Response in the Lancet by Schwartz et al to questions raised on the results presented in the article.
We thank Janet Sunness and Guo-You Zhang and colleagues for their comments on our Article.1 Sunness asserts that transplantation of human embryonic stem cell-derived retinal pigment epithelium (hESC-RPE) into patients with advanced dry age-related macular degeneration and Stargardt's disease needs to be tested. We report only visual improvements as noted during the course of a phase 1 safety trial. As mentioned in our Article,1 many potential explanations are available for these observations other than an actual functional improvement, including those suggested by Sunness. However, the area of the macula transplanted in our patients intentionally excluded the foveal centre to which Sunness refers, and instead targeted a transition zone that included undetectable, compromised, and healthy photoreceptors. This choice of transplant site was guided with multimodal imaging done preoperatively and intended to transplant an area that recapitulated the central macula earlier in the course of the disease. Again, safety was the primary endpoint studied. All vision improvements came as surprise to the investigators. All patient assessments were assessed by masked vision examiners with expertise in low vision rehabilitation.
Perhaps more importantly, accumulating evidence suggests that photoreceptor inner segments or cell bodies might survive in a state that is difficult to detect in some forms of macular degeneration.2 Thus, if biological plausibility of transplanted stem-cell progeny conferring a regenerative signal to neighbouring tissues is discounted, a rescue effect of dormant cell types might still be noted. Therefore, we respectfully disagree with the statement that transplantation of stem-cell-derived retinal pigment epithelium cells cannot restore vision; we are confident that this is an open question and are hopeful that future studies will help answer it.
It's not misleading - it's clear that there are only 4 patients. Call it inconclusive or insignificant if you want but misleading suggests they are trying to hide something.
IPSC RPE sheetThe pioneering induced pluripotent stem cell (IPSC) clinical study in Japan led by top stem cell clinical researcher Dr. Masayo Takahashi has been stopped reports the WSJ in Japan. This development is confirmed by other sources and in a PDF report by RIKEN (in Japanese here).
One patient was transplanted in September 2014 with their own IPSC-derived retinal pigment epithelial cells (using an innovative RPE sheet, see image) for treatment of macular degeneration.
The study then moved on to a possible second patient, whose IPSC did not pass a genomic validation step. Reportedly, these IPSC contained a mutation, potentially in a known oncogene, which is a serious concern. Thus, the team decided to at least temporarily suspend the trial pending a possible redesign. The new plan could involve a change in how the IPSC are produced. For example, the team is reportedly considering the possible use of allogeneic IPSC as well, which could come from CiRA (Center for iPS cell Research and Application, Kyoto University).
Because others may not know that and I don't want stupid statements to gain any legitimacy. The company has enough real problems. Other than that,miss just a hobby.
Wake up keep, I've been pretty clear about the company's problems. I just don't throw a temper tantrum hour after hour and day after day about the same things.
So at least you've admitted that your statement is wrong about the reverse merger.
That's garbage keep. The reverse merger has nothing to do with the current problems. There have been successful reverse mergers.
"Anyway, even if the buyer decides to give us shares of it's stock, ". The buyer doesn't give you anything. If they do a stock purchase they use their existing shares as currency. The value should be nominally they same whether they pay in cash, shares or gum balls.
Not exactly sure what you mean by proportional keep. But in a share exchange with a large cap company rest assured that your OCAT shares would convert into very few shares of say GE since folks love to throw that name around.
It maybe the case that a well funded more experienced company could get a treatment to market sooner - interesting though that none of the larger cap bio techs have tried to the point of trials. But for current owners of OCAT we fair far better if OCAT can bring it to market on its own. This is a long shot but that's what a speculative play is high risk/reward. If I wanted to own GE or some other company I would have bought that stock.
If you buy 100% of a company the prior company's shares cease to exist - they are purchased, that's how you take over ownership. If there was a merger versus a sale you'd get stock in the new entity - plenty of different ways to structure ownership in a merger. A company could buy OCAT with stock, but as I said previously if a large cap company were to buy OCAT they'd likely do so with cash. If a large cap did buy with stock you'd get proportional shares in the acquiring company. Do a quick conversion with any large cap and you see you might get a handful of shares.
Keep, you just don't get how this works. Whether or not the acquiring company creates a separate division of not, they buy the existing company which means they buy your shares. You are done as an owner.
Keep, again I don't get why you want the company sold? Even if it went for double your $2 guesstimate you're investment in this is finished. You'd get $10k and that's that - of course you could buy shares in whatever company bought OCAT, but suffice to say it won't be a pure play on stem cells.
The safety profile emerging from the Phase I/II study supports the recent initiation of the Company's Radiant "Study, a Phase II controlled proof-of-concept trial. The BCVA and CS measurements for the majority of the patients in the study either improved or remained stable in the treated eye. OCT analysis showed increases in central subfield thickness and in macular volume in the treated eye relative to the untreated eye. The prospective analysis of both cohorts in the study showed GA growth rates in the study eye that were lower than those seen in the control eye, consistent with the previously reported interim findings for Cohort I alone. However, to further investigate the possible effect of the cells on GA and to inform future clinical development, the Company subsequently engaged a reading center to perform a separate post-hoc assessment. The separate assessments have revealed greater than anticipated variability in grading of the images. While the prospective analysis for both Cohorts continues to show a decrease in the rate of GA progression in the treated eye for the majority of the patients, the post-hoc analysis did not reveal a similar trend. Further analysis of the collective data is ongoing to determine possible explanations for these findings. "
Rarely does something good follow 'however' or 'but'.
Here's the problem with your thinking keep.
" But to answer your question on why I don't sell now, which should be intuitively obvious to most folks, is if, or when, they are bought by another company, a company that has both the expertise and cash to see the RPE cells through to commercialization, this will cause the stock price rise significantly, due to all the financial institutions who start to buy"
If the company is bought, you as an OCAT shareholder get whatever the acquiring company pays - in your analysis $2 per share. Then you are done. You'd have to own stock in the acquiring company to realize any value in whatever product is brought to market. This company is way to small for any large company to bother with a merger - even then you'd get a fraction of a share in a merger. Merge with another cash starved company and its more of the same.
Why won't you answer the question keep? Just take a guess on what someone would pay for OCAT right now?