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Love to hear any news on CBD Oil... We're more likely to get a boost from that before any PLX product... On-line suppliers of CBD Oil have been shown to have poor quality while some of the samples contained THC (not supposed to be there). Wonder if PSTI has generated any samples of the product...
Jaime: Read what you wrote... The DOD conducted the freakin' trials... Why would they have to confirm or comment on the PR unless you believe PSTI released results that were different from what was provided to them... PR perception is not the problem... Investors were looking for some inclination of an order somehow in the works... that's the issue...
So PSTI falsified the results and the DOD was complicit in the fraud???... Deep State mice lying???... C'mon folks...
The path forward is up to the DOD not PSTI... The company does acknowledge further testing which is obviously way better than the DOD curtailing development of this up and coming MCM agent...
It's part of the plan and a pivot point for PSTI.... An R/S just days before data release now clears previously restricted institutions to place their bets... A joint presentation and discussion of the data... Importantly... a confirmation that data is positive by the fact another trial for mustard gas was announced about a month ago... The signs are there for all to read... and I would say it is a very interesting and exciting story... Fight the urge to sell... it is just the start of the show... Good luck to all!
You save a leg and that's worth three freakin' cents... and you have AMZN delivering crap from warehouses and that's worth 1700.00???... This is certainly a WTF moment in the history of what's important and valuable... a leg versus a bag of diapers from a warehouse??? Geezus
Never thought I could get this happy about a six cent move in anything... Yeeeehawwww!!
All this selling in advance of the KOL meeting this Friday does not bode well for the agenda... If it's the SSDD we'll get hit with another down leg... only bigger...
I do not believe we'll have to show earth shattering efficacy in the CLI trial... There is nothing that will help these folks except, maybe, PSTI... The treatment has shown a good safety profile and with the absence of any treatment that shows any benefit the expanded trial was approved... If ten people are treated and we save even one leg or more importantly one life we'll have a rapid approval... The news today is more than significant... The FDA has shown confidence in the manufacturing procedure, the treatment, and the company and the willingness to give people a chance for life and limb...
connyank: Thanks for reiterating my point that a fraud is a fraud no matter the stripes...
So you walk into a bank and hold it up and get 86.00... Doesn't matter how much you got it's the fact you committed a crime... Frost knew what he was doing... he's just greedy... Remember Ivan Boesky??... that guy was worth 600 million plus but he had to have more and got nailed for insider trading... These AH's that lead others to slaughter need to have their cubes swatted in public in the middle of the exchange floor... Kinda' like Singapore... That crooked $h!t would end right now...
FDA: I'm not sure PSTI's serum cost will be lower since this is a high profit item for Thermos... more importantly, PSTI will have a guaranteed supply with batch to batch consistent quality...
zzaat: I hope you are correct on all you believe... my experience over the years with science stocks range from killer to killed so I take all of these developments with subdued enthusiasm and appropriate concern...
zzaat: The Fukie data was animal based... encouraging for sure... the IC data featured different results from different parts of the world... not sure how they sort that one out... so my overall assessment as a long is basically OK but nothing earth shattering... unfortunately, the market has pretty much agreed... I think the FDA may find themselves in a conundrum when the CLI data is finalized... the p value may not be there signifying statistical significance but if a few patients saved limbs and lives what do they do???... refuse to approve???... sort of reminds me of a high school short story: The Lady or the Tiger...
The one very important goal for PSTI's management, above all others, has been the desire to keep cell design and manufacturing wholly owned... Small science companies more times than not find difficulty being all things to all people... The Thermo collaboration leads me to believe PSTI will eventually look to ease out of their own trials, and thereby avoid the runaway costs and the inherent risks, to concentrate on developing a high tech cell design and manufacturing organization for the burgeoning regenerative medicine industry... The folks have shown outstanding success in manufacturing but only so-so results in trials... If you're a good pitcher you might as well concentrate on those skills rather than waste some of your time being a first baseman... All in my opinion folks...
Rob: I don't know if you are a golfer... but... you can hit a beautiful approach shot but you still have to make the putt... PSTI has hit the approach... we need the putt to make it count...
Rob: "Just one"... the elusive goal of every developmental science company...
I think if PSTI got a 10.00 buyout offer it would open at 4.00... good company with lots of potential that happens to have a really, really crappy stock... IC data good... down big... AR data good... up no louder than a mouse fart... and please... spare me the controller BS...
This stock reminds of a stock I used to own years ago (BCRX)… after watching the price action for awhile it was quite clear that every single bump in price was met selling and shorting... and I mean every single one... decided to sell out and do the same thing... worked for years... couple more days of this crappy action, especially after positive trial results, I may put the BCRX strategy in play once again... not the first time a promising company had a crappy stock...
Send:I agree the company was selling stock right from the opening... today's big 1st hour's volume and lower price is a mystery...
