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Saturday, August 29, 2015 7:10:29 PM
Quote BS LOL, "PHASE2 TO START WITHIN THE NEXT 31 DAYS!!!
If it hasn't already!!!"
WHAT???????? Based on WHAT FACTS????????
The phase 2 WAS (as in PAST TENSE, as in LATE NOW) SUPPOSEDLY GOING TO START PRIOR TO THE ND OF YEAR 2014, according to numerous Sr mgt comments and public commentary by the higher ups in the company, LOL !!!!!
MY CALENDAR SAYS IT'S DAYS FROM Sept of 2015, NOT end of 2014- and NO, NO PHASE 2 has started. AND NO, it's not "already started" LOL !!! Pure conjecture- the company would have made it public if they finally started a trial now almost ONE YEAR LATE, LOL. They'd PR that till the cows came home- the way this outfit works.
TOTAL NONSENSE IMO to implicate the now nearly ONE YEAR LATE trial has already started.
Lanza speaking to a local MA newspaper, LAST YEAR, in 2014, when this little micro-cap company was still known as ole ACTC (LOL, you know the big "makeover" and the "eye" rebranding thingy hadn't even happened yet)
http://www.telegram.com/article/20141014/NEWS/310149525&Template=printart
Quote: (Posted Oct. 14, 2014 by By Lisa Eckelbecker TELEGRAM & GAZETTE STAFF)
"By Lisa Eckelbecker TELEGRAM & GAZETTE STAFF
Posted Oct. 14, 2014 at 8:10 PM
Updated Oct 14, 2014 at 9:30 PM
MARLBORO — An experimental eye treatment produced from embryonic stem cells was safe for patients and may have helped some regain lost vision, according to a study from researchers affiliated with Advanced Cell Technology Inc.
..............
"We would've expected for most of the patients for the disease process to have progressed," said Dr. Robert P. Lanza, Advanced Cell chief scientific officer. "But what was the surprise was to see so much notable improvement in the vision. That was really unexpected."
The study was too small to show a statistically significant impact from Advanced Cell's treatment. But Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine in Winston-Salem, North Carolina, wrote separately in The Lancet that the work was a "major accomplishment."
Advanced Cell is a small biotechnology company using embryonic stem cells to generate other cells for medical treatments. The company has struggled financially for years while slowly pushing forward in a controversial field.
The Lancet's release of the study came the same day Advanced Cell filed a shelf registration statement with the Securities and Exchange Commission for the sale of up to $100 million in stock or other securities.
Advanced Cell stock, which trades over the counter, rose about 17 percent Tuesday to close at $7.97 a share.
..............
Advanced Cell now hopes to launch a 100-patient, phase 2 study in Stargardt's patients by the end of the year, according to Dr. Lanza.
A second, smaller phase 2 study in patients with age-related macular degeneration would follow, he said. Any treatment might not be ready for FDA approval until 2020, Dr. Lanza said."
"
That ole END OF THE YEAR quote by Lanza, THAT MEANT END OF 2014, LOL!! NOT the end of 2015, which would be now close to ONE YEAR LATE. Their track record of hitting dates- is about as good as throwing darts at a board of random choices IMO.
And $7.97 a share cited in the article- the GOOD OLE DAYS, LOL !!! Now they got their big ole "new name" and on the "Nasdaq" and all- and the price is HALF THAT, LOL !!! What an accomplishment- amazing. A few more big "news" announcements and heck, they might be back under $1 buck at the rate they're "progressing", LOL !! "Hopes to START by end of year" was in 2014, NOT 2015. ANY treatment "might" (sounds real convincing, right?) might not be ready till 2020, FIVE LONG YEARS FROM NOW.
Yeah- it's all just a hop, skip and a jump ole slam dunk, sure thing. A little test here, a $100 million there, everything works perfectly in phase II, where MOST TRIALS FAIL, the ole FDA just approves it all like magic- and it sails on to the imaginary $100 price, no I think it was actually $4,000 supposedly by then, LOL !! Right on.
http://www.nature.com/news/stem-cells-pass-safety-test-in-vision-loss-trial-1.17451
Lanza says "CAUTION" in highly respected journal "NATURE". Peer review commentary in same article says sample size TOO SMALL to yet be meaningful- doesn't sound like any "slam-dunk" ole "done deal" yet to me??????
