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"IMO..They (DoD) Cannot Buy One Without The Other, As Common Sense Dictates The Auto-Injector Will Be Filled With PLX-R18 In Pluristem's Aseptic Fill & Finish Line Right At The Factory Then Cryo-Frozen For Long-Term Storage Or Possibly Lyophilized And Filled In The Auto-Injector For Long-Term Storage. It Will Be One Or The Other Depending How far Along They Are With The Lyophilization Technology." -fdapproved
Ok, earth to fdapproved… so, just like that, eh? Take that over there, pour a little into this injector thingy, throw it in the freezer or dehydrate it into a power, whatever, and start injecting nuclearized soldiers... Botta boom, botta bing. Just like that. OMGOMGOMG...
Um, silly question, but do you think the FDA might want to do a study with this new happy meal combo you describe? Lyophilized? I'm almost positive, that will just slide on in and by any need for bioavailability testing, storage integrity, etc. etc. etc. etc.
Should have this buttoned up in a couple of weeks or so?! Sounds like it.
Geesh. As Common Sense Dictates
"It Means The FDA Is Going To Consider RMAT Designated PLX-R18..." Really FDApproved? Are you stating that PLX-R18 has already received the RMAT designation from the FDA?! Seems implied here. Please clarify what you are claiming here. I wouldn't want anyone to be misled, by accident...
Please post the link to the FDA's award of the RMAT for PLX-R18, many here would love to read it.
Thank you so much.
Oh no, Thunderforce1. zzaatt said that we do not need an auto injector. Just vials, thawing device & needles. fdapproved said that too. Also, the deal is probably already done. fdapproved said that. giddy up.
Why do we need an autoinjector? We have vials thawing devices and needles.
So... Why do you think Sagilon can make the case for the value and potential of their portfolio with pre-clinical data to Eli Lilly, arguably the most conservative, sedimentary of all the big pharmas and PSTI can't sell 'the cure' and 'anti-aging' formula to 'anyone' with all of the Phase II/III data we have?!?!?!?!
ONE WORD, Leadership.
Agree... The biggest difference is its the quality and experience of Leadership... Staggering. Their is no substitute, Everything rises and falls on it.
Poetry. The ARK to the rescue plan is dope. Very possible and at pace, very likely. A mass vote of no-confidence could Shake things up for the better.
Ok, I'll bite, allo.
So... Here are legitimate "controller". Questions for those of us that have 'no clue... '
You have been here the longest, please educate us and answer these questions. Who knows, maybe you'll convince me and others...
Does the controller just have an unlimited number of shares at their disposal?
When does the 'controller Buy the stock?
What is the 'controllers' perfect price?
Is the 'controller' shorting itself?
Is the 'controller' making money with this stock while it is 'controlling'?
How long has the 'controller' been controlling?
How much have they lost?
How much have they made?
Why will it be the 'controller' who ends up 'controlling' our future?
What makes the 'controller' so special WRT psti?
Is the 'controller' working off of insider information?
Is the 'controller' a 'single entity' or a vast conspiracy network of well oiled, perfectly timed communication?
Thanks allo.
Presently the stock is NOT oversold... - - -hopster, yesterday see thread
Controller strikes again...
Spidyboy, very naive about what insurance will pay for. Look at the age group, many are already disabled and on Medicare and Medicaid, so CMS will be the primary payer, NOT insurance.
For younger patients NOT disabled, insurance does Not pay for preventitive care, as you are suggesting... The typical 'insurance' patient changes health plans every 2-3 years and insurers have no incentive for benefits longer than that, unfortunately.
Nobody has brought up the fact that this proposed dosing regimen is way beyond practical for a patient with IC...
Think about it, these patients, of not in-patient, would be subjected to 'how many visits and trips' to their doctor or hospital?!?!?!
They can hardly walk or are in wheelchairs needing caregivers. Can you imagine the struggle to make these appointments?!?!
Another reason a self-injector is a must. The ONLY problem with that is CMS will not pay unless doused in MD office... Many. Many issues to solve, 36 months at best.
CMS WILL NOT cover this if the primary indication is MWD. PERIOD. PSTI IMHO made a COLOSSAL mistake when they did not design and power this study for amputation as the primary endpoint.
Had they done so, I believe this PII would have propelled a priority and expedited review and approval by eoy 2019.
Instead, as was stated earlier, we are looking at 36mos with follow up.
That is a HUGE miss. Sorry, but Leadership is where success and failure rests .
"I have the CURE in my pocket" - Yaki Dabba Doo.
We May Get Some Good News Next Week, Now That Their 10Q Is Behind Them ?
Of course it never happened...
FDApproved
Thursday, 11/08/18 11:47:58 AM
Re: None
0
Post # of 18449
We May Get Some Good News Next Week, Now That Their 10Q Is Behind Them ?
They Must Have Signed A Contract For The Final ARS Trial !
NOPE!
FDApproved
Monday, 11/12/18 09:32:38 AM
Re: None
0
Post # of 18448
They Must Have Signed A Contract For The Final ARS Trial !
Acute Radiation Syndrome
Phase III-equivalent pivotal trial is expected to begin during 2019, program funded by U.S. government.
Page 27 SAYS IT ALL...LOVE IT !
BREAKING NEWS ! ABSTRACT HAS JUST BEEN RELEASED !
DUD.
