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Good morning Allo,
Thank you for adding much needed balance and seriousness to the debate!
We could do with a few more investment geniuses here, I think.
Welcome to the board, Mr Dow.
HappyBee
PS Last time I looked (TASE) Pluristem were up 3.72% (Am I missing something?)
My view on the latest development of the Pluristem Investment Challenge:
How very droll!
HB
Hi PLX-11, Allo and Saud,
PLX-11, You say you have followed the company since 2012, closely, I presume. I am not sure whether it would be appropriate to comment any further on the content of the article other than that either it was written in a terrible rush and/or content was lost during the editing process as some really important "details" are missing (i.e. no specific mention of the EMA, adaptive pathway program, grant system, etc.).
There are so many other sources of more detailed and coherent information (financial and otherwise) about Pluristem in the public domain (including this board) that may be more helpful to the investor.
I endorse Saud's response to your question addressed to me. Further opportunities may also be coming from Europe? As Allo has said Tuesday will be very interesting.
HappyBee
Allo,
What do you think of this article? Are you familiar with the author? How familiar is he with Pluristem?
To me there seem to be some important details missing from the narrative.
https://seekingalpha.com/article/4179980-pluristem-regenbio-darling-founders-wind-take-another-look?page=8
HappyBee
PS Allo, thank you for the links and your inclusive and common sense approach. An example to us all.
PPS I see I am still "fair game", but I have news, "game over"! It takes two to play. HB
[]
Good morning Allo,
The early bird catches the worm.
"And That's The Way It Is"
I like it ( and counting the days).
As for your earlier post, all I have to say is if you laugh with someone you set them (and yourself) free (my viewpoint of the Pluristem Investment Challenge).
Cryptic perhaps, but at least I know what I'm talking about. :)
Best wishes,
HappyBee
Thank you for your excellent post, Gary.
I agree with your views. As Allo has said Pluristem have an experienced legal team that will guide them appropriately. I think there is nothing to worry about.
HappyBee
Welcome to the board, rocknroll350. The more the merrier. :)
PS Welcome to the board, PLX-11 and many thanks for your helpful contributions!
HappyBee
Deasktopna,
Please see link below that may or may not add further understanding (not just to you).
Please correct me, if I'm wrong but the PLX-PAD clinical trials are not carried out at the Pluristem headquarters in Haifa, but by hospitals, research centres, etc. around the world. We are expecting results of a Phase 2 trial and Spidey has given a very helpful analysis as to the trial protocol with reference to read-outs. Spidey is an expert in such matters as you may be aware of.
I recommend you read his post again. Apologies if my response seems a bit "waspish", it's not meant to be, but any contribution made in good faith on this board deserves some respect.
https://ttsec.org.tt/wp-content/uploads/Material-Change-Guidance1.pdf
PS I also suggest you read my post again when I posted the WHO link. I never claimed anything, it was purely meant for information. Have a further look at the WHO website which clearly sets out their remit.
HappyBee
Good morning Allo,
Spidey has already commented on your question and I defer to his expertise.
When I read the two versions side by side I noticed a few things. The use of language seems more descriptive with reference to some of the inclusion and exclusion criteria in the new version.
There have also been changes made to the exclusion criteria that may allow patients that may have previously been excluded to now be included? Please see below examples with my added comment.
"Exclusion Criteria
4. Subject having undergone surgical revascularization or major amputation less than 1 month prior to screening, or endovascular revascularization or minor amputation less than 2 weeks [Comment: changed from 1 months to 2 weeks] prior to screening.
6. Subject having undergone surgical revascularization or major amputation less than 1 month prior to screening, or endovascular revascularization or minor amputation less than 2 weeks [Comment: changed from 1 month to 2 weeks] prior to screening.
15. Subject on renal replacement therapy or with eGFR <15 mL/min/1.73m2 [Comment: figures have been added, but I do not know what they mean, could it make it less restrictive as a criteria?].
16. Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending another investigational device or drug trial(s), unless in long-term follow-up phase [Comment: it suggests that if anyone falls into the previous version's category they can now participate if in a long-term follow-up phase in relation to this specific point]."
