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Any debate with these facts zzaatt and FDA?
Ok, thanks.
ARK Investments
That's great!!! Maybe, at some point, we will attract Tute's interest above 4%, Like REAL regenerative companies...
But... IF we keep shorting them with the ATM, probably not.
FYI: 24 RMAT
I'm willing to wager if you can handle it...
If your right, I'll stop posting.
If your wrong, You'll stop posting.
Anti Up.
Lior Ravi should be discussing why Buergers Disease and Pre-eclampsia ondications have been shelved to move Mustard Gas Tx forward!!
The Investor Relations Department doesn't seem to respond to Investors.
The fact that 'mustard gas' treatment is now a flagship indication and Pre-eclampsia is dead and buried is a joke right?!?!?! Somebody please say the quarterly report was a practical joke....
It was practical joke, for sure. CRAZY.
Why do we think the DOD would sign a contract when the 'pivitol' studies they want havn't even started?!
What would be the point of the additional studies?!
Um. You said the 'process' is the product so many times already though. Now it's an Art, not science ??
True, very slow leak. Like the titanic.
Sinking like a Roc
Probably who bought the 296,000 shares now underwater.
Divertente, no Barkan
To think that YaYa was/is an Accountant, really makes this a pathetic report. Especially in the 'year of the shareholder'
Thank you so much.
MAY IS PREECLAMPSIA AWARENESS MONTH!!!!
https://www.preeclampsia.org/PreAM
MAY IS PREECLAMPSIA AWARENESS MONTH
Spread the Word in honor of May as Preeclampsia Awareness Month!
As a nationally recognized health observance, Preeclampsia Awareness Month presents the perfect opportunity for the Preeclampsia Foundation to offer education and events that will increase awareness of this life-threatening hypertensive disorder of pregnancy, which occurs in up to eight percent of all pregnancies.
The Preeclampsia Foundation’s theme for the 2016 Preeclampsia Awareness Month is: The Faces of Preeclampsia: Any Woman, Any Pregnancy. Millions of families are unexpectedly affected by preeclampsia each year. Together, we tell their stories and highlight the many impacts that preeclampsia can have on the whole family.
Are you a Face of Preeclampsia? Tell your story and share a photo on our story section this May!
For more educational resources about preeclampsia to share, check out the Preeclampsia Foundation YouTube channel.
Another high-quality communication to shareholders (bag-holders) in this 'Year-Of-The-Shareholder'! When are folks going to demand transparency and accountability?!
Notice the fastest opportunity to revenue (Pre Eclampsia Indication) which was awarded the FIRST ODD, has been seemingly BURIED, no longer mentioned or pursued, despite its improvement for patients where there is no suitable medical solution...
Why should there be any more confidence in the 3 other ODD designations seeing the light of day as Accelerated Review and Approval?
"An FDA Approval Will Never Solve Their Inability To Make Millions Of Doses, In Order To Meet Massive Global Demand."
FDApproved
Tuesday, 09/25/18 01:02:19 PM
Post # of 16101
As you accurately pointed out in a previous post, psti currently cannot mass produce R18 in the quantities to fill even a portion of a stockpiling contract.
And GMP certification at Thermo Fisher could take 2-4 years.
https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM407991.pdf
Funny, please list the items you think are most excellent and directly applicable to medical science, collaborations, partnerships, company sales & bio-pharma-FDA negotiations... you won't though.
Why is this Newsworthy? First Patient treated in trial? Ok, just as likely to have received placebo.
