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Do you think the 'perfect' dose could be between 15M cells?
Do you know if there were any signals from the dosing trial to indicate if there was a any trend to dose/weight? - Thx
allo,
Do you think the 'perfect' dose could be between 15M cells?
Auto1
Approximately 250 People Have Been Injected With PLX-Cells With Almost Zero Side-Effects ! - allo/FDA
I think I'm falling for you.
How many Humans R18? What does this data show?
Your friend,
Auto1
“Our cells are smart cells, they know how to sense the situation in the body and will induce an increase in blood count only if it is needed,” Ofir said.
Unless you overdose it, then there is 'overload' - right allo? We've seen it now in both PASD and R18 - according to the data, AND your own posts.
allo, Acutually...
I know you are, but what am I. Until there is ANY HUMAN safety data for R18 in print, and reviewed, the claims you make in a comparitive nature to PAD are wholly false, allo. You have ZERRO balance you hen-pecked chicken-hawk. Get a clue, Jackie Sue.
Auto1
The Negegilble Difference Point Was In Reference To Their Safety Profile ! Man, You Are One Nasty Nattering Nabob Of Negativity !
Get Lost ! You Are Clueless About PLX-Cells !
"I hope to have meaningful discussions with Auto1 at some point in the future, but currently seemingly not worth engaging with given his/her current postings here"
Waiting on some meaningful discussion with you. Where'd you go? Tick-tock, Tick-tock
Seems like a waste of money to develop R18 if their difference is "Negligible".
The difference is significant. Look at the #'s of cells used/dose in the two different products.
Paracrine Vs. Endocrine - Big difference, look it up! Secretome, right Allo?
-Auto1
allo you stated that the controller likes it at $1.40. What is the significance/rational for keeping it at this price? Why wouldn't the controller want to keep the price at $1.25 instead and save him-herself $0.15 a share?
Spideyboy? Spideyboy?
Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review
Good post, Blu. Which of these designations do we expect R18 to receive based on the amazing ARS data?
How long does it take to hear from the FDA on these?
Remember when MAY 2017 was going to be the breakout?
Blue: Pluristem Received 7 Million From United. Why wouldn't you want to pay if this has 'billions' of potential? Maybe they got tired of dealing with ZamiYaky?
Look what United's stock has done over the same period since cutting ties.
Maybe United knows more than we give them credit for?
sorry, should have spell checked. Facts are correct though.
Spidey, sorry for slow response, been elsewhere making money... This is a long one, but important, educational & entertaining. Grab a cold one and some popcorn and follow along.
Spideyboy (Thomas),
I've just read your continuing posts over the last couple of days and I appreciate the humor. I'm not sure which you have the least of... scientific or business accumen, it's too close to call. You have clarified your lack of training, working knowlege of clinical trials, design, data, science, statistics & analysis of the like. I'll describe below, using your own post.
Btw, it only took me 3 clicks, to find Thomas. (I have really smart computers), not "going though my approx 50 previous posts" - don't flatter yourself - to learn a lot, including the fact you have 0 medical/science training or background.
Anywhoo. Here we go.
1) In your post below, "Another new bit of exciting data and in foloow-up analysis" - You stated "This is fantastic in comparison with Neupogen" - this is your 1st display of gross incompetence regarding clinical trials and scientific rigor. You cannot (scientifically) compare clinical trials, unless they are head-to-head. Next, you are going BACK to MICE data to claim 'superiority' of R18, and I quote in your 'science silver tongue' "very significantly better" "similiar or stronger support" (giggle) over a product that has been proven, approved & indicated for ARS, actually used in Humans. Your science-speak wouldn't pass on an exhibit at the science fair, much less among the educated. Put the shovel down wrt Neupogen. It's approved and indicated, and It Works.
2) You stated "particularly when it comes to the Japanese, things are almost invariably delayed. Japanese working culture is still quite traditional and requires unanimity of agreement on virtually everything and this can draw things out significantly." - oh my, did you really just say that? "unanimity" "everything" - what a stereotype, do you have something against the Japanese? DO TELL of your experiences in Japan, negotiating with pharma. You Sir, are insulting. You may have not heard of Toyota, Honda, Nissan, Takeda, etc. - they seemed to move at sufficient speed over the last 50 years, surgically dismantling the US automotive industry. Do some study on Edwards Deming. Remember him from your MBA classes - oh that's right, you don't have one of those either.
