The other thing to remember is that the USPO made changes a couple years ago, in that if you file for a drug or indication, and you get stuck in some issues that have to be addressed in a "non final rejection".....that the USPO grants you PRIORITY in filing...even though perhaps rejectd at first, that no other company can step in and file a similar patent indication OVER RGRX's filing and take it away if they do a patent writeup/application better. RGRX is first in line, issued or not....you can't file over them.
RGRX is now docketed for review with an ORAL hearing with the USPO review board. RGRX was granted a very, very similarly worded patent for TB 4 in GLAUCOMA..and the USPO granted that patent fairly quickly. So my guess is that the review board will know that and wonder what the problem is that they approve the TB 4 glaucome patent but not dry eye. SEE? It is why I think RGRX will win eventually. I give it a 50-50 chance that the review board just grants the patent without having to go thru the oral argumants. They can do that. because i think they know that for TWENTY YEARS the USPO has screwed RGRX in almost EVERY SINGLE FILING...and on many RGRX eventually wins. This time, RGRX I bet is fully prepared to get OUT of USPO venue and go to the DC Court of Appeals. That risks a bad black eye to USPO.
NO 50 cent buys yet. 35,000 shares added in last 50 days or so....37, .38, .40 and .45.
SHOW ME the trial design, that the same two endpoints where we didn't meet statistical in first dry eye...are NO WHERE to be seen in the new trials design. Then I buy more. YES, I AM worried the FDA will want all four subsections of cornea included. You have NO IDEA of what the design will be. You of all shoudl know by now.......do not trust Finkelstein....but even more than him, do not trust the FDA. I think the eye NK trial will be FAR more straightforward as to design....but it will take a lot longer to do. It is the nuances of the dry eye and what the FDA "wants" that concern me. ALL FINKEL TINKEL has to do is allow SHAREHOLDERS to know what the design is! HOW HARD IS THAT! The FDA approved the trial design in July! if the design is ALL GOOD for RGRX, WHY DOES HE HIDE IT? Same with GTree. TRIAL DESIHGN IS NOT INSIDE INFORMATION....it is PUBLIC information shareholders have a RIGHT TO SEE!
Ouch. Hope it wasn't a big holding in Gasfrac. It sounded so great on paper, but no big firms were using it. Had to be a reason. But hey.....RGRX has been to the death throngs too.....I always said RGRX a total gamble and I am taking it to zero and Bankrupt.....or a winner..just don't know if a small winner or a big winner.
I am NOT happy. Next week is September. G Tree and RGRX stated they hope to start dry eye and NK trials in September. FDA approved the dry eye in late July. they approved the eye NK in early August. BUT SILENCE. We need to see the TRIAL DESIGNS..not as much so for eye NK....but dry eye is critical. I do NOt like that RGRX seems unwilling to let it out...or G Tree. It reeks of non transparency. I am concerned that the FDA may no allow just the TWO subsets of cornea where we won, as the primary endpoint of new trial. I do not know. I worry that the FDA may ask for ALL FOUR of the subset corneal areas to be included..either as primary or secondary outcomes. If That happens we already know we did not make "statistical" on the previous two chosen subsections, but we DID on other two (four total). if the FDA wants ALL four subsections to be group judgesd as endpoints,, , we will start off knowing that we will likely not do well on TWO..and that lessens chances on our "statistical % measures" of success.. Next week is September. RELEASE The TRIAL DESIGNS FINKEL TINKEL!!!! This is why I so dislike Finkelstein. He hides things. He is hiding RIGHT NOW a great heart abstract, by a dr. very tied to TB 4 and RGRX. But I posted it to all, before RGRX does.
At the doses tested in anomals & humans..no side effects have been noted. But i'm not sure TB 4 can be touted to boosting your immune system. Don't think RGRX has said that.
Avon is still chasing TB 4. A couple days ago they got another relatd patent. it is not OF TB 4, but only some way that they scammed intop the product by saying they have in their wrinkle creme a compouns that "stimulates" TB 4. not sure it works much. but it shows that Avon really wants TB 4. This is teh second on they got.
Chen , et al. August 25, 2015
Methods for preventing, ameliorating, or reducing dermatological signs of aging are provided which employ active agents, other than a retinoid, that stimulate thymosin beta-4 expression in the skin. Also provided are methods for screening for substances which stimulate thymosin beta-4 expression levels and the methods of using active agents identified by the screening protocol in the treatment of skin."
