad spectrum of whole plant cannabis remedies, not just the low THC medicine. One size doesn’t fit all with respect to cannabis therapeutics, and neither does one compound or one product or one strain. “CBD is CBD—It doesn’t matter where it comes from.” Yes it does matter. The flower-tops and leaves of some industrial hemp strains may be a viable source of CBD (legal issues notwithstanding), but hemp is by no means an optimal source of cannabidiol. Industrial hemp typically contains far less cannabidiol than CBD-rich cannabis. Huge amounts of industrial hemp are required to extract a small amount of CBD, thereby raising the risk of toxic contaminants because hemp is a “bio-accumulator” that draws heavy metals from the soil. Single-molecule CBD synthesized in a lab or extracted and refined from industrial hemp lacks critical medicinal terpenes and secondary cannabinoids found in cannabis strains. These compounds interact with CBD and THC to enhance their therapeutic benefits. www.projectcbd.org/article/cbd-misconceptions
|
|
|
Post by lakers on Dec 25, 2015 15:44:02 GMT -5
First thing first, higher priority is given to label improvement which helps place Afrezza in Tier 2 and justify premium price in U.S. EU pricing follows precedence in U.S. ME pricing follows precedence in EU and U.S. Superiority Trial should start 1Q16 if not Jan.
Is the trial registered with fda yet or the meeting findings in San Diego being drafted? Sanofi is in charge of superiority study which has not been registered w/ FDA yet.
|
|
|
Post by lakers on Dec 25, 2015 15:39:22 GMT -5
First thing first, higher priority is given to label improvement which helps place Afrezza in Tier 2. And I will be static when I see some actual prove that Sanofi is pushing for this. Logic would dictate that they are working on it or should be working on it, but corroboration, other than speculations about the San Diego meeting, would be a nice thing to have. Label improvement initiative has been publicly disclosed in a slide. Please search and post. I am certain you can find it.
|
|
|
Post by lakers on Dec 25, 2015 15:32:14 GMT -5
I would like to see MNKD start a long term study on pre diabetics to assess whether AFZ can stop the progression of disease. First thing first, higher priority is given to label improvement which helps place Afrezza in Tier 2 and justify premium price in U.S. EU pricing follows precedence in U.S. ME pricing follows precedence in EU and U.S. Superiority Trial should start 1Q16 if not Jan. I agree w/ the criticism that it should have been started 6 mos ago. Requirement/Commitment Number 2 Required Under FDAAA Section 505(o)(3) Original Projected Completion Date 03/31/2017 Description Conduct a dose-ranging PK-PD euglycemic glucose-clamp trial to characterize the dose-response of Afrezza relative to subcutaneous insulin in patients with type 1 diabetes. Select at least three to four doses for each route of insulin administration to ensure both the linear and curvilinear portions of the dose-response curves are adequately captured and characterized. Compare the dose-response curves for Afrezza and subcutaneous insulin noting the dose at which the response becomes curvilinear for each. These data may impact labeling recommendations for dosing and thereby mitigate the risk of diabetic ketoacidosis, which has been observed with Afrezza. Current Status Ongoing Requirement/Commitment Number 3 Required Under FDAAA Section 505(o)(3) Original Projected Completion Date 01/31/2017 Description A PK-PD eugylcemic glucose-clamp trial to characterize within-subject variability for Afrezza pharmacokinetic (PK) and pharmacodynamic (PD) parameters. These data may impact labeling recommendations for glucose monitoring and thereby mitigate the risk of hypoglycemia, which has been observed with Afrezza.
|
|
|
Post by lakers on Dec 25, 2015 15:05:51 GMT -5
Looking ahead to 2016, we’re optimistic about these seven diabetes products potentially hitting the market in the next 12 months. asweetlife.org/feature/7-new-diabetes-products-to-look-for-in-2016/Insulet’s Omnipod Phoenix PDM Insulin Pump Photo courtesy of Diabetes Mine At the ADA Scientific Sessions in Boston this June, Insulet teased the crowd with a first look at the next generation controller for their popular patch insulin pump, the Phoenix PDM (Personal Diabetes Manager). The chunky plastic PDM controllers we saw in the UST200 and UST400 models will give way to a sleek, sexy color touchscreen interface. The Phoenix will be thinner than the UST400, black in color, and resemble a smartphone. Though the Phoenix will be Bluetooth-enabled, this PDM will not yet be integrated with the Dexcom G5, though we should see that product quickly on its coattails given that value-added capability. When might we see the Phoenix rise? In their Q3 earnings call on 5 November, Insulet CEO Patrick Sullivan said they are “on track to submit our Phoenix PDM product to the FDA in the middle of next year, and we would expect to have that on the market or approved by the end of next year.”