3) RE The Chinese, you state "it is very important to properly access the China market" now that the obvious has been covered, "China doesn't like companies coming by themselves and making significant steps there." Really? State your example(s)/source. Huh? After you tell us of your business dealings in Japan, please share yhour direct dealings in China too. I have that as well. "due to the China policy" - what 'policy' - name it!?! bs... "with many superior attributes to Neupogen" - there you go again. "and now looks to sign with the US government for a further cash injection." Thomas, your latest post #5176 outlining the Chinese drug reimburesement process, with such command of where PLX would find its place, was simply, in-a-word, Amazing. Has this been your personal experience at the table, in China? Yikes! http://www.fiercebiotech.com/special-report/top-10-big-pharma-investments-china - innovation drives demand and price - at least that has been my experience internationally including Asia & the Far East.
4) #2 example of clinical/scientific incompetence - "# of primates for pivitol study with R18." Really well thought out again, spidey - just look at the Neupogen Study designs and guess. Wow, good stuff. "I would suspect to the higher range" Pssst, its a little more complex than that, involves endpoints, probabilities, statistics and moa of the drug being evaluated, to name a few. (giggle again)
5) RE Timing of US 'stockpiling' "Well lets not get ahead of ourselves" as you say. Maybe we should get them to agree to pay for the pivitol study first, workout our pricing strategy (so we don't bastardize all of the other indications), and have some (any) HUMAN safety data signals from the interim analyis of the R18 Open Label, HCT Insufficient Responders trial, first, shall we?
6) You stated "I initially did the comparison due to Auto1's comments in his post #5073, where Auto1 stipulated 'Neupogen data was better than R18'. This had me concerned so did the DD and thought it would be good to share." spidey, this one is SO RICH, get ready. Here is my actual post, un-edited, Thomas. May I call you Thomas? If you are going to quote me and then 'pontificate', at least get the full quote correct, please. I stated, "Neupogen data (unscientifically) was BETTER than R18. Look for your self at the improvement vs. controls" - Now, you know why it is unscientific, I stated that above, even though your analysis is steeped in unscientific deductions and extrapolations. Now, since you went there, I'm going to show that your math skills are in question also. UNSCIENTIFICALLY, but following your analysis and logic: ARS Primate Survival - Neupogen 79%/41% control = 38% survival advantage.
PLX 85%/50% control = 35% survival advantage. 38% > 35% Neupogen wins. Unfortunately, in the real world, you cannot do this. Nevertheless, Ecellent DD on your part, Thomas. PS - #3 example of clinical/scientific incompetence
7) WRT #5113 and poor research, let me clarify, the trials you cite are not poor research. Your research is poor research, Spidey. You see you used 2 trials that were 'dose & duration' finding studies that were used to 'inform' the final primate pivitol trial for N - where you showed N had a 0% survival outcome. NO KIDDING - that is where it was determined the N dose should be delivered within 24 hours of exposure! - When this is done, as found in the Pivitol primate trial, the study actually gets stopped EARLY because of 'profound' efficacy and survival. This is #4 example of your clinical/scientific incompetence. For some reason, you like to look back at the wrong studies, that really don't matter anymore. Just like you did above with the mice. At least you are consistent however; consistently wrong.
8) "And thanks to Auto1's post today #5141 that I quote below:
"“We intend to develop this technology platform into a functional stem cell production system for the treatment of a variety of indications; the first being a safe, effective, and efficient ALTERNATIVE to bone marrow transplantation,” according to Pluristem chairman and CEO, Zami Aberman - May 22, 2007""
And probably your best example, spidey, of your clinical/scientific trial incompetence (#5), although the others were close, my "no idea" question - "When will this "first" trial commence?" you replied "This shows Auto1 has no idea what he/she's talking about or investing in" - REALLY? NO IDEA?, do you REALLY want to go with that? Ok, have it your way... Thomas, do you know the definition of the word "ALTERNATIVE" (available as another possibility, or in place of)- It would appear NOT.
