Timeline for approval:
Trial Protocol: No less than 2 months for the trial design.
EMA Trial Protocol Approval: Up to six months after trial design.
Trial initiation: More time to establish trial sites.
Trail: Enrollment fulfillment up to 3 years based upon past/recent progress. with IC.
Safety Study: At least 12 months after initial dosing.
Completion of said trial: more than 3 years.
PLX-R18: they need to start a HUMAN trial then receive HUMAN safety results in order to get approval for ARS. Since there is no HUMAN trial started, this is at least 2 years away.
Sorry folks, but the truth is what it is.
Because Zami wants to save his job. With the vote Tuesday, he is securing his position with his Israeli cronies. He has no support in the US. Sidestepping the real issues like why the IC trial is taking so long? The most advanced therapy is being overshadowed with more lip service.
Even more frustration stems from the fact that this is the most advanced indication yet Zami continues to tout new trials for others. What's worse is the timelines keep getting pushed back. What was 1H2015 is now in the next 12 months.
Today's letter is more gibberish, "anticipations" and "potentials." Everyone wonders why the price hasn't moved with the recent EMA news? The fact remains they haven't even submitted the study protocol for the trial. We are still years away from ANY type of commercialization. Adaptive Pathways means nothing without trial results.
A very appropriate time to hold a "conference." Gee, let's schedule this for when the NASDAQ is closed. SMH
Hey cal. Thanks for the compliment but it is unwarranted. It really is a quandary to me why we don't see more major players getting on board. The Oppenheimer accumulation is a positive, but otherwise we are missing many of the big biotech names. There is still some reporting left, so we will see. I'm not confident, though. 1.74% ownership is a joke.
You mentioned management and the stock value. I believe they could improve their credibility by completing the IC trial and focusing all their efforts there. This indication is the furthest along. This is a PH2 trial which would qualify for conditional approval if it's a success. All else is nonsense coming from an untrustworthy CEO. . Zami needs to follow through for once, then we can begin to see some value.
We are quickly approaching 2H2015 and his promises continue to be unfulfilled..
When the "tutes" have real stakes in the company, then you can brag. I'm looking for millions of shares, not thousands.
go to SEC website then do a FULL TEXT SEARCH and type in Pluristem Every form that contains "Pluristem" will appear including the 13-F's. When you see the report you want. click "Index" and that will take you to the filing detail page where you want to look at the table. 2 minutes.
Please provide a link or some back up. I didn't find anything to support your statement including the NASDAQ site, MSN Money or the Riggs website.
So, it looks as if they didn't find a partner despite all the speculation. Wainwright had stated the company didn't want to go it alone for this indication, yet here we are.
I hope you all voted Zami out. He's useless as a CEO.
Be careful listening too much to allo. He and his cellmates have been saying the same things for years. Do your own research. You will find the company says (and has been saying) they "are at least three years away" from commercialization. His only usefulness is the articles he finds, but even some of those are not directly relevant to the company.
PLX-R18.has NEVER once been injected in a human being in a clinical trial setting. There is no HUMAN SAFETY DATA for this formulation. The primate tests are for efficacy only. We really can't irradiate people. If the current studies are successes, we become one step closer, but not by the end of the year. We must still pass a safety test that will most likely require a 1 year follow up.
If this were PLX-PAD instead, for example, we would have safety data from other indications and once the primate studies were complete, then approval would come. But since PLX-R18 cells have yet to be injected in anyone, we need that information.
A successful efficacy trial with these primates would be a nice catalyst, though.
Quarter Ending 12-31-2010: 26,489,904 shares.
Quarter Ending 12-31-2011: 44,117,044 shares.
Quarter Ending 12-31-2014: 70,494,863 shares.
All figures are from the 10-Q's found on the SEC website. If you really want to see some interesting numbers, look at the report dated 2-9-2011. There you will find charts listing the shares from as far back as 2003, when, at the end of June, there were only 109,655 shares and Quarter Ending 6-30-2007 amounted to 4,954,110 shares after the secondary of 3,126,177 shares.
The new report will be out in a few days. watch for it because Zami won't tell you when nor will he ever host a CC. History shows on the 8th, but this year it's a Friday. Expect them the 7th or 11th. keep an eye on the cash, it will be closing in around $35M. That equates to about 6 quarters provided the burn rate doesn't increase.
However, as they intend to start new trials this year (so says Zami's lip service) it's highly plausible more cash will flow out the door and quite predictable dilution isn't that far off.
Allo: These are the facts, Jack.
From the Wainwright report dated 2/18/15.
"Clinical Development of PLX-PAD
1. Based on our conversation with management, the randomized, double-blind, placebo-controlled Phase 2 trial in IC has enrolled more than 60 patients at 23 sites in the US, Germany, Israel, and South Korea, and targets to enroll a total of 150 patients."
From the Wainwright report dated 11/11/14:
"Clinical Development of PLX-PAD
1. Based on our conversation with management, the randomized, double-blind, placebo-controlled Phase 2 trial in IC has enrolled approximately 60 patients at 19 sites in the US, Germany, Israel, and South Korea, and targets to enroll an additional 90."
It doesn't seem to be progressing very rapidly.
Pluristem first needs to complete enrollment in the IC trial. 3 years and less than half fulfilled. Why is that?
According to one of the most recent analyst reports, they will have ~$31M at the end of the current quarter. That should give a hint as to what will happen with the shelf.
In response to your post below kgjie, yes, they have a vote every year. Last year. Zami received more "nay" votes than any other board member. Around 2.5-3M (15-20%) from memory but you can check the SEC website for the exact amount. Unfortunately, there are no major shareholders to vote him out. He's a disastrous CEO and his lackey Yaki could go as well. Cronies from a previous company, two peas in a pod. No good.