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Article about N Korea nuke threat... PLX-R18 mentioned...alot
https://www.reuters.com/article/us-usa-radiation-treatments/north-korea-threats-spur-u-s-search-for-new-radiation-therapies-idUSKBN1FK2V4
FDA: Try to get a meet between The Twins and Philip Frost from OPK... the guy is always looking for the next big thing...
Thanks VOOV...eom
Voova: As you say, there are enough patients with the worst and best conditions in both groups so how is a decision made to approve the therapy or not... not arguing, just try to figure out a probable end point with an ambiguous target...
Bee: Thanks for your response... in following many clinical trials I have never seen a primary endpoint that isn't well defined... this endpoint, to me, looks like it may have some "decisions" involved rather that just pure statistics... let's hope the data is so compelling it will be easy for regulators to stamp it approved...
Spidey: Thanks for your response... I still get the feeling that not only is the endpoint ambiguous but the decision might have more than a "p" value involved... obviously, we need solid results to remove any decision making that may be involved in the review...
Input folks??... Couple days ago I posted my interpretation of the CLI primary end point... To me, it seemed quite arbitrary so I offered an opinion... Any other opinions or ideas??
Interpretation of the primary efficacy endpoint in the CLI trial... according to information on pg #17 of the 2018 Pluristem Company Presentation the end point reads: "Time to occurrence of major amputation of the index leg or death (AFS)"... this is a double blind placebo controlled trial... with, IMHO, an arbitrary end point not compared to any SOC will the results be based solely on the time difference between the PSTI cell therapy and the placebo when applied to amputation or death... in other words... someone gets the placebo and needs their leg amputated in 4 months and another patient gets the cell therapy and doesn't need a leg amputated... that's an easy one to see but what about a patient with a much more severe CLI and gets the cell therapy but requires a leg amputation while another patient receives a placebo and doesn't need an amputation... they project 246 in the trial... I wonder if it is strictly a numbers game... better results (greater than 50%) with the cell therapy and you get approval???... or less than 50% but lots of improvement shown in the secondary endpoint criteria... I hope the numbers will be skewed way higher on our end so it will be a no-brainer for the FDA and the EMA... now let's get to work and get this freakin' thing finished!!!
The FDA knows the work we do witnessed by the recent Expanded Use designation... IMHO, the next logical step would be to successfully complete the steps necessary to file for the all important RMAT designation... this designation, again IMHO, would be critical if not necessary to get early approval for the ARS product... secondly, any meetings with the FDA would be with senior staff and reviewers... the FDA would provide us with a detailed roadmap which would include the type of information and data that would be necessary in order to accept any filing for review... while involved in this rolling type accelerated process, I'm sure mgmt will be made aware of the importance of accurate and reasonable timelines and will be held accountable... the first cell based approval would not only be rewarding for PSTI, its shareholders and patients but also a serious ego booster for Scott Gottlieb and the FDA in approving the first Regenerative Medicine Therapy in the world...
Gary: I'm sorry to hear the ordeal you went through to reach this point in your life... your personal involvement certainly gives you a unique perspective and appreciation for how potent and important stem cells can/will be to treat a myriad of human calamities... I'm actually surprised a large pharma has not taken a run at PSTI either to embrace and develop this technology or to simply stop the technology altogether to protect its own assets... No matter the issue, industry or government entity, money, big money, runs the show... I'm glad you are doing well and I wish you all the best in the future...
FDA: Here we have an industry for decades brewing basically poison to be injected into humans for their systems to work out the differences between what we're made of and what is now added that was not part of the original recipe... drug companies spend millions on TV ads which outline the negative effects from this poison and, in some cases, admit they are not even sure how a particular compound actually works... Gene therapy and gene editing may be the closest thing we have to a "natural" therapy but recent papers have contemplated problems with the gene editing approach... So now we have, hopefully, come full circle and realize the best way to fix nature is use nature... I hope the folks at PSTI continue on its journey to bring the world closer to a safe, natural and effective therapy for all human beings...
How do you value a miracle??... today's press release featured one of the most aggressive breast cancers... surgery, radiation & chemo are the standard of care treatments... substitute that regime with weekly IM injections of PLX cells... there are no words to describe the difference in the patient's daily life or results of the treatment... nature fixing nature's mistakes... brilliant...
Boat: I sure do understand that... but... when dealing with biotechs it's all about buying the future... I guess we need a successful trial, a meaningful partnership or an outright buyout to realize the potential... news ain't worth much and certainly nothing that is sustainable pricewise... but... I'm not going anywhere because you just never know when it will happen...
Why is this, drug free, natural approach to treating cancer only worth a lousy 15 cents... why is this not trading at 6.00???
