You have been wrong from the outset Allo. Your dribble has become laughable. Mdplanet is correct. Nothing is in the horizon to move this company past it's penny status. Another Israeli company rip-off. With all the news that comes out of this company it is apparent that the institutions realize they have no real pipeline for success. Keep smoking that stuff and your comedy routine will giddy-up...
Good morning MD. I agree with most of your comments. I just don't get what is happening except I don't buy into a secondary if they are using the ATM and if they are again able to get someone to pay for the clinicals. There has been good news and it hasn't been enough to keep the stock afloat. Overall there is a lot of headwind. I do believe the stock will turn and ultimately turn strongly. I just don't think that any reasonable investor would buy into PSTI at the moment given the geo political issues. I know that most of the TASE has done alright for the year. BUT, I have looked into the TASE a little bit and it is not without controversy. I suggest looking at the results from using the search term "Israel's stock exchange: A place where only the rich get richer?" I do wonder about my holding decision. Just a little troubled at the moment. And yes I have noted that while Allo has contributed a lot historically to the board I don't see any objectivity. Most seem to be almost robotic posts of Ally Sue etc.
I agree, he appears delusional and appears to have done little research on Pluristem. He will wish he was from this planet when this stock takes off.
There is a lack of interest in this stock.
There is very little human data to go by.
There is a looming secondary.
There is no catalyst on the immediate horizon.
There is nothing but speculation.
There is an increased cash burn.
There is no word on OD status for preeclampsia almost 6 months later. (If the FDA loved this so much as allo says, then OD would have been granted by now.) It still may come, but now a 5-7% gain means very little at these depressed prices..
There are global concerns running amuck.
What did you guys think? Were you really listening to allo? Shakin' my head.....
Oh, and there is no controller. It's just allo's imaginary friend.
Dude I'm with you this is whack. When even the good news has caused the share price to decline consistently the last six months, it does not make me happy.
"CEO keeps babbling just enough to keep his paycheck" With 142 employees and, let's say, an average salary of $60k...that's $8.5M per year. How is Zami paying these salaries?
This Follows Clearances From U.S., E.U., German, and South Korean Regulators
Pluristem Therapeutics Inc . PSTI -0.35% (tase:PLTR), a leading developer of placenta-based cell therapies, announced today that it has completed the approval process and received final clearance from a fifth regulatory agency for its 3D cell therapy manufacturing processes in use at its new facility in Haifa. The latest approval comes from Israel's Ministry of Health and follows similar clearances from the U.S. Food and Drug Administration, the European Union 's Qualified Person, Germany 's Paul Ehrlich Institute, and the South Korean Ministry of Food and Drug Safety.
"This latest regulatory clearance further validates our proprietary cell manufacturing processes, which we believe are state-of-the-art and unmatched in the cell therapy arena. Our Haifa facility has the capacity to produce approximately 150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value," stated Pluristem CEO Zami Aberman. "This latest approval also exemplifies our strategy of working with multiple regulatory bodies in order to establish Pluristem as a leading developer of cell therapies and to set the standards for this area of manufacturing," added Aberman.
About Pluristem's 3D Manufacturing
Pluristem's state-of-the-art GMP manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which PLX cells can be manufactured in sufficient quantities to support late-phase clinical trials and commercial demand at time of regulatory approval. Pluristem manufactures its products in full compliance with the U.S. Food and Drug Administration (FDA) and European Medicines Agencies (EMA) current Good Manufacturing Practices (cGMP). Pluristem believes that control of the production process is critical for the successful manufacture of cell therapies and invests significantly in developing highly efficient, cutting-edge culturing systems for its range of PLX cell products.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a protein delivery platform that releases a cocktail of therapeutic proteins in response to inflammation or ischemia. PLX cells are grown using the Company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team
Sentiment: Strong Buy
You may be right, as it may be the main reason why the NIH is pouring millions into the human placenta project. It may all come to the surface in the near future.