You see, Thomas, here is the title of the trial you cite as the ANSWER to my "no idea" question. "Phase 1 Clinical Trial of R18 for the treatment of insufficient hematopoietic recovery FOLLOWING hematopoietic cell transplantation" - Thomas, this trial is called a "non-responder or inadequate or insufficient responder trial" - IF you look closely (or read, as you criticize me) it's in the title of the trial. You see, HCT (hematopoietic cell transplantation) is the first-line treatment in this study. Then, R18 is used, AFTER HCT, NOT AS AN "ALTERNATIVE". So my question above, is quite germain, and as of yet, UNANSWERED, even though this is what Zami promissed us back in 2007, to be "THE FIRST" trial. This trial has not even been proposed, much less conducted or even underway.
So, I don't think I am the one who has "no idea" what they are talking about, spideyboy...
In closing, in you words #5179, "I only write to clarify situations and provide any analysis, insight, based on sources and experience that I might know of that may impact product/company success."
spidey, thanks for the clarification, analysis & insight outlined above from your sources and experience!
- Best advice I can give... Don't lead with your chin.
- Auto1
allo- every public company is for sale and subject to buy-out every single day. Infact, you are buying pieces of it, right?
Tomorrow, PSTI will be for sale for $132.94M.
gunsnkars Monday, 05/22/17 09:55:45 AM
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Does anyone know typically how may NHP would they test for the pivotal study based on any previous studies??
Yes. You now have all of the resource at your disposal to join "Everyone has done their DD."
Dear gunsnkars,
Well, I went back and read the post#4999, but I'm not seeing your point(s).
Maybe I hurt your feelings by not recognizing that you already know Neupogen was approved for ARS? - BTW, you were replying to allo's post where she did not know there was an indication, not mine.
Or, were your upset because I criticized the fact that you started cheerleading for spidey's post #5064, which, in-fact, referenced the wrong studies, trying to claim there was NO survival benefit with N? Not good DD on your part, by the way.
And finally, your post below...I think you may be confused, as you mentioned in another post, you are not really an expert by anymeans on this.
Nevertheless, Please do share the name of the 'test' for radiation levels required to administer Neupogen in the event of ARS. I must have missed it in the actual pivitol trial and the approval documents. Here they are if you want to look them up and educate everyone.
When I do the math as you suggest, I come up with 1 million x dollars's. Is that what you came up with to? Certainly you did the DD on that before you posted, right? "Everyone has done their DD."
Definetlhy not smarter than everyone, just you.
Peace,
Auto1
gunsnkars Monday, 05/22/17 08:22:04 AM
Re: Auto1 post# 5113
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Hi Auto:
Go and read post #4999. The problem with you is you think you are the smartest one out here. Everyone has done their DD. No one blindly invests their hard earned money unless they believe in the company...I am long and don't expect quick bucks. I honestly believe PSTIs product is superior to Neupogen for ARS. The only advantage Neupogen has over PLX maybe the cost. However doesn't administering Neupogen require determining radiation levels through tests. Lets say the cost per test is X dollars . For 1 million people hope you can do the math.
Pluristem Provides Shareholder Update on Corporate and Clinical Developments
Good post, Allo. Would be great if there were an opportunity for Q&A with shareholders.
Words matter in these things:
A few thoughts...
- It appears there is more clarity as to the path forward for R18.
- Realistically, @ +/-24 months to indication, very exciting.
- The path appears to be a requirement for a pivitol study.
WHY? (the first ARS primate was 'dose finding only' - not statistically powered to measure survival, etc. Despite how this update is written, eluding to these results being 'statistically significant', ie. approvable with this data.
- Think about it, if the conclusions/claims that are made in this update by Zami, were indeed 'statitically significant' - this data be good enough to go, for FDA - (this isn't a slam, it is a fact)
- Make no mistake, other products have tested in pilot, have had compelling enough results, that the FDA grants fast-track approval process AND OD designation (based on the rarity of disease). - Even stopping trials early, because the efficacy is so compelling. (in ARS and other rare diseases)
- This update is a far more conservitive statement than those being made in the road shows (how many times in this release are the words potential, potentially and alternative vs. cure/solution) aka requires further study to confirm.