Good results with not much love from the market... yet... so patients need (2) 300 million injections for max benefit... MWD was virtually the same compared to baseline in like placentas and different placentas... an interesting result, as I garner from the PR, the fusion with different placentas demonstrated a "revasc-free" benefit that was not shown in the two like placenta treatment... if this assumption is true, the two different placenta option may provide more benefit and should be considered as the standard treatment...
Maybe pre-market or early in the trading session... IMHO, players have been shorting tomorrow's data for the last few hours...
How will the statistical difference in the distance walked between the placebo and our cells going to be determined... What is statistical difference in walking... 10 feet, 100 yards, 1/2 mile?... that seems, IMHO, to be an arbitrary primary efficacy point... plus... after one year and since most patients are 65+ years old, what if a certain number of patients develop other structural issues unrelated to IC such as hip or knee joint problems that affects the ability to walk... any consideration for these outliers that could change the result?... I believe we will demonstrate a benefit but will it be a statistical benefit by whatever criteria is utilized... good luck to investors and most of all to the human race...
It is encouraging that today's positive price & volume is up within the first half hour... good data, IMHO, on our very first official trial, would be presented by the co-CEO's... the PR would precede Karine's presentation and then she would have the good fortune and opportunity to go into more detail about the results...
Jack: I'd feel a whole lot better about this announcement if there was big volume in the July or Sept 3.00 calls...
Spidey: I agree a pre-announcement of trial data would lead one to believe results are positive... The "warning" description of announcement carries a negative connotation which I did not intend... it was, unfortunately, bad semantics on my part...
Wonder what the idea is of a "heads up" on releasing the data... In all my years of following biotech, I have never seen this type of data release "warning"... But... I'm happy they are giving the June option players a chance to make good... IMHO, I do not expect "home run" type data, you know, the curing of the disease in one or more patients, however, some evidential proof of meaningful activity would be more than a successful trial... Hopefully, media coverage would then change from the Russian meddling story to the PLX meddling story... The only problem I would have is at what point to sell because as new indications are tested and affirmed what price does one pay for, literally, saving life and limb... Good luck to the human race and nature's medicine...
I'm not sure about that one FDA... IMHO, the only way we get early approval is through positive data from the IU study with subsequent use by the DOD to solicit approval...
I believe that a product must have at least an RMAT designation or positive real world data for the DOD to request that product... so if the stars are lined correctly and we are a good ways into the first year research we may get lucky before 2021...
At least we finally have a definitive answer as to where we are headed with the product... and, thankfully, we do not have to pay for the research... the first year data will provide the protocol for the pivotal study as agreed to with the discussions with the FDA... it certainly is not the timeframe we all expected but, IMHO, the filing should be pretty close to early 2021... in the meantime, we have the IC data close to readout and lets hope we have reason to celebrate because positive results there will extrapolate to the ARS and other indications....
JP: Do you have a link to this message?... how did the guy know he was the first one in the trial... isn't this supposed to be a double blind trial... also, you never know if the guy has an agenda, is he real or he could be in the placebo arm... unfortunately, he could be an individual that doesn't benefit... not everyone will... don't get all panicky because of one dude... the IC trial due in June will, hopefully, give us a positive outlook on CLI...
Great News... less is better = margins are better... all we need is more people to understand what we have here...
Did we have the statement in past presentations that the Femoral Hip indication might be considered for the FDA's RMAT designation... That would be a nifty little addition to that program and should attract more attention to the pipeline...
Gary: You might have pharma come after PSTI for the exact opposite reason... and that is to dramatically slow down placental stem cell development to protect the billions of dollars invested in their own pharmaceuticals and systems and scientists and labs and sales force and so on and so forth... look at the car companies and their move, finally, into electric cars... do we really think this is a revelation for them... heck no... they wanted to protect their huge investment in the status quo for as long as possible before finally moving into the future... Elon Musk kicked the car companies butt into gear exactly like we're going to kick PFE's butt into gear...
Maybe 15.00 initially but when the media gets wind of the miracle and creates the "new paradigm" in treating diseases no telling where this could stop... remember this will only be the beginning so don't cut yourself off at the knees (no pun intended)... So good luck to all of us... well... most of us...
I guess they're starting in Japan without us...
https://www.biopharmadive.com/news/daiichi-taps-hitachi-for-regenerative-medicine-manufacturing/519783/
The radiation product takes on a new urgency given Putin's announcement of new nuclear capabilities... missiles that can avoid our defenses by going over, under and around "the umbrella"... scary time...
ZZaatt: I get all that... that's why I'm here... just pointing out the bio's of the world with basically no data released to support prices in the 30's vs PSTI with data supporting all kinds of indications selling for pennies... I'm no pie in the sky type of pumper but excuse me if I expect one day to see us open in the teens when a big trial reads out or someone wants a piece of the cake we're baking...
The puzzling thing about these positive readouts is they are only worth 3 or 4 cents... something akin to this in the "biotech" world is worth tons more..
Surprising the CELG spinoff did not create some excitement for us given the major backing for cell based therapy... sure it is competition but more importantly it is validity... dare I say we are several years ahead of this new entity but we do need to get a successful trial under our belt to solidify our leading position...