Candidates must have completed a Phase 2 trial in order to qualify for conditional approval. PLX-RAD is still pre-clinical.
PSTI will need to finish this pivotal trial if they wish to shift their focus to territories that permit adaptive licensing. Companies need to have a PH2 trial under their belt in order to be considered for conditional approval.
go to the message list. you will see the same title there. click on it and you can still see the thread.
I love how you had to remove the thread from yesterday and replace it with a new one. God forbid people learn the truth. Childish games you play allo.
So, basically you're admitting you can't answer the question. lmao
IC has only enrolled 60 patients of 150, king. It's a long way from being complete. Muscle injury has only been injected into 20 patients. Hardly enough to go on.
But you can't answer my question. You only respond with nonsensical dribble.
Which 2? You really think they would give staggered approval fir a PH 1/2 trial of 20 patients? CLI had 2 Phase 1 trials not a Phase 2. .
And which therapy from Pluristem would be considered. Nothing has completed Phase 2. Years away from anything, Allo.
On June 3, 2013, Zami issued a press release regarding the IC Clinical Hold. In it he said "Out of 74 patients enrolled in Pluristem’s trials to date...".
Let's dissect the numbers. At that time, 27 patients were injected in the CLI trials. In March 2013, it was noted that 6 patients had been injected in the Muscle Injury Trial. From my calculations, that would mean 41 patients would have been injected in the IC trial. Giving the benefit of a doubt that 6 more patients had been injected for the muscle injury trail at the time of the June PR, that would leave 35 patients in the IC trial.
On November 10, 2014, Wainwright updated their report. Here is a quote: "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."
That would mean, at best, only 25 patients have been enrolled since the lift 15 months ago. Not very impressive numbers. I'm not exactly sure they're going to meet their enrollment target date of mid-2015. One must ask themselves why this is taking so long.
Here, here, principalskinner. Nobody else sees there is very little data published. They have yet to complete a pivotal study. 27 patients from 2 PHASE I CLI trails and 20 patients form the hip replacement PHASE 1/2 trial.
Ok, I probably irked a few of you earlier today, but I would like to continue my conversation on Zami's lack of leadership.
Has he been able to capture any investors other than the few million he grabbed from United? I still look for the big biotech investors; Baker Brothers, Deerfield. Orbamed, FMR. None of them seem to want to take part as of yet. You really have to ask yourself why. This is a Phase 2 company with a pipeline, somebody should be on board.
Zami has no experience bringing a biologic product to market, period. He is an engineer from a robotics company and brought along his lackey, Yakay. Hardly the right resume for someone to run an upstart biotech. We hear more about the manufacturing and large scale production potential than we do about any trials. Wall Street is saying show me efficacy and safety before I buy in. You can produce billions of these cells, but if they don't work.... There really is very little human data. The IC trial is the turning point. But yet again, Zami remains silent.
He has promised so much by the end of the year, but in reality, this company is in no better position than it was 12 months ago.
In a nutshell, the guy can't be trusted with a word he says.
I'm going to keep this simple:
allo, et al., work for a PR company hired by Pluristem. This company is also responsible for arranging small media interviews such as DecisionPlus and for assisting in blog posts. Basically it's all hype along with Zami's style. Let's look at Zami's track record.
Let me begin with preeclampsia. That was the cat's meow during Preeclampsia Awareness Month. Pre-clinical results, OD designation, investor conference, steering committee, PH1 by the end of the year. What exactly have we heard since? This is following the path of AA and Beurger's Disease. And the Placenta Project? Show me one article where PSTI was mentioned as an integral player in this. Other than bloggers like Sharon, I can't find a thing.
But then again when does Zami speak to investors? Never once a conference call and only the 1 simulcast. This is another big issue with the guy. To regretfully pull up the incident in 2012, his reaction and rebuttal to the bad PR was an interview with an Israeli newspaper. That doesn't make sense. Talk to the investment world, most CEO's would. Reality is, we still don't know anything about why the second patient died.
In late May of 2012, Zami did have a Bloomberg interview, (which you can still find), soon after the hype of the compassionate use patients. In it, he once again mentioned partnerships as he always does. But more to note, he also talked about cash on hand and how, even without a partner they could go it alone. The stock soon soared, the insiders sold under a "Planned Sell" guise, and in early September came the secondary. Then the cover-up was exposed. Do you really think Wall Street has any respect for the guy?
Said Aberman: We will present the final hip replacement data set later this year.
Said Aberman: We will start rotator cuff trail later this year.
Said Aberman: We will begin PH1 preeclampsia later this year.
Said Aberman: I didn't know about the girl's death, (but he seemed to know about the second patient)
Said Aberman: We have plenty of cash (May 2012 Bloomberg interview, months before the secondary)
Shakin' my head at this so called leader......
he can only delete threads, incessantly post nonsense and annoy everyone with his gibberish.