- ~ 9 Months of operating capital (IF trial expenses do not increase... This is a BIG problem. 5.5M/Q burn rate / ~ 49M cash with no organic revenue
- viturally certain will be NO 'initial stockpiling' without pivitol trial
- Japan deal? careful we do not become desparate and make a deal with the devil - ie. immunomed/seattle genetics
So it ALL comes back to leadership & negotiation.
Do we think the case has been made to shareholders WHY we PROMOTED Yaky (Pay raise, stock options & golden parachute) and now have 2 CEO's? IF you read the PR, its to "support the company’s growth and ensure continued success as it enters advanced stages of clinical development" - wasn't this his job before?
This is my concern, we have 2 CEOs now, NEITHER of which have ever put a deal together of this magnitude. NO increase in shareholder value. That's a problem for me - That is what WS analysts are looking at, that is why the share price is the way it is - NO controller needed.
Zami & Yaky have be our farm on 2Q17.
Winner, Winner, Chicken Dinner?
So what will happen in next 9 mos.
- Dillution or dillusion
- Deal with the Devil
- Buy-out for technology & patents
- BMT trial halted for 'breakthrough' results - advance to OD and fast-
track?
2 cents - Auto1
“We intend to develop this technology platform into a functional stem cell production system for the treatment of a variety of indications; the first being a safe, effective, and efficient alternative to bone marrow transplantation,” according to Pluristem chairman and CEO, Zami Aberman
- May 22, 2007
When will this "first" trial commence?
This is AWESOME!
Another ancient article (2007) for everyone's edification. How long to wait for a return on this investment?
Sunday, 05/21/17 03:00:59 PM
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UP
http://www.genengnews.com/gen-news-highlights/pluristem-buys-patents-covering-stem-cell-production-tool-for-2m/17851968
Thanks for the question
why buy? burn rate > capital + good science assets, buy-out target with new leadership commercialization expertise.
sekander -
Thanks for the question. - @ 2 years
I don't rag on the stock, I rag on the pumpers and Yaki & Zami who knowingly mislead the investors by overplaying 'results'and exaggerating 'claims' before it is proven or legal, then hide from Q&A from shareholders, no earnings calls, and then post on youtube!?
These are the wrong leaders, sorry. IF they cannot sell it to us, why should we be confident they can sell it to anyone. IMHO.
Here is a simple one, WHY do we need 2 CEO's? Does that create Shareholder value?
Auto1
Good morning - Just Saw A Commercial On TV For Neulasta !
Benefits outweigh the risks, indicated, approved. - FDA
2 years, we'll be there too.
Yawn.
FDApproved Member Level Sunday, 05/21/17 07:21:00 AM
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Just Saw A Commercial On TV For Neulasta !
90% Of The Commercial Was Talking About ALL OF THE POSSIBLE TERRIBLE SIDE EFFECTS ! UNBELIEVEABLE !
PLX-R18 IS A NO-SIDE-EFFECT BLOCKBUSTER ! WATCH & SEE !
Gret tip here, allo! Thanks for sharing.
NiCord® for blood cancers provides the first evidence that an ex vivo expanded graft can provide a robust and long lasting hematopoietic and immune recovery. It has an FDA BREAKTHROUGH THERAPY DESIGNATION and FDA and EMEA orphan drug designations. A phase 3 registration study is ongoing. Top line data will be available in 2019.
Gamida Cell is preparing for commercialization of NiCord, market launch NiCord is planned for 2020.
There can only be 1 explanation when a poster can only contribute 1-sided positions. Look back and see for yourself - as soon as they are called on their posts, they have to resort to name calling, no data.
As stated before, not paid here, and own a 'lot' of PSTI and buying more on the downs.
Would love to see in-writing, the other regulars admit or deny their conflicts of interest. Wouldn't you?
