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Did you really just say psti it's selling shares at $1.50?
Controller, right Allo.BEE
Hey allo. How does this happen if 'secret stockpiling' is already happening as you suggest? Top Secret?
2018 Milestone... "-Advance discussions with U.S. government regarding stockpiling of PLX-R18 for ARS •"
Doesn't 'advance' mean 'before'
And look at what is actually listed as"milestones" for this year... What happened to all of the"phase III readouts? Instead we get...
"Initiate Pivotal Studies ? Critical limb ischemia (CLI) -U.S., Europe (Japan yet to start) • Hip fracture -U.S., Europe • ARS ? Clinical Data Readouts • Phase II Intermittent Claudication (IC)-Q2/2018 • Phase I incomplete engraftment of hematopoietic cell transplantation-open label • Pivotal study in ARS ? Business Development • U.S. -Advance discussions with U.S. government regarding stockpiling of PLX-R18 for ARS • Japan -Finalize joint venture • Asia -licensing/ joint venture with partner for Asian market"
Ugh...what is wrong with you allo.? There will be NO stockpiling until the trials are done, sugar. They need more data, did you read the letter? You were squawking back in July that stockpiling was imminent then... More trials needed "protocol hurdle passed and funded in 2H2018"
sheesh...
That is absurd allo. The problem is that psti can't even enroll 125 patients in what should be a BLOCKBUSTER indication! That is the result of POOR INEXPERIENCED LEADERSHIP! The trial is TOO RESTRICTIVE and was accepted by psti because they had NO experience negotiating with the FDA.
The 'expanded access program', also known as 'compassionate use' was based on a PLEA from psti, because they so many patients were excluded...
125 patients, dear. Give us a break! This should have been filled LONG ago. It is a failure, not a success.
"This year, most milestones were met, others unfortunately were not, but we were pleasantly surprised to achieve other, unexpected milestones throughout the year as well."
"We were very proud to publish the promising results in anti-cancer treatment from our new product, PLX-Immune, which may open new possibilities in the field of oncology to treat solid tumors and offer new paths to help millions of patients around the world."
Didn't see any other 'unexpected milestones' in the letter besides this one. Is ANYONE comfortable with 2 CEO's being "surprised" about ANYTHING that happens in their company? That is what we call 'self-diagnosed incompetence" - 1) Its true..It was a surprise, right? - they wouldn't lie to shareholders 2) They actually put their 'surprise' in writing
Analysts don't miss these things either.
Lets take a closer look at this 'Update Letter'...
"As part of this acceleration, we are well positioned towards marketing with regulatory assets including U.S. Food and Drug Administration (FDA) “Fast Track Designation”, European Medicines Agency (EMA) “Adaptive pathways program”, Japanese Pharmaceuticals and Medical Devices Agency (PMDA) “Accelerated regulatory pathway for regenerative therapies” and recently received clearance by the FDA for our Expanded Access Program to treat patients unsuitable for inclusion in our ongoing Critical Limb Ischemia (CLI) Phase III trial."
"...we are well positioned towards marketing with regulatory assets..."
Marketing? Really, Marketing? I'm sorry, must have missed who is leading the 'Marketing' programs. The last time I checked, 'Marketing' is a COMMERCIAL function and is ILLEGAL outside of a label. Do we have a Legal department and did they proof-read this at all?
Pluristem Therapeutics: Questionable Ethics And Bucket Shop Coverage
https://seekingalpha.com/article/2875876-pluristem-therapeutics-questionable-ethics-and-bucket-shop-coverage
Folks, do you think this stuff falls on deaf ears with analysts? So...how does Zami respond? He promotes the accountant to a co-CEO. That's like splitting 6's and doubling down. And PATIENTS and shareholders are paying the price.
Submitted as evidence for the case for NEW LEADERSHIP -
The 'Letter to Shareholders' was written by, not 1, but 2 CEO's. Think about it. Could ANYONE see that letter taking more than @ 5 minutes to write? IS this what 'the best' leadership looks like? Really?
#impeachzamiyaki2018
EVERYTHING Rises and Falls on Leadership... Look at History.
Unfortunately, you have Ego over 'doing the right thing' with current leadership. As a second issue, due your diligence and review the background of EACH and EVERY BOD member - it will scare you to death. You will quickly see how a lack of experience leads to little-to-no oversight and accountability at the top.
