REALITY quotes- YEARS, IF EVER and it's $3 a share now:
All quoted from various sources that interviewed a member of Sr Mgt (such as a local MA newspaper for example) or cited a Sr Mgt presentation, or used direct quotes from the company's own SEC 10-Q/10-K filings etc
" "The use of human embryonic stem cells as a therapy is an emerging area of medicine, and it is not known what clinical trials will be required by the U.S. Food and Drug Administration, or FDA, in order to gain marketing approval. Costs to complete could vary substantially ..."
05/07/15 10-Q
Research and Development Expenses
(excerpt)
We believe that it is not possible at this stage to provide a meaningful estimate of the total cost to complete our ongoing projects and bring any proposed products to market. The use of human embryonic stem cells as a therapy is an emerging area of medicine, and it is not known what clinical trials will be required by the U.S. Food and Drug Administration, or FDA, in order to gain marketing approval. Costs to complete could vary substantially depending upon the projects selected for development, the number of clinical trials required and the number of patients needed for each study. It is possible that the completion of these studies could be delayed for a variety of reasons, including difficulties in enrolling patients, delays in manufacturing, incomplete or inconsistent data from the pre-clinical or clinical trials, and difficulties evaluating the trial results. Any delay in completion of a trial would increase the cost of that trial, which would harm our results of operations. Due to these uncertainties, we cannot reasonably estimate the size, nature or timing of the costs to complete, or the amount or timing of the net cash inflows from, our current activities. Until we obtain further relevant pre-clinical and clinical data, we will not be able to estimate our future expenses related to these programs or when, if ever, and to what extent we will receive cash inflows from resulting products."
Atala: "Much work remains to be done before hESC and induced pluripotent stem cell therapies go beyond regulatory trials,...."
The Lancet, October 14, 2014
Comment/Anthony Atala
Wake Forest Institute for Regenerative Medicine, Wake Forest
University School of Medicine, Winston-Salem, NC 27157, USA
Human stem cell-derived retinal cells for macular diseases
(excerpt)
Much work remains to be done before hESC and induced pluripotent stem cell therapies go beyond regulatory trials, but the path is now set in motion.
"....market potentially as early as 2019. "
Press Release
February 26, 2015
Ocata Therapeutics Approved for Listing on NASDAQ
(excerpt)
The purpose of the pivotal SMD trial is to determine efficacy and safety, as well as to assess relevant functional and anatomical parameters of cell transplantation using an untreated control group, with the intent of bringing a product to market potentially as early as 2019.
Wotton: "Over in Europe we believe we might be able to get that product to market towards the end of 2018, but we are targeting 2019."
YouTube
Dauphin Investor
Roadshow: Ocata Therapeutics, Inc. (IPO)
Published on Dec 6, 2014
Lanza: "Any treatment might not be ready for FDA approval until 2020..."
Tuesday, October 14, 2014
Published study shows: ACT treatment restores some sight
By Lisa Eckelbecker TELEGRAM & GAZETTE STAFF
(excerpt)
"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.
Schwartz: "It's not ready. Maybe in a few years. Maybe not. We have to wait and see. The jury is way out still."
npr
Embryonic Stem Cells Restore Vision In Preliminary Human Test
Rob Stein
October 14, 2014
(excerpt)
For his part, Schwartz says he's just trying to help blind people see better. But he cautions that this work is still at a very early stage. "I don't want patients to come in to their doctor saying, 'Hey, I heard about the stem cells on the radio and I'd really like to get that treatment done, and what do you think?' " he says. "It's not ready. Maybe in a few years. Maybe not. We have to wait and see. The jury is way out still."
EVERYTHING they state is laced with words like "we hope" or "we think" or "potentially" or "with the intent" or "we're targeting" or "not known" or "impossible to estimate" or "maybe 2019 or maybe 2020" or "the jury is still way out" or "it's impossible to know" and on and on and on. THEY DO NOT KNOW how much cash they will need and they DO NOT KNOW if they will even pass a Phase II or even complete one- it's as simple as that IMO.
This is NO SLAM DUNK, "they're really close to a PRODUCT TO SELL" LOL !!! WHERE, WHERE has the company itself EVER said any words even remotely close to that- versus some "stem cell blog" being the ONLY source of those false claims??? The company says in plain English "WE DO NOT KNOW" and we "HAVE NO DATE" other than a "possibly-maybe WAG/guess of possibly/maybe/might-be FOUR or FIVE years from now", LOL!!
WHAT if the stock market collapses 50% and the capital markets go DRY in say year two of that future FIVE YEAR guesstimate- then where will they be? The continual "claims" that this thing is "ALMOST A DONE DEAL" or even remotely "close" to the end of a massive and expensive regulatory gauntlet they must run to the finish line- are JUST PLAIN 100% FALSE IMO. Total NONSENSE.
THAT is the "real" story IMO- YEARS, "IF EVER" to an actual "product" AND they DO NOT KNOW what it will "cost" - and only have a measly $30 million or so now (dwindling rapidly with each passing day/week/month) AND statistically most drug candidates FAIL in the Phase II by well published industry wide norms (A simple Google search will reveal numerous academic and industry "think tank" and journalism sources such as Forbes discussing the massive failure rates of Phase II clinical trials). The U.S. and global markets appear to be facing the end of the "bull" run and capital markets are tightening and drying up- right as this OCATA thing will need mountains more cash and use of dilution for years to come for survival. NOT GOOD IMO. This is in pure lotto odds gambling territory IMO.
Their common shares are their only "currency" they have (aka dilute, dilute, dilute) - so the lower their common share price collapses, the more high risk of mass failure the company gets IMO. And the concept that "investing" is waiting/expecting some large, magic like price "POP" simply because they got it to "POP" a few times in the past- well, again is nothing but akin to gambling. The 5 year chart of this thing is a mass train wreck and story of DEAD MONEY through probably the greatest bull market in all of world history.
An occasional "POP" in share price every few years- hardly makes this an "investment" and just cause it "popped" a certain percentage years ago- is certainly NO guarantee a similar "pop" will happen now in a totally different market environment and on the much tougher Nasdaq IMO.
REALITY IMO, nearly every common shareholder has been wiped for massive, massive losses by this company- the chart would make it impossible for one to prove otherwise IMO and for one to have perfectly timed and gotten out at any of the few micro pops- most, literally lasting minutes to a single day or two at most- yet the ever revolving door of "C" level insiders have literally self-enriched themselves to $MILLIONAIRE status as the common shares have never produced so much as ONE CENT of ROI and were diluted out to now the equivalent of 4 BILLION plus shares O/S and a literal 3 CENT per share price, when the 100:1 R/S split is backed-out.
IMO, It's about as poor and losing an "investment" to exist anywhere in penny-ville. Probably their only real "accomplishment" I can find, is they never actually went sub penny, LOL !!! Other than that- what else have they really ever done of value to an actual "investor"????? What?
My $3 bucks or so worth- barely the price of a decent Sunday morning cup of good coffee.
AI
