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MERCK Keytruda approved for Lung Cancer.
ONCS combination therapy another possible approach
to enhance efficacy for Keytruda.
Would only make sense for a new trial to incorporate ONCS
tech with this form of cancer as well.
http://oncosec.com/oncosec-technologies/combination/
FDA Approves Merck's Keytruda for Most Common Form of Lung Cancer -- Update
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By Peter Loftus
The U.S. Food and Drug Administration approved Merck & Co.'s Keytruda for the treatment of the most common form of lung cancer, the second of a costly new wave of immune-boosting drugs to be cleared for one of the deadliest cancer types.
The FDA cleared Keytruda for use in patients with non-small-cell lung cancer whose tumors contain a certain level of a protein known as PD-L1, and whose disease continued to worsen after the patient received chemotherapy or other drugs. The FDA also approved a companion diagnostic developed by Dako North America Inc. to test for PD-L1, to screen for patients who should receive Merck's Keytruda.
A Merck-funded study found that Keytruda worked better in lung-cancer patients with higher levels of PD-L1 than in patients with lower or undetectable levels. Merck estimates roughly 25% of all non-small-cell lung-cancer patients have PD-L1 levels that would make them eligible for Keytruda treatment, Roger Perlmutter, Merck's research chief, said in an interview Friday.
Merck shares rose 1.6% Friday, after initially declining on the news. Some analysts say the requirement that Keytruda be used in PD-L1-positive patients could provide a competitive advantage to a rival drug from Bristol-Myers Squibb Co., Opdivo, which isn't limited to PD-L1-positive patients.
Keytruda joins Opdivo as a new immunotherapy option for certain patients with non-small-cell lung cancer, which accounts for about 85% to 90% of all lung-cancer cases. The National Cancer Institute estimates 221,200 Americans will be diagnosed with lung cancer this year, and 158,040 will die from it.
Both Keytruda and Opdivo work by blocking a substance on immune cells known as PD-1, disrupting its interaction with PD-L1 on cancer cells. This lifts a natural brake on the immune system and allows it to kill cancer cells. Doctors believe the anti-PD-1 drugs have potential to transform treatment of multiple tumor types, based on clinical trials showing improvements in survival and tumor-shrinkage rates versus some older treatments.
Analysts estimate the class has multi-billion-dollar sales potential--fueled by hefty prices. Keytruda and Opdivo both cost about $12,500 a month per patient, or $150,000 if used for a full year. Both drugs were previously approved to treat melanoma. Merck recorded $192 million in Keytruda sales for the first six months of 2015.
On Thursday, the FDA approved the use of a combination of Opdivo and an older Bristol immunotherapy, Yervoy, for the treatment of melanoma. The two-drug combination would cost about $256,000 for the first full year.
Expanding the use of these high-price immunotherapies to multiple tumor types could pose a new cost burden for insurers and other payers. In May, Leonard Saltz, an oncologist from Memorial Sloan Kettering Cancer Center called prices for new cancer drugs "unsustainable" in a speech at a meeting of cancer doctors.
FDA approval of Keytruda for lung cancer was based partly on a study showing it significantly shrank tumors in about 19% of lung-cancer patients. Among those with a certain level of PD-L1 expression, the response rate was 41%, according to the FDA. The most common side effects of Keytruda include fatigue and breathing problems.
"I think there's going to be more and more interest on the part of oncologists in using PD-L1 expression in making decisions about how best to treat their lung-cancer patients," Merck's Dr. Perlmutter said.
Write to Peter Loftus at peter.loftus@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
October 02, 2015 17:11 ET (21:11 GMT)
GE continues to mention how big they are becoming on the technology and software side of things. Plan on growing their business with various softwares and application of their recent cloud and big data advances.
Once they merge their manufacturing capabilities with their big data capabilities, sglb tech could fit right in and make everything possible while they print certifiable 3d parts in a mass production setting.
I can imagine this all coming together over the next few years.
Exciting times for SGLB and the future of manufacturing.
Advancing inspection
Mass production is the next step in additive manufacturing for aerospace components, saysSpartacus3D CEO Charles de Forges. Based in La Clayette, France and part of Paris-based Farinia Group, the company uses SLM and EBM processes to build parts. Titanium and Inconel 718 are priority materials, according to de Forges. Static parts are on the docket, with rotating parts further down the road.
The qualification process to inspect parts made using 3-D printing is the next development front. “Everything that I’ve seen so far has been inspired by casting, including x-ray inspection and fluid penetrant testing, similar to what’s used in forging and casting,” says de Forges.
Aerojet Rocketdyne relies on a combination of select traditional nondestructive inspection processes combined with closely controlled additive processes. “There’s still a lot of work to do to develop the ability to perform in situ process monitoring it for qualification,” Littles says.
Process monitoring, inspection, the digitization of the production environment, and using that in a meaningful way to control the process, is what “it’s all about,” adds Gardner.