Analysts are not stupid... They are NOT going to support a company with 'cure' products run by, IMO, Incompetent leadership & Oversight.
Fact Is... IT IS THE FIRST PLACE THEY LOOK, ask Eric Schmidt etal.
Actually Scott999, it reads 'OR' so, dead on... with 13K shares...
"Form 144 is required if more than 5,000 shares OR shares valued at more than $50,000"
While I believe psti truly has breakthrough products and I commend them for wanting to 'go it alone' - The reality is that these two co-eds are NOT educated, talented or experienced enough to lead such an effort. Let's at least agree on this. No disrespect to Zami, as the manufacturing patent for 3D was brilliant.
However, the type of experience required to 'go it alone' with the FDA - to develop & NEGOTIATE 'commercially viable' trial design & execution, defense NEGOTIATION of the disease and NEGOTIATION of clinical data, NEGOTIATION of the label and indication - require previous medical & bio/pharma/FDA NEGOTIATION EXPERIENCE...
Time to suck it up, put your egos and titles aside, and make a BOLD move to hire 'The Best' Medical/Commercial Leadership the industry has... "Phase III data coming 2018" - Do you really want a bachelor's degreed Engineer and an Accountant leading this CRITICAL minefield waltz?
Zami, you got us here, you did a great job - now take the COB role, make yaki a co-CFO, and hire the Leader of the Future in place. To make the point, please go back and read your 'Shareholder Update Letter' - it is truly pathetic in proportion to what you have led us all to believe we are on the precipice of over the next 3 years.
Come on, folks, put your money where you mouth is and put experienced, qualified people in place already so REAL analysts will take us seriously. I'm sorry but the more Yaki talks, the more nervous I get. IMO - I couldn't see him negotiate a cancer cure in a hospice center, Its cringe worthy, Right?
Let's get into position NOW.
Great catch, Scott999, I think you are on to something significant here. Generally, Board Members are listed as 'Directors' and trading falls under 'programmed' or 'scheduled' trades to avoid even the appearance of impropriety... It is definitely worth some more digging on each and every 'director' to ensure stockholder & patient equity.
"Each officer and director is deemed to be an “affiliate” and thus each officer and director need to comply with Rule 144 when selling common shares held either directly or beneficially. Form 144 is required if more than 5,000 shares or shares valued at more than $50,000 are sold during any threemonth period. Further, Rule 144 places limitations on the number of common shares that may be sold under the safe harbor rule. Generally, the number of common shares that may be sold in any three-month period is 1% of the outstanding shares of the same class being sold."
The SEC’s rules under Section 16(a) of the Exchange Act as well as Rule 144 under the Securities Act of 1933 impose reporting requirements on executive officers, directors and 10% shareholders.
The CFO and other select members of the Accounting Department can assist all executive officers and directors in preparing, reviewing and filing all Forms 3, 4 and 5.
While the Company has decided to assist executive officers and directors with Section 16 compliance, you should recognize that it will remain your legal obligation to ensure that your filings are made timely and correctly, and that you do not engage in unlawful short-swing transactions.
Hi: HappyBee... Common Sense Is As Rare As Genius
IMO...The Edison Report Is A Very Conservative Report As (All Analyst Reports Are,) As They Have To "Assume" The Very Least And Cannot Comment On The Very Likely Possibilities That May Come In The Near Future. I Believe, They Know Very Well That Pluristem Has The Potential To Become A Juggernaut In The Cell Therapy Space, As Their Third PLX-Cell Platform Product That Was Just Recently Revealed...PLX-IMMUNE Has The Potential To Change The Way We Treat Many Different Forms Of Cancer Tumors.
In My Opinion, PLX-IMMUNE Will Quickly Obtain Breakthrough Designation From The FDA After A Small 15-25 Patient Phase 1 Open Label Clinical Trial. As The FDA Will Recognize That PLX-IMMUNE Has The Potentially To Reduce Solid Tumors In Multiple Types Of Cancers In Various Organ Systems. The Obvious Global Market Potential Would Be In The Tens Of Billions Of Dollars.
IMO..No Analyst In The World Would Comment-On Pluristem's Future Potential If They Wanted To Stay Employed... Without Solid Clinical Data To Back-Up Their Possible Future Predictions. Which As We All Know Are Still In The Speculative Stage. However, One Can Read Between The Lines And Ask The Question ? Has Pluristem's PLX-Cells Ever... In Many Small Clinical Trials Ever Had A Bad Outcome/Read-Out? The Answer is No! Not Even A Siginificant Side-Effect !
