LOL quote what?, "RPE Therapy Works! Creative Destruction, InProgress, Of Eylea! "
RED, heading for barely $6 and maybe a test of the $5's, cause you know, "IT WORKS" supposedly, LOL.
Well, it seems that "the market" must not have gotten that memo about that myth yet? Also, OCAT Sr mgt must not of gotten it either per their own public statements and the signed statements they made in their own recently SEC filed 10-Q? Cause THEY SAY they need a LOT MORE MONEY for a LOT MORE TESTING and a LOT MORE CLINICAL TRIALS and a LOT MORE TIME (as in YEARS) so they can "try" and "prove" that what they call their "product candidates" (NOT "products" yet, but "candidates) so they can "try" and PROVE THEY "WORK", as nothing has been "proven" yet about anything.
If this myth is true that this just all "works"- then why waste another $100 MILLION plus and YEARS to conduct a large phase II trial and then eventually, possibly (if they don't fail in phase II) - why then an even larger and more expensive Phase III trial(s) to "try" and PROVE THIS WORKS? Why do that? Why not just sell this mythological product/treatment today if it "WORKS" as stated? Why spend boatloads of money and waste years of time if it all just "works"??? Why? Why do that?
From the highly respected science journal NATURE:
www.nature.com/news/stem-cells-pass-safety-test-in-vision-loss-trial-1.17451
Lanza doesn't say "IT WORKS"??? He says CAUTION and MORE TESTING NEEDED to "prove" anything? He didn't dispute or retract or question the NATURE article? Why? He DOES NOT EVER SAY "it works" - he says MORE TESTING NEEDED, lots more testing and lots more MONEY.
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.”
Lanza speaking to a local MA newspaper-
www.telegram.com/article/20141014/NEWS/310149525&Template=printart
"We treated the last UK patients last month, and they also have not seen any safety issues related to the transplanted tissues themselves, either," Dr. Lanza said.
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."
THOSE are the "FACTS" as Lanza has stated um "on the record"- not the other myths that this is a DONE DEAL and SLAM DUNK and already "proven" to work, blah, blah, blah.
That was dated Oct 14, 2014 and the END OF YEAR phase II DID NOT HAPPEN.
Where's the BIG MONEY? Why don't they ever attract any large capital investments- especially any "high quality" money (non dilutive) or at least not cash-for-dilution-shares deals with discounts and all the rest attached to them? Why? Why is that? Why? They live on low grade dilution money and have NO WHERE NEAR the funds to get a large Phase II even started- let alone funded to completion? Why? Why is that?
It took like FIVE YEARS to get a micro sized phase I done. They've yet to even start the large and magnitudes more difficult and magnitudes more expensive Phase II trials (with control arms and placebo blinding)- why? If the phase I took about FIVE YEARS, then how long will these phase II trials take- the one(s) that were supposedly going to be fully funded and rocking and rolling by END OF 2014 and it's now almost half way through 2015 and the trial(s) are in the parking space, going nowhere and the latest Lincoln cash is dwindling down at an alarming rate. Why? Why is that?
www.sec.gov/Archives/edgar/data/1140098/000101968715001797/ocata_10q-033115.htm
Just filed OCAT 10-Q, PAGE 13:
"Our ability to become profitable depends upon our ability to generate revenue. We do not anticipate generating revenues from product sales for the foreseeable future, if ever. "
PAGE 7:
"The Company has no therapeutic products currently available for sale and does not expect to have any therapeutic products commercially available for sale for a period of years, if at all. These factors indicate that the Company’s ability to continue research and development activities is dependent upon the ability of management to obtain additional financing as required."
PAGE 7:
"The accompanying consolidated financial statements have been prepared in conformity with GAAP which contemplate continuation of the Company as a going concern. However, as of March 31, 2015, the Company has an accumulated deficit of $356.2 million, recurring losses from operations, and negative working capital which raise substantial doubt about the ability of the Company to continue as a going concern. The ability to continue as a going concern is dependent upon many factors, including the Company’s ability to raise additional capital in a timely manner. The Company has no expectation of generating any meaningful revenues from our product candidates for a substantial period of time and must rely on raising funds in capital transactions to finance our research and development programs. Our future cash requirements will depend on many factors, including the pace and scope of our research and development programs, the costs involved in filing, prosecuting and enforcing patents, and other costs associated with commercializing our potential products. Accordingly, management’s plans to continue as a going concern contemplate raising additional capital including the prior execution of an agreement for a $30 million equity line in late June 2014, of which approximately $12.5 million remains available as of March 31, 2015. There can be no assurances that management can raise the necessary additional capital on favorable terms or at all. The accompanying financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern."
PAGE 24:
"We cannot assure you that public or private financing or grants will be available on acceptable terms, if at all. Several factors will affect our ability to raise additional funding, including, but not limited to, the volatility of our common stock and the broader public equity market, especially public equities issued by other pre-commercial biotechnology companies, and our ability to raise capital through non-dilutive transactions such as out-licenses. If we are unable to raise additional funds, we will be forced to either scale back our business efforts or curtail our business activities entirely. As of March 31, 2015, the Company has an accumulated deficit of $356.2 million, recurring losses from operations, and negative working capital which raise substantial doubt about the ability of the Company to continue as a going concern.
"
Most recent filed 10-K, PAGE 16:
"
Other than our arrangement with Lincoln Park, we have no sources of debt or equity capital committed for funding. Recent attempts to raise capital in the public equity markets have proven unsuccessful, and we can provide no assurance that we will be successful in any future funding effort. The timing and degree of any future capital requirements will depend on many factors, including:
"
Same 10-K, PAGE 16:
"We will require substantial additional resources to fund our operations and to develop our product candidates. If we cannot find additional capital resources, we will have difficulty in operating as a going concern and growing our business."
Same 10-K, PAGE 16:
"Our independent auditor’s report for the fiscal year ended December 31, 2014 includes an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.
Due to the uncertainty of our ability to meet our current operating and capital expenses, in their report on our audited annual financial statements as of and for the year ended December 31, 2014, our independent auditors included an explanatory paragraph regarding concerns about our ability to continue as a going concern. Recurring losses from operations raise substantial doubt about our ability to continue as a going concern. If we are unable to continue as a going concern, we might have to liquidate our assets and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements. In addition, the inclusion of an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern and our lack of cash resources may materially adversely affect our share price and our ability to raise new capital or to enter into critical contractual relations with third parties."
Same 10-K, PAGE 46:
"We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheet of Ocata Therapeutics, Inc. and Subsidiary as of December 31, 2014, and the related consolidated statements of operations, stockholders' deficit, and cash flows for the year then ended and our report dated March 16, 2015 expressed an unqualified opinion thereon and included an emphasis of a matter paragraph relating to an uncertainty as to the Company’s ability to continue as a going concern.
/s/ BDO USA, LLP
Boston, Massachusetts
March 16, 2015"
"
But the myth is, that it all supposedly "JUST WORKS"??? LOL !