General Electric designers and engineers believe the latest advances in the last two to three years have not been around the core technology but rather more around using process monitoring for general quality assurance, says Rengers. “Nondestructive means a combination of CT scans and x-rays—it won’t be one or the other. Moving forward, there will be a migration to more quality assurance of the process versus post-process inspection.”
The learning curve stretches onward. “There are so many knobs and dials that we can turn—we don’t have them all figured out yet—not to say that we won’t,” Penn State’s Simpson says. “Companies are spending money to figure this out, but they won’t share that information because of the competitive advantage it provides. We’re trying to get the knowledge out there by collaborating with many companies and sponsors. It’s part of our center’s mission as DARPA’s Manufacturing Demonstration Facility for Additive Manufacturing and our partnership with America Makes.
“Two and a half years ago when I gave tours [of the CIMP-3D facility], people were asking, ‘Can you really 3-D print metal parts?’ and then we’d show them sample parts,” Simpson continues, adding that expectations have since risen significantly. “Now they’re asking: ‘When can we start making multi-material parts?’” FFJ
Uplist won't happen until S3 is completed to raise the 25 million, or at
least a significant portion of it, so that our balance sheet reaches the
requirements for a better exchange.
And that can't be executed until we hit a $75milion valuation
which probably won't occur until news of revenues are posted.
So there is still some time and hurdles before that happens, but
basically getting in before any of that should be lucrative to
investors.
After that it should be smooth sailing.
GE gas and power conference over the next couple days.
Many speaking topics titles relate to manufacturing and analysis of data.
Very exciting times.
Updated the intro to current applications and products.
Will take more time to make it more eye catching when i have the chance.
GLTA
There she goes...time to move that cash around and get ready to
buy some more folks.. waiting for hard support levels around
5's.
Revenues and news coming soon. Too good at these prices!
I agree...I keep getting surprised it has lasted this long...these penny stocks r tricky to chart...especially one with so much hype behind it.
I understand there's limited metals and variations but I just found it odd they advertise ONLY that type right before Honeywell releases an article about how they use the same type for their aerospace applications.
Interesting sigmalabs linked in, posts about Inconel 718 a few days ago, and the today posts a page from Honeywell using
Inconel 718 with their ebm technology.
All right after the latest announcements of partnerships and expanding the early adopter programs
Stratasys acquired harvest technologies which had
40 printers. Doesn't disclose how many were metal
but it sounds like a majority were DMLS or SLS
so SGLB tech is compatible even if they weren't all
metal printers.
But like mentioned Vivek did say they seemed to
be entering the composite arena as well.
GE is going to compete with Pratt and Whitney who has been
the leader in turboshaft engines.
Could mean some big bucks for them as they are putting half a billion
into this program I'm sure they expect some large returns.
And if their product is going to compete, it may need some AM parts...
http://www.businesswire.com/news/home/20150917005622/en/GE-Aviation-Create-European-Turboprop-Center-Excellence#.VfxieFxdURk
This pop is probably exactly what the mms and shorters have been waiting for...30% + profit margins coming for them
Right on rfb. Expecting another high short percentage coming yet again.
Good program and expansion of sales activity but until the revenues are posted, which looks like they won't be until the 10k next year, we are still at a standstill.
Accumulation in full steam once we dip down to support levels.
Whoops, it came up in my news feed, thought it was new. My bad.
Arcam AB's New 3-D Printer Takes Off With Aerospace Companies
Arcam (NASDAQOTH: AMAVF ) released its second-quarter 2014 earnings on July 18.
More aerospace news, talks about GE
http://www.fool.com/investing/general/2014/07/26/arcam-abs-new-3-d-printer-takes-off-with-aerospace.aspx
The mms always win with this one simply bc they have more money to risk...sglb is still far to risky and unknown to the average investor and investment firms. Until we uplist or post huge deals with huge companies, the mms will continue to slam every rally.
Maybe its already a sure thing.
SGLB has well positioned their technology to grow with the AM
market.
Has been a long a grueling process but I believe the fruits of all
this labor will be well worth the wait.
The only thing missing, that has been since inception of Sigma
Labs is the revenue.
The AM market projections is all we have to look at, hoping and
dreaming those dollar signs make it on to paper.
It is only a matter of time now, a thing no one can control.
I just hope things continue on the path they are on.
As Ive said the past 5 years, next year is going to be a great
year.
The questions are...
How much did they spend for this exclusive license?
What new studies and trials are going to occur with this
technology?
How much are those trials going to cost?
All these questions are unanswered, the only question and answer
that is almost certain...
Where is all this money going to come from?
Investors pockets.
Looking for some help.
I recently have been working on my technical skills and
found the indicator of the accumulation/distribution line
to be very helpful.
However, Ive come across a stock who's accumulation/distribution
is regularly around -10million on the month and around -150k on smaller
charts like the month chart.
I was wondering how this plays out with the accumulation/distribution always being
in the negative..does this mean someone is just dumping shares over time ?