The Entire Global Medical World Has Yet To Fully Grasp/Understand That PLX-Cells Have No Side-Effects That Would Ever Come Even Close To Being Considered Life-Threating. Even Though Many Patients Have Recently Died As A Result Of Many Different Types Of CAR-T Cell-Therapy Trials, Yet
You funny, allo. Feels like we need to pass the plate and take up an offering after this passionate message of deliverance. Just curious, after PLX cells cure 'everything that ails us' - What would people eventually die from? Or can we all plan to live forever, since we are on a 6-month - 3 year timeframe.
PS, thanks for drawing a line-in-the-sand with your June 30, 2018 timetable. You are bold and inspiring... When's that Lonza deal getting posted again? Gonna need a lot more than the 150,000 doses per year that we can make ourselves...
The FDA Continues Many Of Those Clinical Trials After A Brief Pause.
IMO.. The PLX-Cell Platform Is Far And Away The Most Effective & Safest Approach To Defeating The Scourge Of CANCER/IC/CLI/Muscle Trauma/ARS And Approximately 80 Other Life-Threatening Indications. If Pluristem Has Not Completed A Big Pharma Licensing Deal By The End Of June 2018. IMO.. It Will Be Safe To Assume That Pluristem Has Made, In My Mind.. The Correct Decision To "Go It Alone On All Fronts." A Decision I Applaud, As All Of Us Dedicated Longs Will Celebrate, Knowing We Will Be The Beneficiary's Of Owning What Will Become A Global Biotech Behemoth !
Then, The World Will Soon Come To Fully Understand... What Many Of Us Suspected 10 Years Ago..."The Incredible Power Of The Placenta." Evolutions 200 Million Year Old Placental-Cells Are Answer To Repair Numerous Developmental Problems That May Afflict A Developing Fetus ?
IMO...It Was Zami Aberman Who Questioned The Dogma Of The Day 11 Years Ago, Who Is Solely Responsible For The Discovery Of The Power Of PLX-Cells, Both Now And Long Into The Future ! Allo~
Well stated, Scott999. The current share price reflects the future potential minus risk - and even the analysts don't see a way clear, independently without dilution... We already know they won't sacrifice there stock options/rsu grants to demonstrate confidence in the future - so why would we?
Or...the Sosei deal is dead because they have to restate earnings AND have executive turnover, and once again, imho, psti leadership has stepped on themselves with little or no experience in 'partnering'or 'JV'ing' due diligence.
UTX bailed because of these 2...
blue, short term manic investors get burned 90% of the time....
Really? - show the data.
Someone Bought 170,000 Shares At $ 1.40
Was That You Auto1 ?
Funny.
Post the link, or don't post. - This is ONLY news if they are non-recurring ESOP/Grants/Options.
Pluristem Posted Management & Board Increased Stock Holdings That Were Done On March 19,2017 On The PSTI TASE Website !
Stock Is Currently At $ 1.34 On The TASE With 700,000 Shares Traded ! We Going Higher Today... IMO !
Are deals being terminated by #yakydealkiller to prepare the co. for an unincumbered sale? Pretty tough to keep the lights on if you are shutting all the revenue off.
-Auto1
"This adjustment is largely due to including the sale of a priority review voucher for PLX-R18 at $75m in our valuation."
Good find, midastouch017.
Hmmmm. Interesting that the analyst increases PSTI valuation based on the 'sale' of a 'priority review voucher' for PLX-R18 VS. the actual execution of a priority review with the FDA by PSTI.
NOT much of a multiple, any way you slice it.
Auto1
"Innovative Medical’s proposed investment of $30,000,000..."
IM -$30M
UHT -$55M
Sosei -$$$$
#Yakydealkiller
Auto1
Didn't Zami just come out a few weeks ago, saying the China deal was still on....?
I hear the band warming up on the poop deck.
#Yakydealkiller
Auto1
wonder what the reason was to scrap the china deal
Easy one... #Yakydealkiller
That's Very Good News ! Thank-You ! A Much Better Deal Will Come IMO !
Only Allo. can deduce good news from a failure.
PSTI is truly becoming De Duce!
More can be foud on this at The News Leader, WGAS.