THSI IS WHY RGRX is fighting so hard for TB 4 fragments. The fragment TB 4 is.....TB 4 but one made for non prescription uses in skin. Avon can't touch it. RGRX is first. But first fragment filing finally rejected. So RGRX just filed a tweeked one.
RGRX filed new patent application last month. Well, not totally new. It is related to TB 4 peptide fragments, which previous one rejected. So it appears they re-jiggered it into a new filing. Search it by teh patent publication number:
BETA THYMOSIN FRAGMENTS
Peptide fragments having amino acid sequences corresponding to portions of a thymosin beta 4, a thymosin beta 10 and/or a thymosin beta 15 amino acid sequence are provided, as well as methods of treatment utilizing same.
they just popped up recently on pub med. Don't know why the delay. I wonder if RGRX filed any patents towrds TB 4 liver. they don't have much money to do. Might give look.
Good news, we can keep up with Lee's Pharma now onm a US YAhoo page. Just go to Yahoo Finance and in it's quote symbol search box type in "0950.HK". It will oen to Lee's quotes. but what I like is that yahoo puts all the news releases and headlines. lee's gave earnings yesterday. Read teh release. they spoke of their pipeline and what is going on. they mention other drugs and areas, but total silence on TB 4 or dry eye.
busy day for Liver & TB 4:
"Liver fibrosis, the main characteristic of chronic liver diseases, is strongly associated with the activation of hepatic stellate cells (HSCs), which are responsible for extracellular matrix production. As such, investigating the effective regulators controlling HSC activation provides important clues for developing therapeutics to inhibit liver fibrosis. Thymosin beta 4 (Tβ4), a major actin-sequestering protein, is known to be involved in various cellular responses. A growing body of evidence suggests that Tβ4 has a potential role in the pathogenesis of liver fibrosis and that it is especially associated with the activation of HSCs. However, it remains unclear whether Tβ4 promotes or suppresses the activation of HSCs. Herein, we review the potential role of Tβ4 in liver fibrosis by describing the effects of exogenous and endogenous Tβ4, and we discuss the possible signaling pathway regulated by Tβ4. Exogenous Tβ4 reduces liver fibrosis by inhibiting the proliferation and migration of HSCs. Tβ4 is expressed endogenously in the activated HSCs, but this endogenous Tβ4 displays opposite effects in HSC activation, either as an activator or an inhibitor. Although the role of Tβ4 has not been established, it is apparent that Tβ4 influences HSC activation, suggesting that Tβ4 is a potential therapeutic target for treating liver diseases."
"Alcoholic steatosis, instead of being innocuous, plays a critical role in liver inflammation and fibrogenesis. The severity of fatty liver is governed by the concerted balance between lipid transport, synthesis, and degradation. Whereas scavenger receptor class B, type I (SR-B1) is critical for reverse cholesterol uptake by the liver, peroxisome proliferator-activated receptor-gamma (PPARγ) coactivator-1α and -β (PGC1α and PGC1β) are critical for lipid degradation and synthesis, respectively. Because betaine is a lipotropic agent, we have evaluated its effects on alcoholic steatosis. Betaine effectively prevented chronic alcohol-mediated (i) impaired SR-B1 glycosylation, plasma membrane localization, and consequent impaired cholesterol transport; and (ii) up regulation of PGC-1β, sterol regulatory element-binding protein 1c and downstream lipogenic genes with concomitant increased liver cholesterol, triglycerides and hepatic lipid score. Similarly, because of its anti-inflammatory and anti-fibrotic effects in other organs, we evaluated the protective effects of thymosin β4 (Tβ4) against carbon tetrachloride (CCl4)-induced hepatotoxicity in rat. Tβ4 prevented CCl4-induced (i) necrosis, inflammatory infiltration and up-regulation of α1(2)collagen, alpha-smooth muscle actin (α-SMA), platelet derived growth factor beta (PDGF-β) receptor and fibronectin mRNA expression; (ii) down-regulation of adipogenic gene, PPARγ and the up-regulation of epigenetic repressor gene, methyl CpG binding protein 2 (MeCP2) mRNA levels, suggesting that the anti-fibrogenic actions of Tβ4 involve the prevention of trans-differentiation of quiescent hepatic stellate cells into myo-fibroblasts largely by up-regulating PPARγ and by down-regulating MeCP2 genes. We therefore conclude that betaine and Tβ4 can effectively protect against alcoholic hepatosteatosis and hepatic fibrogenesis, respectively."
