There are no human data for PLX-R18.
Exactly. Thank you.
Yea or Nay for the Current Board? Let's hear some intelligent thought on this.
Stop misleading people. A human safety trial is required before it can be approved.
When we see human results, then I will back your statements. Until that time, all else is hype generated through preclinical therapies that don't much matter. The human factor is what counts, period.
On another note, with all these new institutional holders, I wouldn't be surprised to see Zami & his lackey Yaky get the boot at the next shareholder meeting. That would probably be the best thing for this company.
Hey cal. I'm here, but unfortunately there hasn't been much to say. The only tangible positive has been the increase in institutional holdings. Otherwise, the company continues to release fluff while we await the completion of the IC trial. On the ARS front, we're looking pretty good but again it's a waiting game for the initiation of the PH1 human safety trial for PLX-R18.
To me, it seems the company is having a hard time moving forward. For whatever reasons, they still have not started any new trials despite all the hype they created, especially on the CLI front. I also question why there isn't any progress with the orthopedic indications.
It's been frustrating but hopefully things will pan out. Meanwhile, I'm just waiting it out like many others here.
So I seems I was right. The Animal Rule does requires human safety testing. I said it all along, but you refused to believe or at least admit it openly. Another classic example of allo providing misleading information.
"When human trials are not ethical or feasible, as in this indication, the FDA’s Animal Rule regulatory pathway allows for the determination of the efficacy of drugs using animal efficacy studies and human safety data."
There is no human safety data for PLX-R18 as of yet.
Allo, your only rebuttal is to use your aliases and give me 5 thumbs down? Go back to your corner and repeat 100 times, "I will not deceive investors."
So few wanted to listen. Use caution, I urged. Don't bet the bank, I said. Listen to reason, I ranted. Keep an eye on the deceitful, I proclaimed. Now, today, we sit in a puddle of mud.
To use a line from snow_tracks: Go in the corner and repeat "human results" 100 times. When you're done with that, go back and repeat 100 more times, "Phase II, Double Blind Trial." You see the point...?
hangons, I don't want get into it too deeply but the fact that NOTHING is happening IS the issue at stake here. ODD holds no significance until the indication has gone through the proper trials. The "agreement" with Japan was nothing more than a satisfactory protocol. The United "agreement" was dissolved and the IC trial has not met its anticipated completion date for enrollment/completion. No 2015 trial initiations as promised.
Need more be said.......
What's questioning to me is why we haven't heard anything about Europe still. They had their "meeting" but no protocol approval?
You see how allo can be deceitful and not completely upfront....
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Hi cal. I hope all is well with you & your group.
A lot of activity surrounds the general biotech markets, especially the smaller ones, as they are victims of a sell off as investors tend to exit their higher risk positions & speculators fear the macroeconomic factors. A shame for us that like to play the high risk/high reward game.
Concerning PSTI & your questions:
1. PSTI has 2 active trials. The United trial seems to have stalled. Why, no one knows. I believe there is more to it than simply slow enrollment as they only need 9 patients to complete it. This could be a major factor in the drastic drop in SP. The IC trial is progressing & we are getting closer to fulfillment, but it still seems to be moving rather slowly. Hopefully by fiscal Q316 we can see some progress. We are still a ways away.
2. My belief is that there was a re-engineering of the cells, hence the name change. If that's the case, they are starting from scratch here.
3. Time to market is longer than some here believe. CLI hasn't even begun. Another 150 patient trail will take at least 3 years to complete then a lag for follow up. IC will need a PH3 in the US so, again, at least 4 years, probably more. ARS, inclusive of animal efficacy testing, will need human safety testing. Again, enrollment completion combined with a 1 year follow puts this at least 2 years away.
4. Zami is all over the board. They have many plans but can't follow up on a single one. Sideways, not forward as I have been saying. They may be progressing slightly, but at a snail's pace & everything is a "possible", "potential", "perhaps", "maybe". "Build it and they will come" is only good in movies.
5. If you can afford a loss & it helps your tax status, then do what's best for you. After 30 days, you can buy back & I personally foresee nothing major happening by years' end. I hope this helps. I do have hopes in the technology, but I refuse to get to heavily invested here until I see a change.
The only things that will move this stock are positive results from human trials. Get it? The rest is hype from a management team unworthy of their positions and their salaries. Keep pumping all they like, but until the IC trial has completed enrollment (over 3 years for 150 patients, pathetic) and the analyses show what we all hope is true, the rest we hear has little significance to the value of the company. We plan to...., shows potential...., have discussed..., may improve..., possible effects..., shows improvement in models..., received patent...etc.. What does all this truly mean when it boils down to the effectiveness of the technology? Show me more than a bunch of preclinical & PH1 trials.
The markets want results, as do I. Enough with the nonsense and move forward, not sideways.
Allo, you are the one who is wrong here. I don't have time to pull up the Animal Rule right now, but it is stated that a safety test must be completed in one way, shape or form before approval. In this case, it does not need to be for ARS (as it can't), but PLX-R18 MUST have safety results in some indication. What you say makes no sense. So the FDA will approve a drug/therapy without a single iota of knowledge on how this drug/therapy reacts to the human body? I'm not saying R18 does, but if a drug/therapy is proven effective in an Animal Rule indication, but then kills the patient two weeks later, what good is it? Drugs need to be safe as well as effective.
Zami is leaving out any statements about safety and is only focusing on efficacy.
PS: I see you pulled out all your aliases for my thumbs downs.
The animal testing is for EFFICACY. There will still need to be human trial with PLX-R18 to determine SAFETY in humans. PERIOD!
This will most likely be the PH-1 bone marrow trial they talk about. Now, the question remains as to when this starts and when it completes.
PLX-R18 will not be approved until it is PROVEN SAFE. Get it?
...and yes, read the Animal rule and you will see it is written there.