Another observation is that a further exclusion criteria has been added. Previously there were 22 exclusion criteria and now there are 23.
This is the newly added exclusion criteria.
"17. Use of hyperbaric oxygen therapy, prostanoids, spinal cord stimulation, lumbar sympathectomy, wound dressing containing cells or growth factors, or topical platelet derived growth factor."
HappyBee
This is what the WHO has to say regarding the publication of clinical trial results.
http://www.who.int/ictrp/results/en/
http://www.who.int/ictrp/results/reporting/en/
Hi Spidey,
I did not see your post before I submitted my post. I agree with your views and it seems we are thinking along similar lines.
HappyBee
Good morning Allo,
I would have attended the event had I been anywhere near Berlin on that day. I am also very sorry to miss the "RegenerierBAR" (may help my cognitive function...). However I will watch out for any news coverage and report back.
Regarding the publication of the IC results next week another thought occurred to me. What would one do naturally having to announce bad news? I would be inclined to make the announcement as low key as possible and certainly not in tandem with an important conference (how embarrassing would that be?). Since the June publication date was recently confirmed there was no need really to pinpoint the exact date unless....
I expect the results to be positive and do hope that they may even be, to quote zzaatt, "MOLTO bellissimo".
HappyBee
Hi Saud,
Thank you for the interesting information. Do you recall the Edison report stating that a review of the Pluristem's value would take place once the IC results came in?
Best wishes,
HappyBee
For zzaatt (part two).
First I want to thank you, Allo, for the information posted yesterday and today (I will check out Dr Barzilai and his work later).
It would have been so interesting to hear zzaatt's much valued opinion on this topic and it is still my hope that we may experience a fully integrated environment here on the board very, very soon. I do like a pleasant surprise.
I thought the links below (part two, so to speak) may serve as a further source of information regarding regulatory matters in a fast changing medical environment from a national and international viewpoint that zzaatt (and others) may be interested in. The links contain a fair amount of information, but some of it is pertinent to the information from your previous post, Allo.
The links below are the EMA's annual reports for 2016 and 2017. Page 28 of the 2016 (Shaping the global regulatory environment) is very interesting.
http://www.ema.europa.eu/docs/en_GB/document_library/Annual_report/2017/05/WC500227334.pdf
http://www.ema.europa.eu/docs/en_GB/document_library/Annual_report/2018/04/WC500248201.pdf
HappyBee
PS Hi zzaatt, as you can see you are still very much part of our board ("in spirit") and I hope that we will be hearing from you again very soon.
PPS Apologies to the board for talking so much nonsense about the surprise guest yesterday. I looked at the link with the itinerary today and noticed the header (though I'm not sure what exactly is meant to be discussed). This vital bit of information did not reach my brain yesterday, it is becoming a "chronic condition", I fear...oh dear.
I think you may be spot on with your guesses, Allo. It does make sense, the eminent Mr Aberman or Mr Yanay. HB
Allo (FDA), I think we may be looking at what is described in German as a "Wink mit dem Zaunpfahl" (literally, a wink with the fence post), a broad hint of good things to come? It looks that way to me.
As for the surprise guest at the conference, I would imagine it to be someone quite impressive (for a split second I was thinking none other than Donald Trump :) ). My guess would be politician, eminent scientist (Nobel connection) or royalty, the Pope? I'll stop now. :)
HappyBee
Good morning Saud,
Many thanks for posting the article (and the message, received in full). This is great news, not much longer to wait. I will mark the 12th in my calendar.
You must be so pleased having received your recent excellent news and now seeing the date for the publication of the IC results confirmed. Fantastic (as zzaatt would say).
There will hopefully be lots to discuss this week and next.
Best wishes,
HappyBee
Good morning Allo,
Thank you very much for the link and the information. It is very much appreciated!
I am counting the days!
I hope the links below work because they seem so relevant to being an investor in this company.
https://jwi.charite.de/en/metas/person_detail/person/address_detail/winkler/
Hi Saud,
I am very pleased that Mr Aberman and Mr Yanay have been re-elected.