Is The NIH Already Saving Lives With PLX Cells ??? Maybe !
Sentiment: Strong Buy
Expanded access, sometimes called "compassionate use," is the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options.
FDA regulations allow access to investigational drugs for treatment purposes on a case-by-case basis for an individual patient, or for intermediate-size groups of patients with similar treatment needs who otherwise do not qualify to participate in a clinical trial. They also permit expanded access for large groups of patients who do not have other treatment options available, once more is known about the safety and potential effectiveness of a drug from ongoing or completed clinical trials.
Just as in clinical trials, these investigational drugs have not yet been approved by the FDA as safe and effective. They may be effective in the treatment of a condition, or they may not. They also may have unexpected serious side effects. It is important for you to consider the possible risks if you are interested in seeking access to an investigational drug.
Can any individual patient qualify for expanded access to any drug?
No. In order for a patient to gain access to an investigational drug outside of a clinical trial, the patient must have a serious or immediately life-threatening disease or condition and no comparable or satisfactory therapeutic alternatives. Additionally, the drug manufacturer and the patient’s doctor must make special arrangements to obtain the drug for the patient. These arrangements must be authorized by the FDA. These safeguards are in place to avoid exposing patients to unnecessary risks.
Manufacturers may not always be willing or able to provide access to a drug outside of their clinical trials. Physicians may not always be able to seek expanded access for patients, depending on a patient’s medical history and the risks associated with taking an investigational drug. The physician must determine that the probable risk from the drug is not greater than the probable risk from the disease. Not all physicians are willing to manage the use of an investigational drug for patients in their care.
Companies are not required to make their drug available through expanded access, or to make more of a drug for that purpose. Companies manufacture investigational drugs for the purpose of testing them in clinical trials, since that is the most effective and efficient way to determine whether the drugs work, and whether they are safe to use. Once the drug is FDA-approved, it may be marketed and made more widely available.
Sometimes, even when an expanded access program has been established, there may not be enough of a drug available for all patients requesting access. Some companies establish lotteries to determine which patients will have treatment access, while others make the determination on a case-by-case basis.
Are there costs associated with expanded access?
Investigational drugs are expensive to manufacture. Some companies provide the drug for free to patients. Other companies charge patients costs associated with the manufacture of the drug. Most insurance companies will not pay for access to an investigational drug. In addition, there may be additional costs associated with administration and monitoring of the investigational drug by healthcare professionals.
Am I protected from risks?
When a drug is investigational, federal law requires that its use be reviewed by an Institutional Review Board (IRB) to protect the individuals receiving the drug, including assuring that, in general, the risks are reasonable in light of the potential benefit. However, there may be significant unknown risks. The IRB will require and review an informed consent document to ensure that patients are aware of potential risks and are willing to accept the level of possible risk associated with the drug.
How can I find out whether I can access a particular investigational drug outside of a clinical trial?
Some companies have established expanded access programs. You can use ClinicalTrials.gov1 to view a list of expanded access studies2 on the web, or search for specific expanded access programs, or you or your healthcare provider can call a drug company directly to inquire about their policies. Patient advocacy groups can sometimes help patients find and explore expanded access options.
If you are interested in seeking expanded access to a particular drug, talk with your healthcare professional to see if it might be a reasonable option for you.
Your and your healthcare professional can contact the Office of Special Health Issues3 for information and assistance.
Additional information for healthcare professionals can be found at Physician Request for a Individual Patient IND for Compassionate or Emergency Use4., and at IND Applications for Clinical Treatment: Treatment of a Single Patient in Emergency Setting5. For more information specific to biologics, contact the Consumer Affairs Branch at the Center for Biologics Evaluation and Research at ((800) 835-4709, or (240) 402-8010, or via email at email@example.com.
Information is also available about expanded access to unapproved medical devices6, explaining emergency use, single patient/small group access, treatment use, and continued access after a controlled clinical trial under an Investigational Device Exemption (IDE) has been completed.
Sentiment: Strong Buy