#Yakydealkiller
D theG -
Auto1, I think we get it,...
Great, somebody get the lights.
Auto1
Here is a Legit person to follow for stem cells...
Good one, Blu. Always like to see "LEADERSHIP" on the first line. It inspires confidence when you know they have Been There, Done That before.
Auto1
FDApproved, lets follow your changing logic for a moment - IF we hold out for that 'ultimate' deal - how do we fund our ongoing research & "marketing preparation" (Yaky) on those 3+ Phase III programs over the next 2-4 years at the current/increasing burn-rate?
Serious question, need a serious answer. Sincerely interested to hear your thoughts & arguments beyond "Giddy-up" please.
FDApproved - do you ever engage in a discussion of issues?
Auto1
their reputation is at stake as a company and in....
their professional careers...imhop
they put the guidance out for 2107
"That's all I have to say about that" -FG
That says it all, Blu. YOU are exactly right.
Tick, Tock...
How many companies in this space
Move their CFO to CEO and Commericalize? Hint: 0
#dealkillers
It is Crystal Clear - PSTI is trying to 'save' their way to prosperity under this 'Wonder Twin' regime.
I appologize to the 'Wonder Twins' in advance.
Shape of... A Biotech Commercial Leader
Form of... A Scientific Visionary
Good morning would be nice.
"Partnership(s) Get A Clue Auto 1 !" - allo
Ok, YOU started it... "Partnership(s) Get A Clue Auto1 !"
Fall to read and digest...
allo, you've got some splaining' to do.
PSTI's FIRST 'Partnership' United Therapeutics Corp. (NASDAQ:UTHR)
09-19-2014
"United Therapeutics points to...Most Transformative Product"
"Milestones due to Pluristem are substantial: $55 million upon achievement of clinical goals and commercialization."
https://seekingalpha.com/article/2507205-united-therapeutics-points-to-pluristems-plx-pad-as-its-most-transformative-product
09-12-2015
Israeli cell therapy specialist Pluristem Therapeutics Inc (Nasdaq: PSTI) said it has received a notice from United Therapeutics Corp (Nasdaq: UTHR) ending its licensing agreement to develop PLX-PAD to treat pulmonary arterial hypertension (PAH).
FACTS: UTHR enters into Partnership(s) w/ PSTI THROUGH COMMERCIALIAZATION, 9/14 UTHR publicly declares "PLX-PAD Most Transformative Product" 9/15 UTHR ENDS its 'partnership(s)' with PSTI.
Yaky Yanay was appointed as Pluristem’s President in February 2014
Auto1
disclaimer: This is PC - pre-coffee.
Some? Many.
Melon4head (I love your handle),
Here are a few serious questions:
1) How do you suggest we fund PSTI for the next 5 years?
2) Little to show in sales? Who have we sold product to?
3) Are you prepared for severe dillution of your current shares with new market offerings or 7:1 reverse splits?
4) You claim to be a 'long' but how 'long' are you in at PSTI?
5) Do you think '5' years is a 'long'?
Look forward to your answers. Seriously.
Melon4head Monday, 06/12/17 03:29:16 PM
Re: bluehorsesho post# 5396
Post #
5398
of 5418 Go
Someone on this board is very impatient. I would like PSTI to be in talks right now- but only for sales rights or marketing rights should a product be approved. But it is extremely premature to put the company up for sale at this early stage- with little to show in sales.
That is- Unless some of you are looking to make a fast buck by September...
Most of us on this board still have a long term horizon- (up to 5 years for me). I will start questioning this company if the price is at a $1.32 position then...
GLTA!!
Yup. Futhermore
allo, lets follow your changing logic for a moment - IF we hold out for that 'ultimate' deal - how do we fund our ongoing research & "marketing preparation" (Yaky) on those 3+ Phase III programs over the next 2-4 years at the current/increasing burn-rate?
Serious question, need a serious answer. Sincerely interested to hear your thoughts & arguments beyond "Giddy-up" please.
bluehorsesho Monday, 06/12/17 01:18:34 PM
Re: FDApproved post# 5394
Post #
5396
of 5417 Go
according to your previous post, they should never sell out....
so now you are saying they should sell out for a higher offer.....
I know one thing for sure, your not very good at being their PR person and have a hard time remembering what you said......
I am glad you now agree that they should sell, it's just a matter of how much, thank you.......we agree on 1 thing for sure, they need to sell !!!
