IMO, it's highly conceivable that appointment assurances from high ranking officials (within the Admissions chain) were offered to Ben Carson, particularly in view of the affirmative action and diversity policies promulgated and enforced at that time. Make no mistake, the Academy appointment process back then was highly scrutinized and overseen to ensure compliance to affirmative action mandates. While Ben Carson should have been more specific from the start, I do give him the benefit of doubt. Having myself been a minority awarded with a service academy appointment when affirmative action policies "ruled" the day (38 years ago), I can appreciate how someone wouldn't necessarily offer up extensive details of the appointment process.
If it walks like a duck, talk likes a duck ... it's a DUCK! You got Sanofi pegged! However, they're still a solid company that knows how to market a new "paradigm" changing drug. And, because inhalable drugs are still tabooed by many in the medical industry, it makes a lot of sense to slowly introduce Afrezza by riding on the coat tails of an already established and accepted delivery system.
Another patent of interest with the Korean IPO includes;
GLUCAGON-LIKE PEPTIDE 1 （ＧＬＰ-1）PHARMACEUTICAL FORMULATIONS (Application date 2015.04.02, Registration pends): The present invention discloses the composition mixing the Glucagon-like peptide 1 (GLP-1) particle with the diketopiperazine (DKP) which is stable in vitro and in vivo both and includes. The composition has the utility as the pharmaceutical preparation for being the same as that of the diabetes, and the cancer and adiposity but such disease or the disease which is not restricted to the disease being cured. Particularly, the composition has the utility as the pharmaceutical preparation for the pulmonary delivery.
Does anyone know if this the GLP-1 that can be further developed into possible long-acting diabetic uses and other pharmaceutical applications???
I was able to find this patent on the Korean Intellectual Property Office website. It shows the initial application as 2015.03.27, with registration date still pending/not issued. Perhaps the recently announced submission (2 Nov) is an amendment to the original patent; or is now just getting news recognition; or better yet, preceding an announcement of completed final registration (wishful thinking, I know).
Patent Abstract reads ..."METHOD AND COMPOSITION FOR TREATING HYPERGLYCEMIA: In the present invention, provided is the composition for the treatment of the disease including the hyperglycemia of the object and/or the diabetes and the obesity and/or the failure and method. In the present invention, particularly, it is provided to include the dry powder composition of the GLP-1 analogs including the dry powder oral inhalation system is the PEG -GLP-1 molecule and the diketopiperazine."
Interestingly, within the patent details it identifies other "family patents" with Australia, Canada, Japan, European Patent Office, World Intellectual Property Organization (WIPO), and of course the US.
Mannkind has applied several patents relating to Ultra Rapid Acting Insline, Dry Powder, etc... and the Inhaler Device with the Korean Intellectual Property Office over the last several years. When searching the Korean IPO website, I could not find a patent application dated Nov 2, 2015. Can you provide the title of the Patent?
Fraz, did you happen to catch the latest news broadcast aired 11/03/15 by Channel 10 (WPLG) interviewing an Afrezza patient? Speaks volumes! Google "New form of insulin helps some diabetes patients manage disease." Anticipate more of this freebie news advertising in the coming months, especially after Sanofi's DTC campaign hits the airwaves. Continuing to add on the dips.
Be sure to watch Channel 10's interview of an Afrezza patient...far better than anything Sanofi has come up with to date. Just Google "New form of insulin helps some diabetes patients manage disease." It was aired on 3 Nov 2015.
Timing of this amended restatement for the 10 million preferred shares was one month before FDA approval of Afrezza and 4 months before the Sanofi collaboration and license agreement. As Proulxra suggests, Al Mann's long-term plan IMO appears to be culminating ... "10,000,000 shares is akin to a 2.5% stake and falls within the parameters that the partnership agreement sets for SNY's current limit. Preferred shares signify a planned private placement of some sort in my estimation."
And, now with the 9 million preferred shares returned back to MNKD from B of A, the coffers are full to move into the next phase ... whatever that may be. Anyone's guess at this point ... but, my bets are (and will continue to be) on Al Mann.
