And a "Partnership" to boot !! GIDDY UP !!

Because it's Roctober. Felicia 69!!!

Falling like a Roctober. Giddy Up !!! GET A CLUE !!!

YES FDA! Europe The Final Countdown! Great Find, I bet Rocket Boy is packing... His bags. 10,9,8,7,6...

Sham exposed...need smarter people to pull off the hoax... Entertainment anyway.

"The causes of Preeclampsia are NOT well understood, and Auto's assertion ("the core") is complete nonsense! The placenta is the source of the MSCs used by Pluristem. The target indications are in no way related to the placenta (CLI, ARS, etc.)" - zzatt (just moments ago!!)

BEWARE, PEER REVIEWED JOURNAL DATA BELOW!!


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3381433/
"The root cause of preeclampsia is the placenta."
James M. Roberts and C. Escudero

Psssst. You're embarrassing your self and all of the 'bench scientists you had the pleasure of working with' - just saying.

https://www.sciencedirect.com/science/article/pii/S2210778912000025?via%3Dihub

www.pluristem.com/wp-content/uploads/2016/05/MitchellArticlePreecl_Final.pdf

New Peer Reviewed Article Describes Mechanism of Action of PLX-PAD in Ameliorating Preeclampsia and Indicates their Superiority over other cells

2010....tick,tock

http://pluristem.netron-webs.com/index.php/press-room/press-releases/press-releases-2010/92-press-releases/press-room-2010/411-14-sept-2010n.html

Houston, how much profit will we return to Shareholders on this mission?


https://www.bing.com/videos/search?q=apolo+13+clip&view=detail&mid=54C1A2AA7CC7C71C80DB54C1A2AA7CC7C71C80DB&FORM=VIRE

Simple questions, need answers:

zzaatt, do you currently own shares of PSTI? (this is a yes or no)


FDApproved, do you currently own shares of PSTI? (this is a yes or no)

Thanks.

Rocket Boy

Monday, 10/01/18 01:04:58 PM
Re: Auto1 post# 16196
"DEAD WRONG, and I don't think you're really sorry! BTW, how's your research into "consulting fees"?
You need to tell us that you've corrected your risible lack of knowledge, just so you can be taken seriously, LOL!"
zzaatt

In response to:
Quote:

"NOTHING is moving forward with radiation yet. IMO. Otherwise, it would be in the report. Sorry. - Auto1"

Dr. Kleinhaus, in her own words, must be lying about this then, eh? Only problem is that it confirms the R18 update in the 10K...

PS - The Doctor did leave out the 'Mustard Gas' Trial with the DOD...

PLX-11
Wednesday, 10/03/18 09:31:11 AM
Re: None
0
Post # of 16338
Response from Karine Kleinhaus:

"Hello,

Thank you for reaching out.

We actually have...the orphan designations you listed, but are prioritizing critical limb ischemia (ongoing phase 3 trial), muscle regeneration (phase 3 trial), acute radiation syndrome (completed phase-2-equivalent trial), and the phase 1 noted above[color=red][/color]. The platform technology can make multiple PLX products each of which can work in several indications, but as a company we have to focus our resources on a specific strategy. Thank you.

Kind regards,
Karine"


zzaatt
Monday, 10/01/18 01:04:58 PM
Re: Auto1 post# 16196
0
Post # of 16351

Quote:

NOTHING is moving forward with radiation yet. IMO. Otherwise, it would be in the report. Sorry.

"DEAD WRONG, and I don't think you're really sorry! BTW, how's your research into "consulting fees"?
You need to tell us that you've corrected your risible lack of knowledge, just so you can be taken seriously, LOL!"

Preeclampsia would have been a 'lay-up' indication for PSTI. The Placenta is the core of Preeclampsia complications. Just the facts, Maam.

The Preeclampsia Steering Committee will guide Pluristem's preeclampsia program including advising on various stages of clinical trials, from the design of the study protocol through processing patient feedback up to the final study report.