And now we know that the trial is JUST STARTING....... TICK, TOCK, 2020
X2
https://www.bloomberg.com/research/stocks/people/person.asp?personId=2971307&privcapId=6124664
Background*
Mr. Yaky Yanay is the Co-Founder of the EyeCue Vision Technologies Ltd. Mr. Yanay has been Co-Chief Executive Officer of Pluristem Therapeutics Inc. since March 29, 2017 and has been its President since February 4, 2014. Mr. Yanay served as the President and Chief Operating Officer of Pluristem Therapeutics, Inc., (a/k/a Pluristem Life Systems Inc) from February 4, 2014 to March 29, 2017. Mr. Yanay served as Chief Financial Officer and Secretary at Pluristem Therapeutics, Inc from February 05, 2015 to March 29, 2017. He served as the Chief Financial Officer and Company Secretary at Pluristem Therapeutics, Inc. (a/k/a Pluristem Life Systems Inc) since November 1, 2006 until February 05, 2014 and serves as its Principal Accounting Officer. He has been an Executive Vice President at Pluristem Therapeutics, Inc. since March 17, 2013. Mr. Yanay served as Vice President of Finance at Pluristem Therapeutics, Inc. Mr. Yanay served as Vice President of Elbit Vision Systems Ltd., and served as its Secretary since December 2006. He served as the Chief Financial Officer of Elbit Vision Systems Ltd. from July 2002 to December 2006 and served as its Principal Accounting Officer. Mr. Yanay has been Director of Pluristem Therapeutics, Inc. since February 05, 2015. Mr. Yanay has extensive experience in financing and management of technology companies and played a major role in planning and executing a turn around plan of Elbit Vision System, including the completion of three acquisitions and raising more than $20 million. Mr. Yanay began his financial career at Ernst & Young Israel, where he served as Manager of audit groups of the technology sector from 1999 to 2002. He served in the Israeli Ministry of Foreign Affairs since 1993. He has been a Director of Elbit Vision Systems Ltd. from July 2010. He serves as a Director at EyeCue Vision Technologies Ltd. He is a Certified Public Accountant in Israel. Mr. Yanay holds a Bachelor's degree with honor in Business Administration and Accounting from the College of Management Studies in Rishon Le Zion, Israel.
https://www.bloomberg.com/research/stocks/people/person.asp?personId=2971305&privcapId=6124664
Did I miss the bio/pharma/medical part?!
As of Fiscal Year 2017Background*
Mr. Zami Aberman has been Co-Chief Executive Officer of Pluristem Therapeutics Inc. since March 29, 2017. Mr. Aberman served as the Chief Executive Officer of Pluristem Therapeutics, Inc., (Alternate Name: Pluristem Life Systems Inc.) from September 26, 2005 to March 29, 2017. Mr. Aberman has been an Executive Chairman of Pluristem Therapeutics, Inc, since April 3. 2006 and has been its Executive Director since November 21, 2005. Mr. Aberman served as the President of Pluristem Therapeutics, Inc. from September 26, 2005 to February 5, 2014. He has over 20 years of experience in managing industrial companies, international marketing of breakthrough technological solutions to automotive, aerospace, metal industry and flat panel manufacturing, as well as experience in establishing and managing start-up companies active in the field of software development, chip development, advanced system development, flexible automation inspection and image processing. He served Chief Executive and Chairman positions in Israel, the USA, Europe, Japan and Korea. He operated within high-tech global companies in the fields of Automatic Optical Inspection, network security, Video over IP, software, chip design and robotic markets. Since 1996, Mr. Aberman founded and managed high-tech companies active in various fields. He served as the President of Elbit Vision Systems Ltd. and served as its Chief Executive Officer until December 26, 2004. Mr. Aberman served as President and Chief Executive Officer of Netect Ltd, specialized in the field of Internet security software. He was the Co-Founder, President and Chief Executive Officer of Associative Computing Ltd. He served as President and Chief Executive Officer of Robomatix Technologies Ltd., a public company (RBMXF.OB) from 1987 to 1996. He served as an Acting Chairman of Pluristem Therapeutics, Inc. since April 3, 2006. He served as Chairman of Display Inspection Systems Inc. specializing in laser based inspection machines. Mr. Aberman served as the Chairman of Rose Hi-tech Ltd. and VLScom Ltd. Mr. Aberman has been an Executive Director of Pluristem Therapeutics, Inc, He has been a Director of Alliance for Regenerative Medicine since October 2015. Mr. Aberman served as a Director of Ori Software Ltd. In 1992, Mr. Aberman was awarded the Rothschild Prize, for the development of a unique, laser based, flexible manufacturing system for the automotive industry, from the President of the State of Israel. Mr. Aberman holds a B.Sc. in Mechanical Engineering from Ben Gurion University in Israel
These are leaders... Look at the decades of applicable experience.