Quote:
"The VERBATIM article, again, from the highly respected science journal, "NATURE"-
"A company that has spent more than 20 years trying to develop treatments based on embryonic stem cells is taking encouragement from small, preliminary tests of the cells in people with progressive vision loss. If the technique continues to impress in larger trials designed to assess its effectiveness, it could become the first therapy derived from embryonic stem cells to reach the market.
A study of four patients, published in Stem Cell Reports on 30 April1, shows that injection of retinal cells derived from stem cells is safe for people with macular degeneration. The report follows similar results from a trial in 18 patients that was published last October2.
Both studies were meant to assess safety only, and neither included a control group. In the latest study, conducted by researchers in Korea and the United States, three participants were able to read 9–19 more letters further on an eye chart a year after treatment — but two of the three also gained some ground in their untreated eyes."
MORE...
"“This bodes well,” says Robert Lanza, chief scientific officer at Ocata Therapeutics in Marlborough, Massachusetts, and an author of the study. “But I think we need to interpret this improvement cautiously until more controlled studies are done.”
The sample size is too small to warrant much excitement, cautions ophthalmologist Tien Yin Wong of the Singapore National Eye Centre. “At this stage it’s hard to say if the visual improvement will be sustained,” he says. “But it’s very promising.”
"
Ah, the ole UNTREATED EYE gained ground too "problem"?? THAT is where the big ole phase II's, the much more complicated, much broader patient cross-section, the ole control arm, the trials with a placebo arm can trip something like these micro tiny phase I's up every single time. The untreated eye showed improvement TOO?? Well SHAZAM, whata ya know? And a peer commentator- the SAMPLE SIZE IS TOO SMALL to "warrant much excitement"- SHAZAM again. Phase I micro trials are famous for this "problem"- it's common sense. What can one really know about a cross section of human beings when 18 or so people are involved and the company itself ran and controlled the entire "trial"- it's always the problem in the phase I stage. It's why most of the "promising" trials- if and when they fail, they fail big in the phase II portion. It's magnitudes harder than the tiny phase I's to pass the criteria.
If it hasn't already!!!"
WHAT???????? Based on WHAT FACTS????????
The phase 2 WAS (as in PAST TENSE, as in LATE NOW) SUPPOSEDLY GOING TO START PRIOR TO THE ND OF YEAR 2014, according to numerous Sr mgt comments and public commentary by the higher ups in the company, LOL !!!!!
MY CALENDAR SAYS IT'S DAYS FROM Sept of 2015, NOT end of 2014- and NO, NO PHASE 2 has started. AND NO, it's not "already started" LOL !!! Pure conjecture- the company would have made it public if they finally started a trial now almost ONE YEAR LATE, LOL. They'd PR that till the cows came home- the way this outfit works.
TOTAL NONSENSE IMO to implicate the now nearly ONE YEAR LATE trial has already started.
Lanza speaking to a local MA newspaper, LAST YEAR, in 2014, when this little micro-cap company was still known as ole ACTC (LOL, you know the big "makeover" and the "eye" rebranding thingy hadn't even happened yet)
http://www.telegram.com/article/20141014/NEWS/310149525&Template=printart
Quote: (Posted Oct. 14, 2014 by By Lisa Eckelbecker TELEGRAM & GAZETTE STAFF)
"By Lisa Eckelbecker TELEGRAM & GAZETTE STAFF
Posted Oct. 14, 2014 at 8:10 PM
Updated Oct 14, 2014 at 9:30 PM
MARLBORO — An experimental eye treatment produced from embryonic stem cells was safe for patients and may have helped some regain lost vision, according to a study from researchers affiliated with Advanced Cell Technology Inc.
..............
"We would've expected for most of the patients for the disease process to have progressed," said Dr. Robert P. Lanza, Advanced Cell chief scientific officer. "But what was the surprise was to see so much notable improvement in the vision. That was really unexpected."
The study was too small to show a statistically significant impact from Advanced Cell's treatment. But Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine in Winston-Salem, North Carolina, wrote separately in The Lancet that the work was a "major accomplishment."