FYI.
http://www.payscale.com/research/US/Job=Pumper/Hourly_Rate
This is what 'data' looks like from a trial to investigate a potential ARS drug candidate: Not a 14 page Power Point presentation that is a cut-n-paste of your press release. Bottom line for R18 in ARS, an additional, actual pivitol study must be conducted before there are any remote possibilities of OD, Fast track, conditional approvals & stock piling!
Despite what the cheerleading squad tells you here. Just puruse back on all the posts proclaiming a buy-in is imminent and that we have seen the cure.
THAT is the truth.
This is real data: Why can't PSTI do this for us? Instead we get Youtube.
https://www.fda.gov/downloads/Advisorycommittees/CommitteesMeetingMaterials/Drugs/MedicalImagingDrugsAdvisoryCommittee/UCM350151.pdf
Blu- thought you were moving on, with prejudice. No? Nothing new here folks, move along. This isn't new data, it's history. 2015? Nevertheless, the information you post indicates Zami NEVER thought this first primate study would be 'promissing' enough to convince the FDA to grant Orphan Disease (OD) Designation or an Accelerated Approval process, much less, cause a "Buy-in" or "Stockpiling" of R18 by the US or ANY of the "Several Interested Countries".
Amgen as was granted ALL OF THE ABOVE with Neupogen's primate study.
Infact, "Reviewer’s summary observations: The sponsor supplied the results of a nonhuman primate (NHP) study that WAS TERMINATED EARLY DUE TO STATISTICAL SUCCESS upon a primary endpoint that showed filgrastim (g-CSF, 10/mcg/kg daily per leukocyte count results) therapy almost doubled the survival rate in comparison to placebo following
exposure of animals to approximately 7.5 Gy radiation."
"WOOOOOOOOOOW ....... This is Huge for them to have this research report and find us Top THREE in the World, That is Crazy Good !!!" -Bluehorsho
2 minutes of DD = Top Three Data
PSTI, a giant among midgets.
Folks, please do your own DD - don't rely on these pumpers and the mullet wrapper 'fake news' that they post. It's all out there for you to find yourself - you can do it!
What this DOES tell us PSTI investors is this: This is where analysts see PSTI in their development and market potential (among their peers) - At THIS moment in time - they are NOT ready to buy 'promising results'. Not YET anyway, hopefully in a few years. - Auto1
(RGBP)
Regen BioPharma, Inc.
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Hi Spideyboy, allo, thesaud, gunsnkars and the other lemmings not capable of using google on their own -
I have Prayed, twice, like you asked in your post. I've prayed for your ahgastness and hope it clears up soon.
Spidey says "So back at you, when you have clearly not bothered to even read the abstracts or introduction or even look at the dates of aticles used, then yes there is clearly no point having a debate as it would clearly seem you're not paying attention."
I do not pay attention to poor research. Sorry if I hurt your feelings. Thinking this kind of puts the debate to rest for a little while, right Tom?
Found this piece of data, dated March 30, 2015, that would be after your 2013 & 2014 articles, post your collection of 'studies', for everyone's review and education. After you read it, go back and re-read your post. Perhaps you have trouble with the Gregorian calendar?
You see, this is what an indication looks like. This happens after your drug meets endpoints and the potential rewards outweigh the potential risks for the patient. Also, please note the s/e information located in this indication.
https://www.fda.gov/emergencypreparedness/counterterrorism/medicalcountermeasures/aboutmcmi/ucm443245.htm
"Neupogen® is the first FDA-approved medical countermeasure to increase survival in patients exposed to myelosuppressive doses of radiation."
"In addition, orphan drug designation was granted for this indication, and this supplemental application received priority review."
For a company that uses YouTube to communicate with shareholders - the interest level below explains a lot! - "solution in my pocket" - Yaky
2 Days posted - 345 Total Views, Scary.
Zami Aberman - NHPs Study Results for ARS
Pluristem Therapeutics
Subscribed43
345 views
Flashback friday!
In her own words...that's 'crack' all right.
Giddy-up, get a clue bobby sue!
FDApproved Member Level Thursday, 05/18/17 11:58:50 AM
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Every Primate Injected With PLX-R18 Cells Survived ! That's Huge In The Eyes Of The Regulators ! Giddy-Up !