Committee members have vast knowledge of preeclampsia and a commitment to finding a treatment. Pluristem's Preeclampsia Steering Committee: Prof. James M. Roberts, M.D. University of Pittsburgh Professor, Department of Obstetrics, Gynecology and Reproductive Sciences Professor of Epidemiology, Senior Scientist, Magee-Women's Research Institute Prof. George R. Saade, M.D. University of Texas Medical Branch Professor, Division Chief Obstetrics & Gynecology Prof. Baha M. Sibai, M.D. University of Texas Medical School Visiting Professor Dr. David Williams, PhD FRCP University College London Honorary Senior Lecturer, Maternal & Fetal Medicine, Institute for Women's Health, Faculty of Population Health Sciences Prof. Simcha Yagel, M.D. Hadassah Medical Center, Israel Head Division of Obstetrics and Gynecology at Hadassah Medical Center Head of the Israeli Association of Placental Study

"For almost a thousand years, physicians have had no therapy to offer women with preeclampsia. A safe and effective therapy is needed to treat these women and prolong gestation. Pluristem's PLX cells are a unique potential therapy because they originate from the placenta, which plays a key role in preeclampsia." - Baha M. Sibai, M.D. University of Texas Medical School Feb 11, 2014 3:00 a.m. ET

Dr. Sibai, who was a moderator on the preeclampsia scientific forum, "Debate and Consensus: Preeclampsia Biomarkers in Clinical Practice, Are we ready?" at the Society for Maternal Fetal Medicine in New Orleans.

https://www.marketwatch.com/press-release/medical-key-opinion-leaders-in-preeclampsia-join-pluristems-steering-committee-2014-02-11

Maybe INSIDER INFORMATION?!?!?!?!

If indeed this has NOT been published publicly as a corporate 'strategy' or change in focus of 'resources' "in active development" from a previous direction, this would be a 'material disclosure' and a breach of fiduciary responsibility to shareholders. IMO

This deserves a deep-dive to ensure it is NOT the case.[color=red][/color]

PLX-11
Wednesday, 10/03/18 09:31:11 AM
Re: None
0
Post # of 16338

Response from Karine Kleinhaus:

"Hello,

Thank you for reaching out.

We actually have an ongoing phase 1 trial in incomplete recovery following hematopoietic cell transplantation, so the orphan drug designation is for an indication in active development in this case.

We do have the orphan designations you listed, but are prioritizing critical limb ischemia (ongoing phase 3 trial), muscle regeneration (phase 3 trial), acute radiation syndrome (completed phase-2-equivalent trial), and the phase 1 noted above. The platform technology can make multiple PLX products each of which can work in several indications, but as a company we have to focus our resources on a specific strategy. Thank you.

Kind regards,
Karine"




EichKing
Wednesday, 10/03/18 10:19:31 AM
Re: zzaatt post# 16326
0
Post # of 16338

Funny.....We've never heard them state such a thing....or anything regarding those "black hole" projects....must be TOP SECRET.

LMAO

Common Sense is as rare as an approval at PSTI!

FDApproved, you're the queen of recognizing 'Boiler Plate Responses' - give us all a break if you expected any other answer from Dr. Kleinhaus.

PS, just because this was there "strategy", doesn't make it a good one. Clearly in retrospect, is WAS NOT.

Perhaps the ERROR in Strategy that PSTI continues to have is NOT DESIGNING the correct trials for the best indications in the first place?!!?!

That saves a lot of 'resources' too. Leadership also owns those mistakes.

It looks as now we are making DOUBLE the mistakes with Co-Non EXPERIENCED CEO's. IMO.

Edwards Demming could use this case report for 'rework'.

Good points, actually... there are 2 phase I's in Preeclampsia with PLX-PAD. Potentially more data (and trials) in that indication than ANY other.


EichKing
Wednesday, 10/03/18 10:01:47 AM
Re: None
0
Post # of 16330

The company response, which clearly ignored the status of preeclampsia is nothing short of very low expectations They don't even acknowledge what we all know. After the ODD, they were to submit a clinical phase I DESIGN, which they have not done....in TWO YEARS. Like I said don't look over there look over here.

Preeclampsia is in the PSTI abyss, never to be heard from again......well that is until failures are reported on the "current strategy"...What a complete joke. I'd like to know the SPECIFIC question sent to them. Why didn't she expound on preeclampsia? They never have, they never will. PATHETIC....

Closes today $1.26

"The platform technology can make multiple PLX products each of which can work in several indications" - Dr. Karine Kleinhaus

and this is exactly the point! PLX-PAD cells were the same in Brueger's and Preeclampsia.

If we were talking small molecules in unrelated diseases with 'me too's', then her statement makes perfect sense.

HOWEVER...That's NOT what we have here.

A "Strategy" would have been to drive even 1 of these indications to approval to gather more safety & efficacy data to support 'Off-label' use until new trials could be done (funded) in new indications. The benefits in these others were already known back in 2003...

DO THE MATH over Time, $3-5Billion (at a minimum) left on the table by shelving these early ODD's. IT MAKES NO SENSE! - This is NOT brining shareholder value.

https://www.fiercebiotech.com/biotech/pluristem-s-plx-cells-receive-orphan-drug-status-for-treatment-of-buerger-s-disease

From 2011...