Advanced Cell is a small biotechnology company using embryonic stem cells to generate other cells for medical treatments. The company has struggled financially for years while slowly pushing forward in a controversial field.
The Lancet's release of the study came the same day Advanced Cell filed a shelf registration statement with the Securities and Exchange Commission for the sale of up to $100 million in stock or other securities.
Advanced Cell stock, which trades over the counter, rose about 17 percent Tuesday to close at $7.97 a share.
..............
Advanced Cell now hopes to launch a 100-patient, phase 2 study in Stargardt's patients by the end of the year, according to Dr. Lanza.
A second, smaller phase 2 study in patients with age-related macular degeneration would follow, he said. Any treatment might not be ready for FDA approval until 2020, Dr. Lanza said."
"
That ole END OF THE YEAR quote by Lanza, THAT MEANT END OF 2014, LOL!! NOT the end of 2015, which would be now close to ONE YEAR LATE. Their track record of hitting dates- is about as good as throwing darts at a board of random choices IMO.
And $7.97 a share cited in the article- the GOOD OLE DAYS, LOL !!! Now they got their big ole "new name" and on the "Nasdaq" and all- and the price is HALF THAT, LOL !!! What an accomplishment- amazing. A few more big "news" announcements and heck, they might be back under $1 buck at the rate they're "progressing", LOL !! "Hopes to START by end of year" was in 2014, NOT 2015. ANY treatment "might" (sounds real convincing, right?) might not be ready till 2020, FIVE LONG YEARS FROM NOW.
Yeah- it's all just a hop, skip and a jump ole slam dunk, sure thing. A little test here, a $100 million there, everything works perfectly in phase II, where MOST TRIALS FAIL, the ole FDA just approves it all like magic- and it sails on to the imaginary $100 price, no I think it was actually $4,000 supposedly by then, LOL !! Right on.
http://www.nature.com/news/stem-cells-pass-safety-test-in-vision-loss-trial-1.17451
Lanza says "CAUTION" in highly respected journal "NATURE". Peer review commentary in same article says sample size TOO SMALL to yet be meaningful- doesn't sound like any "slam-dunk" ole "done deal" yet to me??????
Quote:
"The VERBATIM article, again, from the highly respected science journal, "NATURE"-
"A company that has spent more than 20 years trying to develop treatments based on embryonic stem cells is taking encouragement from small, preliminary tests of the cells in people with progressive vision loss. If the technique continues to impress in larger trials designed to assess its effectiveness, it could become the first therapy derived from embryonic stem cells to reach the market.
A study of four patients, published in Stem Cell Reports on 30 April1, shows that injection of retinal cells derived from stem cells is safe for people with macular degeneration. The report follows similar results from a trial in 18 patients that was published last October2.
Both studies were meant to assess safety only, and neither included a control group. In the latest study, conducted by researchers in Korea and the United States, three participants were able to read 9–19 more letters further on an eye chart a year after treatment — but two of the three also gained some ground in their untreated eyes."
MORE...
"“This bodes well,” says Robert Lanza, chief scientific officer at Ocata Therapeutics in Marlborough, Massachusetts, and an author of the study. “But I think we need to interpret this improvement cautiously until more controlled studies are done.”
The sample size is too small to warrant much excitement, cautions ophthalmologist Tien Yin Wong of the Singapore National Eye Centre. “At this stage it’s hard to say if the visual improvement will be sustained,” he says. “But it’s very promising.”
"
Ah, the ole UNTREATED EYE gained ground too "problem"?? THAT is where the big ole phase II's, the much more complicated, much broader patient cross-section, the ole control arm, the trials with a placebo arm can trip something like these micro tiny phase I's up every single time. The untreated eye showed improvement TOO?? Well SHAZAM, whata ya know? And a peer commentator- the SAMPLE SIZE IS TOO SMALL to "warrant much excitement"- SHAZAM again. Phase I micro trials are famous for this "problem"- it's common sense. What can one really know about a cross section of human beings when 18 or so people are involved and the company itself ran and controlled the entire "trial"- it's always the problem in the phase I stage. It's why most of the "promising" trials- if and when they fail, they fail big in the phase II portion. It's magnitudes harder than the tiny phase I's to pass the criteria.
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