Funny allo. This from the crack pumper who so masterfully interpreted the R18 data as "no deaths in the R18 treated primates..."
Genious, oh my.
? Have a nice day!
FDApproved Member Level Friday, 05/19/17 03:58:42 PM
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Auto1 Has Many Issues !
Lack Of Common Sense Is A Big One ! He Has No Idea What He is Talking About ! Just Ignore The Shorts ! They Will Get Spanked Soon !
Indeed. Aquired a nice position today @1.25-1.26. Thanks PATI! Cheers.
Dear Spidey my webbed friend,
Thank you for your response, even if void of context and head to head comparisons (which cannot be made, scientifically.
RE Neupogen, the FDA gave conditional use exception to BARDA for stockpiling based on the ARS study data, immediately (within months) following N's primate study, was fast tracked by the FDA AND is Approved and Indicated as such.
Next, the N safety data you cite and compare is from the nearly 20 year, febrile neutropenia, oncology experience (CIN), not ARS, and even less scientific, you directly compared it to Primate Data, NOT Human, for R18 in ARS. - additionally, There is NO (0) data released, published, in HUMANS, period - much less 20 years. Yes, I know humans are being dosed currently for BMF/BMT, but there is (0) data, efficacy or safety in Humans, yet. So please don't make claims.
The context of "half-price" N you are in need of, was in response to allo's crack data expertise in posting a generic, bio-equivalent, challenge to N's patent. IE, a less costly alternative.
Further to, not trying to be condescending. However, when faced with some of the posts that are void of facts, and analysis and interpretation that is just plain wrong with incredulous defense defense of such, the 'facts' themselves, alone, will be condescending.
Finally, this really is not even worthy of debate. The fact is, PSTI has bet the farm on 2Q17; That I can tell you. IF, there is no BARDA contact in next 90days, no buy-in's from "many interested countries" no fast-track for R18, and we are "still discussing" a pivotal study design for R18 in ARS, we'll all know how 'superior' R18 is, Right?
Great discussion, I wish others would At least TRY to defend their positions.
Best regards
You have to understand
I'm LOOOOOOONG on PSTI, AND I'm buying again, now. BUT, the mis-management and lack of experience there is outrageous at this point. I think the good news is that if PSTI tanks, the someone will pick them up for a bargain - thats good for patients.
Someone has to ask the tough questions, that protects investors, and patients. Some posters here have NO balance, they just look silly.
giddy-up, get a clue bobby sue.
A double-lose for PSTI. IF they approve generic, gues what the Gov't will use? Hurts AMGN, but PSTI WAY more. Neupogen data (unscientifically) was BETTER than R18. Look for your self at the improvement vs. controls - and at half-price..
AMGN can handle the hit, PSTI cannot.
Let's put things in perspective here. It is great that R18 has no safety signals that are negative (although we do not know the COD's for the primates OR if there is a gender issue)
We are talking about a Nuclear Holocost here folks... Does anyone here believe with a rational mind that Neupogen would not be used in a Nuclear Holocost because of the (ANY) side effect listed? We are talking survival/life and death - Come on, that would be akin to not using chemotherapy for cancer patients.
Stop the insanity folks.
Well - maybe BARDA was just waiting for your scientific insight and data analysis. I'm sure they will jump based on your recommendation.
"no deaths...on R18" - allo
The 'wonder data' and "breaking news" you speak of is a simple powerpoint presentation on their own website (geesh) - there is nothing new there except the 20M data that they tried to avoid in THEIR press release - THAT is the reason there is NO additional coverage from ANY analysts or respected medical/academic journals. IF the data were as monumental as you say, it would be picked up everywhere. period.
The market is not stupid, management is less than average, data is confounding, not overwhelming and not statistically significant. THAT is why there was less than a mention when it was released and nothing from a reputable source since.
"no deaths...on R18" - alloidiot
FDApproved Member Level Thursday, 05/18/17 12:20:11 PM
Re: None
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I See No Reason Why BARDA Would Not Be Eager To Stock-Pile PLX-R18 Cells !
Big Contract Coming IMO !