I don't see how the accumulation distribution is so low when the stock price
still has a normal up and down pattern or stays the same.
Thank you for your help
Emailed spartacus 3d
Spartacus has 3 printers as of now.
Sigma Lab's EAP is being offered to qualified customers around the globe, allowing early access to participate in evaluation and trial of the Company's software and engineering services. Sigma Labs will accept entrants in the program through the end of 2015; - See more at: http://globenewswire.com/news-release/2015/09/01/765129/10147726/en/Sigma-Labs-Announces-Launch-of-Early-Adopter-Program.html#sthash.tYruoM4P.dpuf
Key words
Allowing early access to participate in EVALUATION and TRIAL of the company's software and engineering services.
Sigma Labs will accept entrants in the program thru the end of 2015.
So to me this sounds like some of the software (DEFORM and ANALYTICS) may still be being developed and tested until we hear otherwise. And also, SGLB is accepting entrants to test their software all the way thru the end of 2015, so who knows when we will see any significant revenues from this program.
Not sure how this affects SGLB either for the better or
for worse, but idk if this connection has been made before
or pointed out.
Sigma Labs received technical advice on their product
via Sandia National Labs, a subsidiary of Lockheed Martin Corporation.
How much advice they gave them regarding the product I
do not know, but Sigma does hold the patent so that has
to be good. But Lockheed has to be up to date on this
software and most likely has a kind of their own, who knows.
But another (possibly big) or negative if they have their own
Inspection technology.
The Sandia National Laboratories, managed and operated by the Sandia Corporation (a wholly owned subsidiary of Lockheed Martin Corporation), are two major United States Department of Energy research and development national laboratories.
http://www.sandia.gov/working_with_sandia/technology_partnerships/_assets/documents/2014NMSBAperspectivesFY13_FNL.PDF
http://shortanalytics.com/getshortchart.php?tsymbol=sglb
Squeezing for now but most likely will fall lower.
Bring us some revenues!
I didn't say they would need to issue shares, just that our valuation may see a decrease in value if we incur more expenses without additional revenues.
He may have exaggerated and fabricated some conclusions, but I think his main point was that sglb will have increased expenses and if there is no revenue to counteract this, we will see some loss in our current valuation.
I agree with him on that.
However we will not now until the 10k about the spending and we will not know about revenues until they happen.
http://m.scmp.com/tech/science-research/article/1854369/just-beginning-china-approves-worlds-first-3d-printed-hip
Done on an Arcam printer in Sweden.
I actually agree with you for once RFB, except the last sentence.
I don't believe they will need to raise funds until after securing some revenues to up their pps for a more favorable uplisting move.
They know they can't raise funds right now, they know they can't uplist without revenue.
They will secure revenue, raise funds via s3 then uplist. imo this is their best option and a familiar route many companies in similar positions pursue.
Interesting they are working in very similar areas as GE
Oil and Gas
Aerospace
Defense
Big markets, big money.
Have a feeling our shorter friends will be back since this is
great news, but still ultimately a non-revenue event, expecting
revenues to come in the future.
So, I have a bid in, a bit lower than current prices, to see
the price action over the next couple
days and weeks before october first.
I don't know how long ill let it sit as we are getting too close
to substantial contracts to miss out for 15-20 percent discount.
Ive gotten trigger happy before so I might just buy more
sooner than I expect.
GLTA
Thanks Jackle great work
Anyone find a valuation on this farinia group? I'm at work and can't do right now,
Any idea how big this group is or how large their AM sector is?
He literally just started lol.
I was hoping they would have some news of contract printing last er, since they've had the printer installed for a hot minute now.
Hoping they had something in the works just not on paper yet.
Theres always next ER...
I have. And the mods could literally copy and paste some of them onto the main part of the board to make it a little more presentable.
Again. It was just a suggestion.
MODS could really update this board with some recent pictures, links, and findings of our employees referring to immunotherapy and electroporation.
I know it takes some time (I've designed a board or two myself) but it really helps bring a board together and can catch the eye of new investors.
Just a thought.
GLTA
Common stock authorized - 160,000,000 common shares with a par value of $0.0001, common stock issued and outstanding — 12,351,763 and 12,231,554 common shares as of April 30, 2015 and July 31, 2014, respectively (1)
Meaning there's room for oncosec to dilute up to approximately 148,000,000 shares.
This information is from the latest 10Q.
As of now they have No provisions to do so, however, if capital becomes an issue, as it will be in 2016, the risk becomes very real for current stockholders if no significant findings have been made in terms of the technology and the company's valuation.
Only thing that worries me right now is that there's only 12 million shares outstanding out of 150 million authorized.
Hopefully the price is greatly inflated before they need to raise capital, because there is a lot of room to go...
http://www.gereports.com/post/127494193470/talkin-bout-power-generation-how-an-english
Power generation also going thru new designs. Possibly AM designs. Exciting times.
ESNC was able to secure agreement with SPI, shows long term possibilities evident.