FDApproved
Saturday, 11/10/18 11:04:54 AM
Re: None
0
Post # of 18447
BREAKING NEWS ! ABSTRACT HAS JUST BEEN RELEASED !
http://www.abstractsonline.com/pp8/#!/4682/presentation/59958
Consultant/Advisory Board; Modest; AstraZeneca, Bayer, Janssen.AbstractBackground: Intermittent claudication (IC) due to peripheral arterial disease impairs function and quality of life. Limited non-invasive therapies exist. Previous angiogenesis trials to improve IC were negative. Intramuscular administration of placenta-derived adherent stromal (PLX-PAD) cells increased angiogenesis and blood flow in a murine hind-limb ischemia model, and was demonstrated to be safe in clinical phase I studies. The aim of this phase II study was to evaluate the optimal dosing regimen, efficacy and safety of intramuscular PLX-PAD cells in patients with IC, Rutherford categories 2-3, due to femoropopliteal disease (NCT01679990).
Study Design: This randomized, double-blind, placebo-controlled, multicenter study included 180 IC patients (65.6±8.6 years, 22.2% female), randomized into four arms, each treated twice, 3 months apart: 300×106 cells twice, 150×106 cells twice, 300×106 cells once followed by placebo once, and placebo twice. Each administration consisted of 30 injections into the thigh and calf musculature. Primary efficacy endpoint was Maximal Walking Distance (MWD) at week 52 compared to baseline, determined by a standardized treadmill test. Values were Log transformed to reduce deviation from the normal distribution. Key secondary endpoint was the ratio of week 52 MWD to baseline in patients treated with 2 doses of PLX-PAD cells originating from different placentae.
Results: Mean MWD at baseline was 293±138 sec. Patients treated per protocol with two administrations of 300×106 PLX-PAD cells showed a 44% improvement in MWD at 52 weeks compared to baseline (Table). Two administrations of 300×106 cells were significantly superior to a single administration. No arm showed a statistically significant difference from placebo. Patients treated with 2 doses of 300×106 cells originating from different placentae showed a statistically significant 42% difference in MWD at week 52 compared to patients receiving placebo, and also demonstrated a statistically significant 83% improvement in MWD at 52 weeks compared to baseline. Clinically driven revascularization hazard, in patients receiving 2 doses of 300×106 cells, was reduced by 49% at week 65, though not statistically significant compared to placebo. Intramuscular administration of PLX-PAD cells was concluded safe and well tolerated.
Conclusions: Following these results, a phase III clinical study will evaluate the effect on amputation free survival of two administrations of 300×106 PLX-PAD cells originating from different donors in patients with critical limb ischemia unsuitable for revascularization. $graphic_{51C1868E-E68A-4EDF-
Here's my Technical Analysis...
Falling share price at an ever accelerating pace! No support before $.85. Look out below.
Open1.13
Bid 1.00 x 3100
Ask 1.17 x 2900
Day's Range1.05 - 1.13
52 Week Range1.05 - 1.65
Volume 343,411
Avg. Volume 224,038
Such a leap, so little data. Managing blood sugar is Not "curing" diabetes.
Healing Pancreases is Curing Diabetes...
Geesh...
Yes allo... You think?! You are 0/15 in assertions, predictions, surprise announcements and buyouts and takeovers.
Is say the market is spanking psti and YOU for being so overbearing and pushy positive. You see how ineffective you've become don't you? You are mocked continuously on yahoo, so much so, your posts don't last a day there...
Time to hang out up.
Have your ever just stepped back and read your 'technical analysis'? It's the definition of the painfully obvious. There is NOTHING to it, hopey...
Falling price keeps buyers away? Really? Oh my. Prices heading lower, will go lower? I mean why do you think there is ANY value in what you post ?? It's stupid obvious and common sense.
Put a sock in it.
Yes indeed. I saw it listed on ebay earlier.
Right on track... New 52 week low I see.
$1.05 and falling...
FDApproved, Is it JNJ or Novo or both or Amgen or Jansen or Roche or Teva or Celgene or Lilly or TF or that manufacturing company building in Isreal right next to psti, started with an L... Oh yes, LONZA?
PLEASE S let out all your assertions for us here. Many Thanks.
Woo-hoo... They got smart and not in the open market @ $1.16 instead of getting shared by the ATM flimflamstocksham...
I asked you a question.
They all sell the shares too...
Terrible analogy. Didn't even make sense. Ding doing.
You know what they say... Hope in one hand and psti in the other. I know what you'll be feeling... Trust me.
Never, Ever in NO!vember, GITTY UP!
Case in point...
Please share what you found.... Educate us FDApproved.
On another note... I am curious to know how/ where FDApproved came up with her last Thursday/Friday 'discovery' that the 'European' buyer for PSTI was NovoNordisk.
Their PR came out Yesterday, it smells of insider knowledge. #insider trading
$57MILLION... You see THAT is what a commitment from BARDA looks like. Psti? Still playing with a broken fiddle.
I see it, I see it! Johnson and Johnson kicking the door down to buy psti. Just like you said!!! You're a Genius.
Watch and see
Got to $1.15 today... Getting closer, watch and see. A long way from ANY positive price movement from all the earth shifting news of recent days past. You must hate yourself having to do the job you do everyday. Your parents are so disappointed....
OMG... Check out the bids and book. Going sub $1 by EOW... LOOK out BELOW!!!!
$1.15 at close today. Whatch and see.
Thanks for posting this Voova99. It's very helpful to demonstrate how psti/allo/fdapproofed work in harmony to twist and shape shift to kick the can down the road when the primary study is unremarkable.
The primary and secondary endpoints here are meaningless. Sorry. But they know it's true. FDA and CMS are not going to approve and pay for MWD... That's why this program has been delayed. They missed the most important 'primary' endpoint, didn't study it, amputations.
So what do they do? Tout other 'observations' and data points. NONE of which were powered for safety or efficacy claims.!!!!!
How do e know this?!?! Look at what they are focused on... NOT MWD... That's for sure.... Don't be duped. We are YEARS away from ANY approvals/contracts, R18 INCLUDED.
And yet... Knowbody cares because use you've deceived investors for so long. Crying wolf no longer moves anyone here.