Then compare to these to our cast of characters.... Shouts volumes.
We simply do NOT have ANY depth of experience at this company, especially at the 'Co-CEO' level. SO Sad.
https://www.syntimmune.com/about-us/#leadership-team
Auto1
Wednesday, 09/26/18 11:52:33 AM
Re: None
0
Post # of 16081
Leadership Matters! Just wanted to share a REAL example of what a 'must have' clinical stage development company looks like when it is acquired for up to $1.2B. Study and compare... Notice, if Leadership has experience, you can get it done in pre, PI,PII's.
https://www.syntimmune.com/about-us/#leadership-team
VS.
http://www.pluristem.com/the-company/
"cash on-hand, by alxn"
fda, you stated that this was a 'prearranged deal'. This would mean you have insider information.
Please tell us more about such knowledge.
Auto1
Wednesday, 09/26/18 11:12:01 AM
Re: FDApproved post# 16057
0
Post # of 16080
No Doubt! Their history of deal-making and leveraging shareholder value gives such great confidence for our future!! Rumor has it they recently bought a couple of used copies of 'The Art of The Deal' at 30% on Amazon!
+++ They are now staying at Holiday Inns, exclusively.
Go Spartacus, Go!
FDApproved
Wednesday, 09/26/18 10:18:40 AM
Re: None
0
Post # of 16060
Only Pluristem, The Buyer And Pluristem's Broker Knows ! This Is Pure Speculation On My Part But The Tea Leaves Are Telling Me That There Is The Real Possibility/Potential For A Multi-Big Pharma Bidding War For The Rights To Pluristem's Platform Of Indications. I Just Came To That Conclusion This AM And It Appears Someone Else May Have Too ! Lets Hope That Happens !
We Are In Good Hands, As IMO Zami & Yaky Will Make Sure Any Future Deal(s) Are In The Best Interests Of Shareholders !!!
Nothing Trumps Leadership....
Everything rises and falls on Leadership. Sorry.
zzaatt
Wednesday, 09/26/18 12:59:13 PM
Re: Auto1 post# 16065
0
Post # of 16078
Quote:
Leadership Matters!
Not as much as science, clinical progress (P3), academic collaborators, medical research institutions eager to use Pluristem's products, massive patent position, products that target huge patient populations.... etc.
"Leadership Matters!" - yeah, and how would you know that Pluristem lacks leadership. Their accomplishment to date is pretty impressive.
Leadership Matters! Just wanted to share a REAL example of what a 'must have' clinical stage development company looks like when it is acquired for up to $1.2B. Study and compare... Notice, if Leadership has experience, you can get it done in pre, PI,PII's.
https://www.syntimmune.com/about-us/#leadership-team
VS.
http://www.pluristem.com/the-company/
"cash on-hand, by alxn"
Breaking for lunch?! Thanks for the cogent update! Looks like psti can use some help in the press-release investor relations department. you should apply.
FDApproved
Wednesday, 09/26/18 11:32:11 AM
Re: None
0
Post # of 16063
It Has Served All Of Well So Far ! 3 Phase Trials And We Do Not Have To Share Profits Yet ! GIDDY-UP ! They Know What They Are Doing !
zzaatt, waiting on your update on the progress of the Pre-Eclampsia indication that was given ODD back in 2014.
https://seekingalpha.com/article/3859416-pluristems-placental-cells-prove-superior-pre-eclampsia-leading-cause-maternal-fetal-death
"Pluristem has diligently studied PE ever since animal trials, done by leading PE researcher Brett Mitchell PhD., F.A.H.A. from renowned institute Texas A&M College of Medicine, found PLX-PAD cells injected into mice made hypertensive, recovered dramatically. Dr. Mitchell continued his groundbreaking work in this life threatening disease with new data published in peer-reviewed scientific journal Clinical Science last December. It showed Pluristem's exceptional cell therapy reduces placental injury via declines in blood pressure, the root cause of PE in pregnant women."