The dry eye patent issue is a pain, but no deal killer. The USPO will cave, imo, eventually, as they have on many other RGRX filings. USPO had NO problem giving patent RGRX for glaucoma, so they will eventually give in for dry eye. RGRX will take it out of USPO and in to DC Court if need be. Regardless, ANY new approved drug get's automatic 5 years exclusive. HOW BAD is that? IMAGINE? What if a full patent is 15 years. And say RGRX was granted it 6 years ago, They's only have 9 years left. See? we get 5 years free (if approved)...so to make up short life, RGRX just charges more. Consumers screwed. ALSO??? USPO has NEW RULES in. NO ONE can step OVER RGRX and file ANY similar dry eye patent because RGRX 's application seems iffy..because USPO instated a NEW rule - FIRST TO FILE GET'S PRIORITY STATUS and no one can step OVER that and try to steal with a different filing. RGRX will ALWAYS be FIRST IN LINE for TB4 dry eye. Odds are? The appeals panel might cave and give it with no hearing. or? they don't and the oral hearing comes. they KNOW RGRX is fighting angry and will take it to a DC Court if need. USPO will not risk that, IMO. And if RGRX get';s it, the timing is FABULOUS. because the 15 year clock starts ticking when issued, and the phase 3 will END a few months after. RGRX may get a FULl 14 YEARS if issued, as opposed to so many that get patents PRE CLINICAL or phase 1 timelines and they LOSE another 6-7 years doing MORE trials. We will be in cat bird seat if we get it soon, with potential full 14 years exclusive. if not? We get 5 years and charge $$ more to make up it's shortened life span.
The thing is the dry eye patent is all about being "lyphosized"...the USPO had NO ISSUES whatsoever isuing RGRX the eact same language FULL PATENT for this in EYE GLAUCOMA....but the d**k examiner is playing games not in dry eye. I have followed carefully most of RGRX patents. It is rare that RGRX did NOT go thru hell and multiple rejections before getting it. It is all a game of F, F...and the harder RGRX lawyer fights back...then all the USPO guy looks for is a way to save some face....then they back off and give it. The dry eye guy is a little more stubborn. But tehe fact that RGRX is taking dry eye to a FULL oral hearing, shows they ain't playing around. And if that oral hearing is no good, RGRX will REMOVE the whole next proceeding OUT OF THE USPO purview and takk it to the DC Court of Appeals. IMO? the "d**ks at USPO will never let it go that far.....because the USPO CANNOT risk getting overturnd at DC Court.....because then what it PROVES is that they don't know what they are doing and they put the applying company thru unmitigated, unreasonable hell and expense. And teh USPO shoudl be allowed to be sued, if a DC Court awards patent..for the years and years of stupidness and hell. It cost RGRX a TON of $$$ to fight these idiots.
Bonkers donkers again. ignore him. B7 mentions patents/ Dry eye? . Issues yes, bit no disaster. We are now at the USPO appeals board after latest examiner rejection. This panel is now reviewing RGRX lawyers argument against. RGRX has been given a docket no#. This USPO panel has teh right top agree ith RGRX, and thus immmediately grant the patent, or they can agree with examiner and go to a full orla hearing. but teh panel CAN overrule and grant teh patent before that. If RGRX goes to oral and loses.....RGRTX next stepo is to go to DC Court. Which I am sure they will. The USPO better DAMN WELL BE SURE of their case before it goes to DC Court. It is a HUGE black eye if hey end up in DC Court OUTSIDE OF USPO, and they lose. It is a game of who blinks first. RGRX is not. I think USPO will.
SECOND! EVEN if RGRX loses patent stuff, NO MATTER WHAT HAPPENS, if RGRX get's approved FDA grants FIVE YEARS automatic exclsive. No full term. Which means all RGRX does is RAISE THE PRICE of teh drug if approved to make up.
THIRD. Tming is fabulous in ONE sense. A patent runs 15-16 years. Had RGRX gotten the patent for dry eye during pre clinical or phs 1, there will be at LEAST 5-6 years wasted while trials and funding progress slowly, whittling DOWN patent. But it is rare I think that a drug is going INTO a Phase 3 and no patent. which means if drug works and approved. the PATENT CLOCK will start ticking FAR LATER...and we get almost a FULL 15 years! Which makes TB 4 MORE valuable. Most firms get patent FIRST before phase 1 or 2.and you can LOSE 5-8 YEARS of your 15 year patent in trials time. Dry eye is coming at same time. If you waste 8 years that leaves 7 years. SEE? Only 8 left. BUT NO MATTER WHAT, patent or not, RGRX will get 5 years anyways! They just charge more if need be during 5 years!