Best wishes,
HappyBee
PS Have a look at the link I posted earlier. You may find it interesting.
Thank you for the interesting links, FDA. The full paper (in German) is not on open access.
However, the link below provides open access to an article by Dr Holger Reinecke and others that was published in the European Heart Journal in 2015 titled "Peripheral arterial disease and critical limb ischaemia: still poor outcomes and lack of guideline adherence".
https://academic.oup.com/eurheartj/article/36/15/932/2293203
I also want to thank Spidey for the information posted today, now that was something worth reading.
HappyBee
PS Hi Melon and zzaatt, I hope you find the above link of interest.
PPS You are welcome, jfk. If phone and email fail a letter sent by recorded delivery (to CEO) may be an effective alternative.
Correction. The name of the author is Cade Hildreth. Apologies, not one of my brightest days. HB
Many thanks for this, Saud. It is quite a fascinating read. I remember a very good interview that Cade Hildebrand carried out with Mr Yanay (last year?). I think the link was posted fairly recently.
Best wishes,
HappyBee
PS I hope there will be good news soon about our friend "missing in action".
Hi jfk,
Please find below a link to a research paper tittled "Concepts and Definitions for “Actively Dying,” “End of Life,” “Terminally Ill,” “Terminal Care,” and “Transition of Care”: A Systematic Review".
I would encourage everyone here to read it. It does appear that the term "terminally ill" is not as clearly defined as I would have expected. Tables 1-4 are very interesting (open them in separate windows to see all the information). Given the ambiguity surrounding the interpretation of this term companies like Pluristem and BCLI may hopefully succeed in having their treatments administered to patients under the "Right to Try" bill.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3870193/
"The conceptual framework developed here may help to put the five terms in context with each other, with the aim of an increased understanding. Our findings highlight the urgent need to develop consensus definitions for these terms to facilitate daily communications related to clinical care, scientific research, education, and public policy. This may be achieved through Delphi processes or expert workgroups. Surveys of patients, clinicians, and researchers about their definitions for these terms also may provide additional insights. Until these terms are clearly defined and universally understood, it is important to provide a definition for these terms whenever they are used."
HappyBee
PS Thank you to everyone for links/information posted yesterday.
PPS Hi zzaatt, have a look at the link Melon posted. There is a reference to the number of injections administered in the CLI trial. We discussed this a little while ago and were not sure. It does appear, after all, that it involves 30 injections per leg (ouch!).
I completely agree, Saud, and while we are waiting for the trial results it is best to remain positive. Well done with your more recent investment!
Best wishes,
HappyBee
PS Hi zzaatt, stay positive! Consistency may be the solution.
Thank you, Allo, for the interesting link.
The quote below is very telling.
"After spending lots of time and efforts on clinical testing, these unique “living medicines” are finally poised to hop from the realm of clinical research to the world of mainstream medicine."
I does look that we will have many developments to discuss in the coming weeks and months and my hope is that all members of the board will be able to engage in the discussion. On this day, especially, I would like to express my solidarity with zzaatt who has contributed so much to the board. Regardless of differing views about the company nobody should be excluded from participating.
It saddens me that it appears that this has happened.
HappyBee
PS Hi zzaatt, I hope you are ok. Good luck.
I thought it may be a good time to remind the board of what was said in one of zzaatt's excellent past posts about his views on his Pluristem Investment strategy which I endorse.
"Actually, I must say, while I would welcome a big appreciation, I would
also welcome "a small appreciation", accompanied by good data,
since that would give me confidence
about a very positive outcome, and at the same time allow me to continue
to accumulate (haven't reached my target yet!)."
I regret that apparently we will not be able to hear such interesting views about future Pluristem developments.
HappyBee
Thank you for bringing this excellent article to our attention, Melon.
HappyBee
PS Hi zzaatt, I am very sorry about the latest and very unfair development in the Pluristem Investment Challenge. Best wishes, HB.
Well said, Thunderforce. I agree with FDA that something funny (and potentially highly immoral particularly given that Pluristem are striving to develop potentially life-saving medical technology) seems to be going on with the stock.