|
|
|
Post by lakers on Dec 25, 2015 14:59:08 GMT -5
Real news on next 2 in the pipeline or EU approval? Sanofi hasn't filed EMA, ME MAA's yet. But that may change next year. Sanofi is obligated to inform Mnkd immediately after they file. I agree that superiority clinical study duration is about 7 mos after recruiting ends, long enough to measure A1C at least once or twice, hypo events, weight loss, cardio events, lung capacity at least once after 6 mos, time in range, 46 participants. The big Q is will Sanofi wait till the superiority trial finishes to file MAA or file it first, then apply for label change just before final approval b/c the longest pole will be 210 days max coinciding w/ 7-mo superiority trial. Regardless, all analysts covering Mnkd agreed that MAA would be a catalyst for pps. Next partnership will be pain, migraine mgmt, ready for human clinical trials. A Superiority Trial Case Study, 6 mos, 404 PWDs. Novo Nordisk's Victoza beats Sanofi's lixisenatide in type 2 diabetes study - NVO | Seeking Alpha [Sny should have fought back by comparing Afrezza to Novolog, Humalog, and developed inhaled GLP-1] Sep. 16, 2015 10:42 AM • SA Editor Douglas W. House Results from a Phase 4 study, called LIRA-LIXI, comparing Novo Nordisk's (NVO -0.1%) Victoza (liraglutide) to lixisenatide (Sanofi (SNY +1.4%)), both in combination with metformin, showed treatment with liraglutide lowered HBA1c -1.83% versus -1.21% (p<0.0001) significantly greater in patients with type 2 diabetes. The results were presented today at the 51st Annual Meeting of the European Association for the Study of Diabetes in Stockholm, Sweden. Data from the 26-week 404-subject trial also showed that liraglutide produced significantly greater reductions in fasting plasma glucose (p<0.0001) and mean nine-point self-measured plasma glucose (p<0.0001) compared to lixisenatide while producing greater postprandial increments for the meal following injection (p<0.0001). The safety profile was similar between the two groups. Victoza was administered once daily at any time irrespective of meals while lixisenatide was administered once-daily within an hour prior to the morning or evening meal. Victoza, a GLP-1 analog, was launched in the EU in 2009. A recombinant version was approved by the FDA under the brand name Saxenda in December 2014. Sanofi intends to file its NDA (brand name LixiLan) with the FDA in Q4 and its MAA in the EU in Q1 2016. Read more: mnkd.proboards.com/thread/4224/snys-inhaled-lyxumia-glp-ra#ixzz3vMe2mi7F
|
|
|
Post by lakers on Dec 25, 2015 14:09:07 GMT -5
Sanofi takes an FDA shortcut with its diabetes combo, racing with Novo Sanofi ($SNY) is using its $245 million coupon for a quick FDA review to speed up the approval process for a combination of its top-selling insulin and a new diabetes drug, angling to beat rival Novo Nordisk ($NVO) to the market. The French drugmaker filed an FDA application for LixiLan, a fixed-dose injection that combines the blockbuster Lantus with lixisenatide, an investigational Type 2 diabetes treatment that works by boosting the hormone GLP-1 to increase natural insulin production. In tandem, the two therapies significantly reduced blood sugar in a Phase III program involving roughly 2,000 patients, Sanofi said. To move things along with LixiLan, Sanofi redeemed an outstanding priority review voucher, which shortens the standard FDA review time for submitted drugs from 10 months to 6 months and will kick in once the agency accepts the company's application. Sanofi picked up its voucher earlier this year in a deal with Retrophin ($RTRX), paying $150 million up front and promising to disburse installments of $47.5 million in 2016 and 2017. Sign up for our FREE newsletter for more news like this sent to your inbox! The goal is to get to market before diabetes magnate Novo, which submitted a similar combo for FDA approval in September. That cocktail therapy, sold in Europe as Xultophy, pairs Novo's blockbuster GLP-1 treatment Victoza with the recently approved insulin Tresiba and has charted excellent clinical results over the past few years. Sanofi is working to stay afloat in a changing diabetes market, preparing to face biosimilar competition for Lantus that will imperil the treatment's roughly $8 billion in annual revenue. Earlier this year, the company disappointed analysts with the revelation that diabetes sales are likely to slip about 7% in 2015 and decline well into 2018, as new products including the Lantus heir Toujeo have underperformed expectations. Sanofi has used the priority review program to win a blockbuster race in the past, joining partner Regeneron Pharmaceuticals ($REGN) last year to trade $67.5 million for a voucher that helped the pair leapfrog Amgen ($AMGN) in the race to commercialize new treatments for high cholesterol. The priority review voucher program, which allows any company to cut the line at the FDA for a price, has come under scrutiny over the past year. Introduced in 2007, the system awards a coupon for quick review to any company that successfully develops a treatment for a rare pediatric disorder or neglected tropical disease, and that asset can be sold to the highest bidder. While that has proven lucrative for companies with vouchers--the last one sold for $350 million--it forces the FDA to interrupt its other public health work to fast-track new, possibly marginal treatments. And companies can obtain these increasingly valuable assets without inventing