I'm temped to buy. Down 4 cents to .40.........maybe will....but far too long experiences with Finkel say hold until I see the trial designs. Until I see them, and they match what we all hope on sub set endpoints dry eye....I'm wary. And I don't trust the FDA either. Two subsets may or may not be enough for them....because the other two sections cornea we did not make statistical efficacy. I do not know enough about corneal subsections to guess what FDA will say. Other way I look at it? Say the 2 trials designs get out for us and they read GREAT........many of us woudl buy when we see if they are all well and good. But what are the chances of the MM's who are short quite a lot....that they will see read and understand how important teh trial design is......if it is exactly what we all hope, the MM won't care. They'll just see it as a short term pop to the POS they think RGRX is.....so they will short what they have to....be it .50, .55 or .60......the MM sill short me all I want. Which is good for us to make them even shorter!
It's no wonder no pro bio investors don't trust or believe in Finkel. He hides things. JUST LIKE HE HAS HIDDEN THAT NEW HEART ABSTRACT I FOUND. For what he has put investors thru, WHY are they not disclosing the critical trial designs? It;'s why we are down. No one trusts him.
Poor. poor bo. He is fixated that I did not buy RRX at 5 cents or 10 cents or 15 cents (I did at 19 cents though). He pats himself on his back he did. But that was "risk on. Then he harps that it all up to KOREANS? and they control all data and results and info? BUNK, JUNK. The FDA and NIH mandate transparaency on clinicl trials. SO WHERE IS IT? READ:
"ClinicalTrials.gov contains information about medical studies in human volunteers. Most of the records in ClinicalTrials.gov describe clinical trials (also called interventional studies). A clinical trial is a research study in which human volunteers are assigned to interventions (for example, a medical product, behavior, or procedure) based on a protocol (or plan) and are then evaluated for effects on biomedical or health outcomes. ClinicalTrials.gov was created as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA required the U.S. Department of Health and Human Services, through NIH, to establish a registry of clinical trials information for both federally and privately funded trials conducted under investigational new drug (IND) applications to test the effectiveness of experimental drugs for serious or life-threatening diseases or conditions. NIH and the Food and Drug Administration (FDA) worked together to develop the site, which was...."
it goes on and on.
BO! The ONLY way RGRX get's to $10 is a clear trial WIN. The only way we get a trial WIN, is if we have the perfctly designed trial. Until RGRX or clinical trials shows the trial design, I am siting with the recent 30,000 more I bought. On a trial win, TB 4 over a bunch of years could be a $1 billion drug. It may beat restasis. So quit being silly, bo.......5 cents, 15 cent, 40 cents, 50 cents..MATTERS NOT. Chicken feed. NONE of those prices purchase mean a HILL OF BEANS..if the trial does not work.the only way the trial will work for TB 4 is getting the right TRIAL DESIGN. History shows that RGRX, flops designs.
Now you're reaching for stupid, bo.........that NO ONE will see trial design until Koreans allow it/ BUNK........The FDA and the NIH specifically created 'clinical trials.gov to vcreate transparancey in teh clinical trial process. It isn't up to Korans.
And this NONSENSE of you harping that I diddn't buy at 6 cents or 15 cents. Who cares! At those prices RGRX was close to BK and it was RISK ON. RGRX is still RISK ON until I see the TRIAL DESIGNS. if the design for eye NK is largely in moderate to severe....and teh dry eye trial has for it's PRIMARY ENDPOINTS the two sunsections where we won on forst trial....then RGRX is RISK OFF. Do you get the DIFFERENCE between RISK ON and RISK OFF? I doi NOt trust Finkel, nor do I trust the FDA.. I could care LESS if I pay 50 or 60 or even 70 cents for more, as long as i know it is RISK OFF. RESTASIS is a $1 billion drug. if TB 4 works, it will blow RESTASIS away. A $1 billion drug and RGRX just over 100 million shares..coudl easily be a $10.00 stock. So what the "F" difference is it, on a $10 stock in longer term (if it works) if I buy at 40, 50 or 60 cents? IT IS MINISCULE......I DO NOT TRUST Finkel or FDA. Unytil I see the TRIAL DESIGN, all here is stuill risk on. AND THE OTHER THING??? We are at 43 cents now? the idiot MM"s have NO CLUE on trial design and how critical. if trial designs are GOOD for us, the MM's will short ALL I WANT at 50 cents or 55 cents. they will defend their short position. So I will wait for risk off. MM's will give me all I want. YOU worry about 10 to 15 cents? I don't care about 10 or 15 cents. Only way RGRX get's to $10 is a TRIAL WIN. ONLy way we get a TRIAL WIN is the EXACT RIGHT TRIAL DESIGN!! You will never admit that.