Very disturbing indeed......Not!
Hi Allo (FDA) and zzaatt,
Thank you, Allo, for the latest update on the institutional investor figures. This is very positive and perhaps a sign of things to come.
I liked this relevant quote from one of your recent replies (edited, but delivered in full to me by email yesterday!) to one of my posts, zzaatt, so I am re-posting it.
"We must never underestimate the inherent conservatism of
most investors, those of us who invested in PSTI are pioneers and
willing to take risks. Most people/institutions are waiting to jump in,
but they will as more data becomes available."
I think that you are making a very good point. This investment can easily be seen as very high risk, but as time has gone on I see it more and more as an investment with the greatest potential. I am increasingly convinced that the IC data will be positive. The recent article posted by Allo with Mr Yanay outlining Pluristem's plans for the future seems a further sign that good progress is being made behind the scenes.
I am also encouraged by Dr Gottlieb's approach (thank you again, Allo, for posting the link) and the fact that he recognises that cell therapies like Pluristem need to be assessed within a changing regulatory framework. The reference to real-world evidence (see quote below from remarks by Dr Gottlieb to the Alliance of Regenerative Medicine's Annual Board Meeting) seems to make a lot of sense.
"Moreover, we need to apply all the tools available as part of the Agency’s expedited development programs to facilitate timely development of safe and effective products, including using the expanded provisions for obtaining confirmatory evidence for accelerated approval provided through the regenerative medicine provisions of the 21st Century Cures Act. The use of registries and real-world evidence are likely to play an increasingly important role in this respect [my emphasis]."
We know that Pluristem are already collecting real world data as part of their CLI trial, for example.
https://globenewswire.com/news-release/2018/01/09/1285870/0/en/FDA-Clears-Pluristem-s-Expanded-Access-Program-to-Initiate-Treatments-of-Critical-Limb-Ischemia-Outside-of-Ongoing-Phase-III-Study.html
Best wishes,
HappyBee
PS zzaatt, the last sentence of your "edit" had me in fits of laughter. Thank you!
I agree, Saud, things are looking good for Pluristem and their common sense shareholders.
Excellent find, Allo. Thank you!
HappyBee
I Know I Don't Like It.....!
You are right, Melon. We need more than GL with the latest episode of the Great Pluristem investment Challenge.....
HB
PS Hi zzaatt, I hope you are ok. I'm in full agreement with you except one or two minor details.
I'm About To Lose Control....![][][][][][][][][][]
"Pluristem’s hematological and oncology division, will develop its own premium products and marketing capability."
.....zzaatt, over to you......
Hi Saud and Melon,
Saud, the share price pattern seems exactly as you describe it and it is perplexing. The news has been really positive lately. I have purchased shares both at a much lower and higher level (some time ago thinking it was a fair price). I think the stock is undervalued.
Melon you say "it just does make sense where PSTI is right now in their relationship to approval, unless Mr. Market has more data than we do." Did you mean to say "does not" instead of "does"? I think the IC trial results will be positive and my concern is that the stock may be manipulated to give the opposite impression.
As a retail shareholder (with no meaningful influence over the share price as far as I can see) I want the company to do well and the share price to go up accordingly. At the other end of the spectrum you may have someone (entity/entities) with sufficient purchasing power who may even be privy to information that you and I would never have access to and use their unique "advantage" in accordance with their own "best interests" which may not be that of the retail shareholder. I hope this makes sense. I have recently done a fair amount of reading on "stock manipulation" and it was quite an eye opener (for me, at least).
Best wishes,
HappyBee
PS Saud, I have been keeping an eye on BCLI. I am very pleased for you.
Good morning desktopdna, Melon and Saud (in alphabetical order),
Literally: You need to look further (up).
May the Force be with us Pluristem investors (who post) with a more positive outlook.
Best wishes,
HappyBee
Regarding the latest Pluristem Investment Challenge (PIC) and given it is the start of the Chelsea Flower Show I shall express my (PIC) views botanically.
Roses are red
Violets are blue
Is this sweet
I am asking you
(as the crucial new number seems to be two)
HappyBee