drugs on their own, a facet of the program that led the former Martin Shkreli-helmed KaloBios ($KBIO) to acquire an old antiviral treatment in hopes of winning FDA approval and picking up a sellable voucher. www.fiercebiotech.com/story/sanofi-takes-fda-shortcut-its-diabetes-combo-racing-novo/2015-12-23Sanofi is trying to gain approval ahead of competitor Novo Nordisk, which filed a new drug application in September for its experimental diabetes medication Xultophy, a combination of its insulin medicine Tresiba and its blockbuster GLP-1 agonist Victoza. But Sanofi has the benefit of holding a priority review voucher, which it purchased from Baltimore-based Asklepion Pharmaceuticals for $245 million in May. Sanofi redeemed the voucher to shorten the review time to six months from 10. It's a move the company has used before. In 2014 Sanofi and partner Regeneron bought a voucher from California-based BioMarin Pharmaceutical for $67 million. The companies then redeemed the voucher in order to fast-track review of its cholesterol-lowering drug Praluent, which won FDA approval a month ahead of rival Amgen's medication Repatha. The FDA grants a voucher as a reward when a company develops and gets approval for a treatment of one of 17 tropical diseases or develops a therapy for a rare pediatric condition that affects more than 50% of those under the age of 18 and has fewer than 200,000 U.S. cases. A voucher holder can either redeem it to expedite review of one of its other drugs or turn around and sell it to another company, which has created a secondary market that can yield hundreds of millions of dollars for the seller. www.modernhealthcare.com/article/20151223/NEWS/151229941[Mnkd should have started a tiny biz developing these drugs instead of some oncology to win FDA vouchers, then sell them to highest bidders ~ $0.5B each to realize Afrezza and TS pipeline fullest potential. Furthermore, Sanofi might want to negotiate bundle deals, T&A, and L&A w/ PBMs to preempt Novo's next gen. Exclusive deals would be great.]
|
|
|
Post by lakers on Dec 24, 2015 15:27:58 GMT -5
Real news on next 2 in the pipeline or EU approval? Sanofi hasn't filed EMA, ME MAA's yet. But that may change next year. Sanofi is obligated to inform Mnkd immediately after they file. I agree that superiority clinical study duration is about 7 mos after recruiting ends, long enough to measure A1C at least once or twice, hypo events, weight loss, cardio events, lung capacity at least once after 6 mos, time in range, 46 participants. The big Q is will Sanofi wait till the superiority trial finishes to file MAA or file it first, then apply for label change just before final approval b/c the longest pole will be 210 days max coinciding w/ 7-mo superiority trial. Regardless, all analysts covering Mnkd agreed that MAA would be a catalyst for pps. Next partnership will be pain, migraine mgmt, ready for human clinical trials.
|
|
|
Post by lakers on Dec 24, 2015 15:00:16 GMT -5
DeSisto wouldn't come out of retirement to join if he didn't think there is a tremendous upside potential. Under his stewardship, PODD appreciated significantly during 2003 to 2014. IMHO, we bottomed out at $1.5. The new CEO starts a new dawn of prosperity. What better way than starting him at rock bottom, there is nowhere to go but up. The co positions him at an optimal time to ensure his eventual success. Can you guess what comes next?
|
|
|
Post by lakers on Dec 24, 2015 13:28:42 GMT -5
Lakers, did you know potential to announce was even prior to 1q 16? Interesting on your calls, I don't care to now how/why.
Yes. Had the co not announced before 12/24, it will not have announced on 12/28-12/31 but 1/4/16. The holiday heavy window necessitates mgmt to either announce on 12/23 or 1/4/16 before DeSisto joins 1/5. That's why I later said the news was very close, imminent. Glad you saw that, very perceptive ! Water under bridge, What's next is more interesting.
|
|
|
Post by lakers on Dec 23, 2015 13:38:40 GMT -5
|
|
|
Post by lakers on Dec 23, 2015 3:52:43 GMT -5
To create pull demand, Sanofi could have played ads in 4,134 different American movie theaters which are showing The Force Awakens, according to BGR, and many have the movie playing in multiple theaters — some even offering it in standard format, 3D, and IMAX 3D viewing. This is effective and costs much less than national broadcast TV.
NBC 48hrs, ABC 20/20, CBS 60 minutes about Al's life accomplishment and/or Afrezza would gain mindshare for Afrezza free of charge.
Afrezza Superiority Study, Affinity 2 published on NEJM would gain millions of mindshare for Afrezza, free of charge.
I think, the new CEO will release a couple of good news in 1Q16. I don't see why CMO can't grant an interview to articulate his vision and the new CEO to explain the new business model.
Mnkd should try to get some Gates Foundation grants for TS pipeline. This will lead to future partnership. For TS Oxytocin, Minkata Foundation already got the grant.
Sanofi should consider expanding in the most populous BRIC concurrently w/ EU, ME followed by AP.
Most importantly, Sanofi should start superiority study immediately. That's the key to move Afrezza to Tier 2 and justify the premium price worldwide.
It's about time to allow Sanofi buys in 10% at a privately negotiated price using an annual worldwide peak sale of $2B in 5 years now that both parties realize that Mnkd needs funding to realize Afrezza and TS pipeline long term potential.
|
|