"An innate immune response, guarding against inflammation, is a welcome human by-product. PLX-PAD achieves this in comparison with stem cells from bone marrow and fat, showing superior results with better outcomes. With only one intramuscular (IM) injection, Pluristem's cells caused all symptoms of pre-eclampsia - elevated blood pressure, bad kidney function, blood vessel constriction, and inflammation to sink. Mother and baby remained healthy after treatment."
Auto1
Tuesday, 09/25/18 03:56:44 PM
Re: zzaatt post# 16034
0
Post # of 16061
zzaatt
Kindly report the latest update for the board, zzatt! It was not mentioned in the 10K. Thanks!
Tuesday, 09/25/18 03:07:44 PM
Re: Auto1 post# 16025
0
Post # of 16042
Quote:
Did it fail?
No it didn't! You miss all the important developments, too busy looking for what's NOT there!!
No Doubt! Their history of deal-making and leveraging shareholder value gives such great confidence for our future!! Rumor has it they recently bought a couple of used copies of 'The Art of The Deal' at 30% on Amazon!
+++ They are now staying at Holiday Inns, exclusively.
Go Spartacus, Go!
FDApproved
Wednesday, 09/26/18 10:18:40 AM
Re: None
0
Post # of 16060
Only Pluristem, The Buyer And Pluristem's Broker Knows ! This Is Pure Speculation On My Part But The Tea Leaves Are Telling Me That There Is The Real Possibility/Potential For A Multi-Big Pharma Bidding War For The Rights To Pluristem's Platform Of Indications. I Just Came To That Conclusion This AM And It Appears Someone Else May Have Too ! Lets Hope That Happens !
We Are In Good Hands, As IMO Zami & Yaky Will Make Sure Any Future Deal(s) Are In The Best Interests Of Shareholders !!!
Advertise Here
If it was a sale to a 'fund', expect that fund to get shored by the 'controller' or by PSTI in the next ATM offering. Just following history...
SrdghJack, would like to hear your thoughts on the Pre-eclampsia results. You might have the best perspective of all.
May have been force of habit for you to respond to 'FDApproved's message, Ehhem… mind your own business, you have plenty too.
Meeting must have broken at 3pm, !
Must have really offended you with this one. I'm so sorry... I didn't name any names though?!? How long have you been pattern challenged? just curious.
zzaatt
Tuesday, 09/25/18 03:25:23 PM
Re: Auto1 post# 16020
0
Post # of 16044
Quote:
Some folks here will never get the pattern Thunderforce1.
First you have to recognize the difference between a "pattern" and random events. Do work on that, then come back and we'll see if you've succeeded.
Quote:
You are getting it for sure - there are several other reasons for no 'contract' yet
"We will sell no wine before its time." Daily progress, we'll get there!
(BTW, what are the "several other reasons", it's quite intriguing, could we have just one, LOL)
zzaatt
Kindly report the latest update for the board, zzatt! It was not mentioned in the 10K. Thanks!
Tuesday, 09/25/18 03:07:44 PM
Re: Auto1 post# 16025
0
Post # of 16042
Quote:
Did it fail?
No it didn't! You miss all the important developments, too busy looking for what's NOT there!!
zzaatt
Tuesday, 09/25/18 03:03:27 PM
Re: Auto1 post# 16023
0
Post # of 16041
Quote:
Always a Orphan Designee, Never an Accelerated Approval Voucher Holder!
"Orphan status is an important designation with benefits for the company"
Clear Command Of the OBVIOUS! Thank you.
Quote:
Never an Accelerated Approval Voucher Holder!