News Flash For Mr. Blue
Are You Suggesting That Management Should Accept A Low Ball Offer For Their Technology ? Wow ! So Glad Your Not The CEO !
That was not my take-away, probably not others' either. But What Evidence, Experience or Example do you have from these guys that THEY EVEN KNOW what a 'great deal' looks like? A 4th grader can watch 'shark-tank' and figure out that nobody is going to pay the futures price for today's results. UHC knew this, got tired of dealing with Moe & Larry, and bailed.
You cannot have it both ways, allo. You either believe this is THE greatest technology ever, and I think it is, OR you don't. IF you do, you invest accordingly - Great leadership doesn't have to know/do everything.
They just have to know WHO DOES know more than them in this arena, and drop their egos, get some STONES, and double down with investing in someone that has been there, done that. You know, RESULTS.
Unfortunately, in the absence of a crystal ball (or a crazy, shaky 8-ball) one has to rely on past performance to predict future performance. THAT is the way this game works, like it or not.
We don't want to be the band playing on the deck of the Titanic.
Cheers.
"that's a huge undertaking for a small bio."
Especially when NOBODY at the joint has EVER even brought 1 single product from bench to broker.
"management is smart enough..." What single piece of evidence from their experience can you provide for this
'feeling' of 'confidence' you have? Just 1 example is fine.
Hmmm - I'm going to build you a car. Not just any car, I'm going to build you a Bugatti Chiron. Now, I've never built a car before, infact, I have never even ridden in a car before, or do I work with anyone that has built or ridden in a car before. But please trust me, send me your money, buy my stock, I'm going to build you 'the best' car in the world.
Now, I'm convinced this is the level of science we have here. Without question. But, I'm not ready to ride if these guys are driving the car, much less building the car.
https://www.forbes.com/sites/markewing/2017/06/12/bugatti-chiron-first-drive-piloting-the-1500hp-261mph-two-ton-hurtling-meteor-of-molsheim/#7b4746f34580
thesaud Monday, 06/12/17 01:00:10 PM
Re: zzaatt post# 5390
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5393
of 5415 Go
that's right zzatt they are concentrating on 3 phase 3 trials in 3 different indications, that's a huge undertaking for a small bio. If the data is good they will come. I think management is smart enough to know if they need a seasoned vet to negotiate deals. lets see what happens in the next 6 months
"All they can do is to move toward the clinic (and approval) in
the various indications they have targeted."
Respectfully, but seriously...
Who is THEY?
If Mgmnt doesn't know how to get 'THEY' there, how will 'THEY' know how to get 'THEY' there?
Do we really think those that know the street, will give a 'vote of confidence' aka a 'Buy' rating to their clients with the strategy you describe?
Yikes.
What He said.
auto, do you think management can get out of
their own way?
Thanks for asking, I forgive you for the 'ignore' . Check me on this... the only bashing has been about management from the beginning - and silly allo because I do think shareholders and now patients, suffer from her unethical & illegal behavior (being investigated currently by SEC by the way). I think this is consistent.
No new Wisdom here, just recycled old Wisdom.
IMHO: EVERYTHING rises and falls on Leadership. Families, Business, Nations, Governments, etc. Time has showed us that you can have the best products, best scientists, best sales people, etc. but without the best leadership, pride and ego will relegate them to the land of 'almost'.
The short answer to your question is... No.
From earlier -
Auto1 Wednesday, 05/10/17 02:06:57 PM
Re: FDApproved post# 4906
Post #
4908
of 5412 Go
Yaky Yanay !
Co-Founder and Director
EyeCue Vision Technologies Ltd.
As allo always advises, Due Dilligence. Giddy-Up!
http://www.eyecue-tech.com/index.php/about/about-eyecue
https://www.evs.co.il/
Facts:
- No MBA, MD, PhD., PharD., medical or advanced areas, Accounting?
- '0' deal-making experience, much less pharma/biotech/orphan
- No board member / Directorships other than his own co-founding
- A light-weight at best
- Holds our PSTI future in his "pocket"
Yaky Yanay
Co-Chief Executive Officer, President and Director,Pluristem Therapeutics Inc.
Age 45 Total Calculated Compensation $436,533*
*Before his promotion to Co-CEO. This person is connected to 24 board members in 3 different organizations across 3 different industries.
Any questions?