Bee: When Pluristem released the news on the CHA share sale they referred investors to the notes on the CHA agreement in the last 10q (ending 9/30/17)... there was no stipulation in the agreement that the collaboration would be automatically cancelled if all shares we liquidated... of course, that could change at any time... my thoughts remain that Pluristem did the sale to put the proceeds to work to advance the expanded CLI program... and... did so without doing another offering... As far as receiving compensation in the expanded program I have no idea how that would be setup... Usually, these types of programs are done without charge... I don't want to get too far ahead of what is going on... but... if we save just one leg??
Read the notes to the latest 10Q... the shares were always available for sale (some were sold in 2015) and the deal is still intact... there is nothing wrong with taking a profit on an investment and using the money where it is needed to advance the program... pharma does it all the time with their investments in smaller bio's... besides I thought you were gone so why should it matter to you...
The way I read on the 10Q the shares were always fair game for selling... IMHO, it appears the agreement is still intact despite the sale...
https://seekingalpha.com/filing/3755917?uprof=46
Gary: Welcome to the party... let me give you my thoughts on the potential of this therapy... AMZN sells a bunch of crap out of warehouses and has a stock price of over one thousand dollars... Now... we have a product that has the potential for saving your leg from amputation... what is that worth to you and the market...
https://finance.yahoo.com/quote/PSTI/community?p=PSTI
Maybe the reason for today's action...
Saud: With no other PSTI news, I believe your theory is correct... very important to get the RMAT designation to make possible the early approval of ARS...
Great discussion of MSC's... please read the "Results" & "Discussion" sectors at the beginning of the paper... it suggests that frozen cells delivered via IM right after thawing were cleared in 3 days... however, the same cells allowed to culture overnight prior to IM delivery lasted 3 months... I wonder what protocol PSTI currently utilizes for implantation... I wonder if we could have had a better result with United and the PAH trial if we had used a different protocol for implantation... truly exciting times but certainly not a walk in the park...
FDA: As it pertains to anything and everything in the market environment... I assume nothing
FDA: I believe PSTI must file for the designation before they can receive it... I believe the RMAT designation is practically a "must have" to insure the FDA looks at a DoD request for quick approval...
FDA: PSTI is not specifically mentioned as the provider of the stem cells... even if they are not involved in this activity the trial still adds to the credibility of stem cells as a therapeutic...
Interest is one thing... completed trials is quite another...
Boat: This is not a voucher...
Question: The "CHA" agreement had a Phase II trial approved in Nov of 2013... has that trial started?... does PSTI run any trials of their own?... it appears that all the collaboration agreements have the collaborator responsible for the trials and not PSTI... if this is the case, no wonder milestones mean nothing... I mean how can one provide accurate milestones based on another entity's schedule... I can understand the need for constant financing given the small size of PSTI on the other hand if they are basing their performance on someone's else's performance this could be a long journey...
Fairly new into PSTI... so what am I missing here... we have Biotechs with virtually no data in a small markets selling from $18.00 - 30.00... PSTI with strong, safe, early data in enormous markets selling for 1.65... it's like we're the Martin Shkreli of the market... for the life of me I can't see why this thing is not selling for at least 15.00... and with the first approval for saving lives and then saving legs why shouldn't we see this opening up at 50.00???... Amazon selling crap stuff out of warehouses for 1000.00/share and we're on the road to saving life & limb for 1.65/share... talk about bass-ackwards...
Scientific American... Oct 2017... great article on the placenta
Great accomplishment if PSTI's Fast Track Designation for CLI and/or the ARS product with Orphan designation could qualify for RMAT... I'm thinking RMAT would be as prestigious as a drug's Breakthrough Therapy Designation... talk about recognized credibility from the reviewing agency...
Stox: I agree... the biotech industry thrives/survives on data and trial results... the market won't take us seriously until we get something past the finish line... the new hot area of biotech is gene editing and gene therapy... regenerative medicine is hardly mentioned... we can change that...
Recent long position established (1.50)... the potential therapeutic benefit of our cells is dramatic... many "mini" trials have shown this to be the case in a myriad of indications... my question is why we haven't focused on one indication and dedicate resources to see that come to fruition... the CLI indication is what comes to mind... share price estimates of 5.00 or so seem so incredibly low given the fact that amputation could possibly be avoided with our treatment... I mean how much is a leg worth to the patient and to the market... AMZN is selling at 1000.00 for selling crap out of warehouses, PSTI is saving body parts!!... I'm here for the long term potential and look for this to be astronomically higher as we move forward... we do need to get down to the nitty gritty to make it happen...