I sold my WTM around 4430...long term holder. Only a couple hundred shares. I got worried when I saw China crash.because BOTH the sale of Sirius and Symetra stock are to Chinese companies....now I see WTM down $35 to mid $690.....no reason for that..except mkt now worrying that one or both deals my not close..because the two companies severely imp[acted by crash over there. WTM probably won't go up big as I thought until they have casjh in hand..but that can't be at least till mid 1016, as insurance regulators will nee long review.
HEy bull...I own a lot already. I have bought over 30,000 more shares between .38 and .45. But until I see the trial designs, it is still risk on. If the dry eye design uses the two sub section endpoints where we won, FABULOUS! if the eye NK design ONLY uses moderate and some severe NK puts, FABULOUS!
I need to see the primary dry eye endpoint is where we won before. i do NOT want to see the eye NK only using the SEVEREST of patients and very few moderate (easier to cure) ones. It is so simple. It is RISK ON until we see trial design. if BOTH trials are designed FAVORABLE to us....then it is RISK OFF and RGRX will probably go quiclky to 60 cents. if it is RISK IS OFF, I am thrilled to pay 60 cents! Because we all know every minute detail of where we DID work.
Unfortunately, my broken record is just the TRUTH. I don't care if I pay 60 or 70 cents for shares, as long as I see the trial design is spot on. DO NOT trust Finkel of tthe FDA. I want to see the eye NK trisl designs to include mostly MODERATE to SEVERE patients. I do NOt want to see the eye NK only talkng the severest of the worst stage pts. Lower chance of success. And DRY EYE? YOU HAVE NO CLUE what the FDA demands. we know we failed in two sections, we know we got a win in two other subsecttions. If FDA approves the dry eye design to basically cover the two subsets where we worked. FABULOUS! I will pay a lot higher because a SIGNIFICANT RISk is off. If the eye NK trial only takes worst or worst eye NK (and few MODERATE patients), that's bad. If FDA does not allow to cornea subsets in dry eye, DOUBLE bad news. Everything is RISK ON till we see the design. If the designs are good and "doable" as you say....then it is RISK OFF. I am AMAZED you still trust Finkel after the Stage 4 pressure ulcer debacle. AND WHY hasn't RGRX DISCLOSED ANY OF THIS?? BECAUSE THE FDA HAS ALREADY APPROVED BOTH TRIAL DESIGNS!WHY DOES HE NOT SHOW US AFTER FDA APPROVED THEM????? IS IT ANY WONDER PRO BIOTECH INVESTORS RUN FRON FINKEL TINKEL?
I will buy more shares once RGRX has the trial designs up to see. The phase 2b/3 dry eye is critical. So is the phase 3 eye NK. The Koreans seemed to have put on the back burner the Kolrea dry eye trial. So all rides on the two USA ones for now.unless China starts sooner, which seems unlikely with the turmoil over there.
I need to see teh trial design. I need to see that the FDA acepted the two subsets of cornea where we saw great % response, but were not designated as an endpoint in trial.so all think the trial flopped. I do not trust FDA or Finkel. when I see that those two subsets are now the primary endopint in tral design, I will buy more. Same goes for eye NK. While the 6 patient early trial showed great response, what we DO NOT KNOW is if they were doesing stage 2 or 3 eye NK...we do not know what stages of eye NK the FDA wants. if stage 2 & 3 eye NK, fabulous. But if FDA demands a trial of stage 3 and stage 4....not good. REMEMBER, Finkel screwed up before. The pressure ulcer trisl was largely in stage 3 and stage 4 ulcers. stage 4 ulcers go as far down as to expose OPEN BONE AND MUSCLE. TB 4 will not cure that. The pressure ulcer trial with stage 4 puts, was DOOMED from the start. RGRX did not disclose they had many stage 4 patients. SO WHY WILL I TRUST FINKEl again? I want to see the eye NK trial design in moderate to sever puts. I do NOt want to see the design taking only the worst of the worst very sever puts. that will very much lessen chance of success. WHERE ARE TRIAL DESIGNS??? FDA has approved both. SIILENCE BY RGRX, as usual.