"Data from two phase I studies indicate that Pluristem's first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease. Pluristem's pre-clinical animal models have demonstrated PLX cells are also potentially effective in nerve pain and muscle damage, when administered locally, and in inflammatory bowel disease, MS and stroke, when administered systemically".

http://www.pluristem.com/wp-content/uploads/2016/05/Orphan_Drug_-_Preeclampsia_isa.pdf

Geesh Mikems, great idea... let's just start with 'generics' then, no more need for new products then, no original products allowed!!

Ugh... Without innovation, there are NO generics.


Just let the generics companies come up with the @$800M to possibly bring 1 product to market.

Out of the woodwork they come.

Pluristem Therapeutics Inc. (PSTI)
NasdaqCM - NasdaqCM Real Time Price. Currency in USD

1.26-0.04 (-3.08%)
As of 10:58AM EDT. Market open.

Why is June 2019 now the goalpost? Do you have inside information on their financial strength and burn rate?

Limited Resources = Limited Clinical Trials

PLX-11, I get that, however, these other indications are also HUGE $B markets and the results seen with PLX were Remarkable. Aplastic Anemia for one...

Wouldn't an alternative reason be that Leadership is/was incapable of getting the data in front of the most influential thought leaders, published in the journals with the highest 'impact factors', getting the results on CNBC etal., where the investor community can be educated, can buy the stock and fund the research? Seemingly, with success, the ability to fund ANY future research and development.

It makes sense for seasoned companies to 'pass' on some indications Vs. others, but with NOTHING, one would think at least 1 ODD would be likely approved through an accelerated review and cooperation with the FDA.

That's how others have become successful, getting the data in front of the investment banks & analysts that talk to investors. Selling the Story... This, IMO, is where CEO's with decades of biopharma experience have driven their companies.

We are talking Billion dollar indications here. Besides, if the 'market' is not large, all the more reason to have the ODD and be able to charge a massive premium for every dose, thus justifying the cost of development and a return for shareholders. Aplastic Anemia & Bruegers Disease for two...


Alexion in PNH is an example. A 12 patient study went into the NEJM and the rest is history. Just an alternative perspective.

HAVE A NICE DAY !

PSTI

Pluristem has a long history of ethically questionable reporting to investors


Stock price jumps ostensibly on analysis published by a discredited bucket shop


Heavy dilution is imminent and could have a significant negative effect on the share price


Top executives have zero educational and professional experience in the biotech field


LOOK AROUND FOLKS...DOES IT LOOK ANY DIFFERENT 3.5 YRS LATER?!?!?!

Feb. 2, 2015 4:37 PM ET| About: Pluristem Therapeutics, Inc. (PSTI), Includes: CVM, EVSNF, FLUX, ORMP

https://seekingalpha.com/article/2875876-pluristem-therapeutics-questionable-ethics-and-bucket-shop-coverage

Notice you never get a definitive logical reason for your valid questions.

Yes, I don't think they could produce a single scientific, fact & data based rebuttal for any of these serious questions.

The 'quote and criticize' to bury serious investor questions reeks of paid interest. Especially the ones who espouse to be highly educated and with a profound medical experience from the computer science arena to the bench scientist to the boardroom executive level.

They are good as the punctuation police, though.

SP on the way back to sub-$1.25 it looks like. Can you imagine waking up this morning at ARK Investments having bought in at $1.33?

Buerger's Disease... "The company says that various sources estimate the market for a cure at $2.5 billion."

https://en.globes.co.il/en/article-1000676759

Really not sure how you can screw up a company any more, actually, IMO.

I seem to recall that you can charge ALOT of money for 'orphan' drugs for 'orphan' diseases. Alexion did ok as I remember....

"The company says that various sources estimate the market for a cure at $2.5 billion."

https://www.mayoclinic.org/diseases-conditions/buergers-disease/symptoms-causes/sy

GIDDY UP !!

"According to the World Health Organization, preeclampsia occurs in approximately 6%–8% of pregnancies worldwide. It is estimated that preeclampsia costs the global health care system $3 billion annually."

“The tremendous unmet medical need makes this indication one of our top priorities. We look forward to advancing into human trials and we are hopeful that the very strong preclinical data for PLX cells will translate into similar results at the clinical level.”


"Having just recently established our Preeclampsia Steering Committee comprised of key medical opinion leaders, this Orphan Drug application submission is an important step in advancing our preeclampsia development program,” stated Pluristem Chairman and CEO Zami Aberman.

http://www.pluristem.com/wp-content/uploads/2016/05/Orphan_Drug_-_Preeclampsia_isa.pdf

Here are the facts, GET A CLUE BETTY SUE ! GIDDY UP !!