Never say never (cause you'll be wrong).
This time it's an orphan designation, it's not an Acc.Appr., it's an orphan designation, it's also not a giraffe, it's NOT an infinite number things.
A Masters' in the OBVIOUS, I see. Well Done. Definitely, as you say, "boosts your credibility"
But IT IS an Orphan certification and that is good !!!!!!
Doesn't pay the bills, though.
CHEERS to that... So, what gives?
hopester
Tuesday, 09/25/18 02:06:39 PM
Re: Auto1 post# 16025
0
Post # of 16040
AN FDA APPROVAL MAY NOT IMMEDIATELY FORCE MFG; BUT IT SURE THE HELL WILL LAUNCH THIS STOCK INTO OUTER SPACE.
Giddy-Up Little gonads !
wow...new low. I'm going high!
FDApproved
Tuesday, 09/25/18 01:52:45 PM
Re: None
0
Post # of 16039
When The First Of Many FDA Approvals Arrives, Pluristem Will Be Lock & Loaded, With Millions Of Doses In Storage And Production At Maximum Fill & Finnish Capacity ! Our Meeting at The Ivy Is Roctober Royal ! Giddy-Up Little gonads !
Following your logic below... Should we then expect to wait for ANY FDA Approvals until the Thermo Fisher Partnership results in the ability to 'Make Millions of Doses, In Order to Meet Massive Global Demand." and receiving GMP certificatioin?
Wouldn't that take Thermo Fisher's product being fully GMP approved by the FDA on a time-line of +/- 2-4 years?
https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM407991.pdf
Seems all 'indications' would be serving 1M+ patient populations, and PSTI has already indicated their limited of 'off-the-shelf' internal manufacturing capabilities is 50K doses.
FDApproved
Tuesday, 09/25/18 01:02:19 PM
Re: None
0
Post # of 16027
An FDA Approval Will Never Solve Their Inability To Make Millions Of Doses, In Order To Meet Massive Global Demand. That Is What Is Important Right Now... Hence The Thermo Fisher Partnership ! Do Your Brain Some Good And Learn The Ways Of The Pluristem People.
Probably why there is no DOD contract, you think?
PS, thanks for stepping out of your meeting!!
Receiving an FDA approval does NOT force manufacturing...
Hard to believe a management team would have such POOR planning as to arrive at READY, FIRE, AIM.
PSTI applied for ODS in PE Feb 2014... "The tremendous unmet medical need makes this indication one of our top properties."
Did it fail?
Always a Orphan Designee, Never an Accelerated Approval Voucher Holder!
ARS
FAILURE TO ENGRAFT
AA
PRE-ECLAMPSIA
CLI
NO ACCELRATED REIVEW'S EVER GRANTED.... AGAIN, WHERE DID PRE-ECLAMPSIA GO? SHOULD HAVE BEEN ACCELERATED REVIEW, APPROVED AND BY NOW"
January 04, 2016, 09:30:00 AM EDT
- http://www.pluristem.com/wp-content/uploads/2017/10/Orphan_drug-ARS_final_isa.pdf
https://www.nasdaq.com/article/pluristems-plx-pad-cells-get-orphan-drug-status-in-the-us-cm560890
https://globenewswire.com/news-release/2013/02/21/525127/10022550/en/Pluristem-Receives-FDA-Orphan-Drug-Status-Designation-for-Treatment-of-Aplastic-Anemia.html
https://www.biospace.com/article/releases/fda-grants-fast-track-designation-to-pluristem-therapeutics-s-plx-pad-for-the-treatment-of-critical-limb-ischemia-cli-/
FDApproved
Monday, 09/24/18 09:08:48 AM
With Only 108 Pluristem Investors On The Planet And 113 Million Shares Outstanding, There Are Some Private Investors With Some Serious Amounts Of Shares ! GIDDY-UP...And Let's Hope We Rock In Roctober !
And yet, with "108 Pluristem Investors On The Planet", the Controller cannot be exposed. Makes sense.