Yes, really intrigued about the 12-month preliminary findings from the phase I/IIa dose finding trial of GALE-301 (a folate binding protein vaccine) in ovarian and endometrial cancer patients to prevent recurrence.... "In the optimal 1000 mcg vaccine dose group (VG), the clinical recurrence rate is 13.3% versus 55% in the control group (CG) (p=0.02), providing for a two-year Disease Free Survival estimate of 85.7% (VG) versus 33.6% (CG), p
Same here Fraz. Didn't get them as good as a $1.34/share though (1.45 instead). MD Anderson and Mittendorf's backing (and now NIH) keeps me committed to Gale.
"If I'm SNY why not simply wait until MNKD gets into serious financial straights then snag the company for a song?"
To my knowledge, there's nothing preventing MNKD to enter into a buyout agreement with Sanofi's competition at anytime. If you believe in the science, and that Afrezza (and Technosphere) has blockbuster potential; then reliable and ethical partnering relationships yields the next best thing to "exclusive rights of purchase." IMO, Sanofi will prevent at all costs potential circumstances that could invite a bidding war among competitive interests.
Yes, really interesting commercial. IMO, whether for Neuvax or FBP, all very good for Gale and the entire "vaccine--checkpoint inhibitor" combo immunotherapy platform.
You're correct that data to be presented at ESMO is for the Phase I/IIa FBP (E39+GM-CSF) trial. The key point to take away is that upcoming ESMO data is "more developed" than what was presented at ASCO earlier this year. If you compare the pre-published ESMO abstract with earlier released ASCO data, you will find distinctions between the two. IMO, the ESMO presentation will serve as a positive catalyst, providing increased pps momentum (and support) going forward until announcement of interim Nuevax results. Also, FBP significantly strengthens the pipeline and serves to reduce overall investor risk; thereby attracting greater IO interest.
Agreed. Bondholders (2017/18) should be very nervous about debt being "unsecured" in today's challenging oil pricing environment and will undoubtedly push negotiations towards a "secured" status. I suspect bondholders/Exxi are currently splitting hairs over extension and interest reduction details. Now that the Federal Reserve decision (not to raise rates) is established, this should lend some underlying pricing support going forward; thereby helping to move negotiations along.
Well, then it's a darn good thing that the 2017 "unsecured" bond debt isn't due for another two years, and the 2018 due in three years. Not too shabby, that gives EXXI two more years to burn thru their $800+ million in cash before bondholders can get anything over interest payments. If bondholders are smart, they'll negotiate for something before then ... probably some form of "secure" debt position in exchange for extension. IMO, seems like EXXI is holding a pretty good negotiating hand.
Glad to see this press release giving updated proved reserve valuation, especially with impending restatement of financials (due to change in derivative accounting method). Noteworthy points from press release ...
"Our proved reserves decreased primarily due to production of 22 million barrels of oil equivalent ("MMBOE") during fiscal year 2015, as well as the divestiture of non-core assets, price-based adjustments, and our reduced capital expenditures due to the current low commodity price environment, ... Our Fiscal Year 2015 reserve additions of 17 MMBOE demonstrate our ability to continue to replace our reserves organically while upgrading our portfolio by delivering on the divesture of our higher cost, non-core properties... The reserves that we lost to price and reduced forecasted capital expenditures over the next five years don't simply go away; those hydrocarbons are still in the ground and as prices recover we expect to once again realize the value of those barrels ... The company has proved "and" probable reserves totaling 265.7 MMBOE, with a present value of $4.5 billion.... "
"The reserves are reported as of June 30, 2015 and "do not" include the reserves, or present value attributed to the M21K, LLP acquisition which closed August 11, 2015. At the time of closing, the proved reserves associated with the M21K, LLP assets were estimated at 13 MMBOE with a present value of $82 million at strip prices. The company is working with reserve auditors to complete those estimates. The reserves associated with the M21K, LLP acquisition have never been included in the company's reserves."