SrdghJack, interested in your thoughts on the Preeclampsia Data and safety in pregnant & lactating women.

You have been following psti for likely the longest, outside of Jackie and the other employees. (according to some here, that makes US "Stupid")

Another factoid for the fun factory. This is CLEARLY a key indication to pursue given the Market potential and Risk of Death. - NOT -

https://emergency.cdc.gov/agent/sulfurmustard/basics/facts.asp

So...the DOD thinks its safe for Mustard Gas patients, but not Radiated patients?? Doesn't the Fukishima data support safety? That's the only Human experience, Is there an undisclosed problem?

Aaaah yes, as FDApproved pointed out "Nothing can fix the inability to mass produce" - SO MAYBE, IMO, The first endpoint for psti is to actually demonstrate that they can scale production!!

Thermofisher? Is being able to scale production a NEW consideration for the Co-CEO's? probably.

Sham/Scam

PS, This is the ONLY "collaboration" with the DOD at this point. NOTHING (Just "Talking") is moving forward with radiation yet. IMO. Otherwise, it would be in the report. Sorry.

R18 is the "Cure" and is completely "Safe" - what's the hold up for a "Cure" in the face of Imminent Death? WEIRD...Something is not right.

Information on terrorism and public health. Provided by the Centers for Disease Control and Prevention (CDC).emergency.cdc.gov

I want them ALL, No reason we can't have ALL, Patients deserve ALL. It is IRONIC that some here tout 'cure' efficacy and 'safety' like 'tap-water' (outside of Detroit).

Yet, we cannot give it to pregnant women? Wouldn't PLX be pregnancy category A, placenta - placenta? Hmmmmm.

https://www.drugs.com/pregnancy-categories.html




zzaatt
Monday, 10/01/18 01:09:01 PM
Re: Auto1 post# 16198
0
Post # of 16260

Quote:

$5Billion in revenues 'shelved'.

And, an order of magnitude greater in revenues, for massive indications (CLI!!!!!!!) moving full speed ahead!

MAY is Preeclampsia Awareness Month!!

https://www.preeclampsia.org/PreAM

How's that Preeclampsia Steering Committee working out?!

“Having just recently established our Preeclampsia Steering Committee comprised of key medical opinion leaders, this Orphan Drug application submission is an important step in advancing our preeclampsia development program,” stated Pluristem Chairman and CEO Zami Aberman.

http://www.pluristem.com/wp-content/uploads/2016/05/Orphan_Drug_-_Preeclampsia_isa.pdf

PS - Whats the latest on the AA
(Aplastic Anemia) ODD?

2013... Another $1.3BILLION indication... On the shelf.
https://seekingalpha.com/article/1228371-new-orphan-drug-designation-for-pluristem-could-gain-access-to-fda-progressive-approval
More

Another clinical score for Pluristem Therapeutics (NASDAQ:PSTI) with the FDA's recent grant of Orphan Drug status for PLX cells in aplastic anemia (AA),
seekingalpha.com

So...then psti was pretty stupid to do a study in preeclampsia if they knew this ahead of time... But, they probably did not as they are a circus of amateurs in ALL that they do. IMO.

Good morning.

PS - Whats the latest on the AA
(Aplastic Anemia) ODD?

2013... Another $1.3BILLION indication... On the shelf.

Awaiting rebuttal.

https://seekingalpha.com/article/1228371-new-orphan-drug-designation-for-pluristem-could-gain-access-to-fda-progressive-approval

How's that Preeclampsia Steering Committee working out?!

“Having just recently established our Preeclampsia Steering Committee comprised of key medical opinion leaders, this Orphan Drug application submission is an important step in advancing our preeclampsia development program,” stated Pluristem Chairman and CEO Zami Aberman.

http://www.pluristem.com/wp-content/uploads/2016/05/Orphan_Drug_-_Preeclampsia_isa.pdf

No reason for your assumptions they will Ever be successful.

Damning and Crushing FACTS, EICH KING!

WELL PLAYED.

$5Billion in revenues 'shelved'. Serious cause for concern. Why?

Deader Than Dead

Another factoid for the fun factory. This is CLEARLY a key indication to pursue given the Market potential and Risk of Death. - NOT -

https://emergency.cdc.gov/agent/sulfurmustard/basics/facts.asp

Sham/Scam

PS, This is the ONLY "collaboration" with the DOD at this point. NOTHING is moving forward with radiation yet. IMO. Otherwise, it would be in the report. Sorry.

It's a hole.