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.
yep. Buteo & allo are the same people. BTW, it's not only a 52 weak low, but a 3 year low as well.
It sure is. It seems to have a bigger effect than just gaining patents or being in "discussions." Maybe someday.....
Perhaps a SAFETY study on HUMANS may be necessary. But then again, I'm ignorant because there is NO evidence PLX-R18 is safe in human use.
elbit, I respect you more than most posters here, but the fact remains, until we have results, the rest is rhetoric. Conversations are a beginning, but still leave us in the conception phase. This PR was Pluristem telling us they have met with the EMA to discuss the protocol. Nothing else.
Vague, yes, as Zami is only saying they've met. Ambiguous, yes again, as the protocol has not yet been accepted. Even more annoying are Zami's statements about other indications. He is so full of nonsense, it makes my stomach turn. Take an indication, forge ahead, then you can begin talking hope and potentials. Right now, we stand with a United trial of 9 patients at a standstill, an IC trial that can't fulfill enrollment, a CEO who touts gibberish and a burn rate far too high for only having to pay for one PH2 trial.
I really don't want to be negative, but I look at truths.
"The study demonstrated mechanisms by which PLX cells and other mesenchymal stromal cells (MSC) influence the immune system in order to modulate immune reactions and to prevent immune reactions against the cells when they are administered as an off-the-shelf product (unmatched). It was demonstrated IN VITRO that MSC, and in particular PLX cells........"
These were in vitro studies. Where are the human results? This stock will continue to slide because the human factor has yet to be proven. If and when it does, then we can see some upside.
Also, please be aware the article was co-authored by Pluristem.
Read the effin animal rule! How can anyone apply a therapy if it is UNSAFE. PLX-R18 must have proven safety trials on humans, whether this trial is for ARS or another indication. The cells must be safe in order to gain approval. PLX-R18 has yet to be injected in any human patient.
Really kgjie? What do you expect us to do? Buy 100,000 shares to drive the price up? Rule #1: Don't get too heavily involved in one biotech. Spread it out amongst many and your chances for success increase incrementally. Rule #2: Don't believe all the hype presented on the message boards.
Dude....profitability can't come without approval. A licensing deal is a one time shot, with milestones along the way. They've already burned through all the cash from the United deal and are still not profitable.
Elbit: This is a PH2 clinical development company. No indication has actually even completed PH2. So, to answer your question, a PH3 trial will take at least 2 years to complete and another year for FDA approval. I personally don't see any marketing authorization for another 3 years, plus. Even with the EMA Accelerated Pathway, they first need to start the PH2 CLI trial. The best we can hope for at this time is positive results, marketing is a long way off.