This is potentially very good news if TB 4 ever get's dry eye approval. If court decision holds, it will al;ow TB 4 to also be marketed to people after LASIK surgery and other areas of eyes, and after surgery on them...without the FDA approval they insist you need off label.
"A federal court in New York delivered a setback to the Food and Drug Administration, ruling the agency can’t bar a drug company from marketing a pill for off-label use as long as the claims are truthful. The decision by the federal district court in the Southern District of New York, is the latest of a line of such cases. It concerns the Irish company Amarin Pharma Inc. and its fish-oil-derived drug Vascepa, and it has been closely watched by the pharmaceutical industry. The company asked the court to stop the FDA from enforcing its off-label marketing ban, and the court agreed. The ruling means Amarin can give doctors and others truthful accounts of medical studies of the drug for reducing moderately high blood fats even when the FDA hasn’t approved it for such use. The FDA has contended that such off-label marketing isn’t lawful, but recent court decisions have held that the First Amendment restricts the FDA’s power to limit truthful speech. U.S. District Judge Paul A. Engelmayer ruled that Amarin “may engage in truthful and non-misleading speech promoting the off-label use of Vascepa.” More specifically, he ruled, disseminating such information cannot serve as the basis for the FDA or the government to charge the company and its sales personnel. He said the First Amendment allows the company to make such statements, if they are truthful and not misleading.
Go back and read the examiners rejection previous to this. ALL he talks about is Mr. Straser, who in 1983 file thymosin for Sjogren's disease. He rejected RGRX because he said that Strasser anticipated it first. But he filed only for Sjogrens disease. BUT TODAY? read the logic for rejection. The examiner now never mentions 1983 Strasser! BUT THAT WAS HIS WHOLE REASON FOR REJECTING PREVIOUSLY! So now, the examioner comes up with a whole new reason NEVER MENTIONED BEFORE, and that is Goldstein anticipated it first in a 2003 filing. WHAT HAPPENED TO STRASSER BEING FIRST IN 1983? But Goldstein is BOTH on the 2003 patent and the latests. (BOTH REJECTED!!!) BOTH GOLDSTEIN and both TB 4. I hope RGRX goes to court on this idiot examiner. it is like he is being paid off. Charles Dickens hated patent offices too..in one of his books he nailed them by giving their patent office the term, 'The Circumlocution Office"....talking in circles they do. the examiner today is talkingin circles. First rejcts us because of Strasser, but now 1983 Stasser is no where mentioned again. now he rejects because of 2003 Goldstein? Talking in circles. Criminal almost.
The China trial is very important here, because I don't think the US trials will be starting anytime soon. A trial win is what will get RGRX going. Koreans buy the HYPE of G Tree...USA investors RUN AWAY from Fnkel and RGRX....we are now a $39 million market cap compared to G Tree $300 million.
it is a legitimate question to ask. WHAT is going in in China trial? The deal was signed with Lee's THREE YEARS AGO. Chinese gave prelim okay on the trial filing ONE YEAR AGO. We have a right to know. What scared me was that a poster here emailed Lee's and they did NOT respond. He then emaild Finkelstein , and he DID NOT RESPOND. Usually all of investors relation types have a spin answer for you that tells you really nothing. But it was the fact that neither Lee's investor relations or Finkelstein........would answer a query about the China trial. So when I add that up...and three years wait...and over ones years delay since initial trialokay........then we all have every right to wonder what is going on. When Lee's refuses to answer, even with a "stock answer" reply.......there is a reason they don't.
Arghh.Who turned the lights on! the cockroaches came out!
You are one smart cookie, or at least you think so. YUP! RGRX went from 15 cents to the high 50 cent range. Absolute fact.
On JANUARY 30, RGRX was at 15 cents a share. On MAY 5 RGRX closed at 57 cents a share. So that is a 42 cent move? is that the supposed PUMP? if so, let's look for the dump side. from MAY 5 to now.....JUNE 12...RGRX goes from 57 cents to 33 cents. Yup, a fact.
But there is just one teenie weenie problem. Between JANUARY 30 and MAY 5....RGRX traded 10,591,695 shares. That is the pump? 10.5 MILLION SHARES WORTH? But if a pump, the dump always comes after? Hum......I see today that 19,000 shares have traded......that's it.....19,000....if the pumpers bought 10.59 million on the pump, I woudl expect a large amount to now be dumped. Unfortunately.........19,000 shares doesn't qualigy against the 10.59 million.
Nice try though.
I think the rules are different on OTC BB stocks. Nasdaq national mkt different. Still pretty amazing. 176,000 shorted of 278,000 traded. They are making a huge bet against TB 4 that RGRX is a penny stock POS. They've got to be over 3 million short as a position trade by now, It has gone on like this for years. The rule infraction with SEC is that the MM are not allowed to naked short w/o borrowing for long term POSITION trades. the MM only get's the MM exemption for not borrowing or reporting their short for "ordinary course of daily business" market making. when you see the MM shorting 60% or 70% of a days volume, it is not ordinary market making.but using thier power as a large POSITION trade short. Position trades do not qualify for MM short exemptions as I understand. But they have cheated that rule for years now.
Here are snippets of heart abstract. Seems like they are going after using TB 4 AFTER the heart attack. Sionvce TB 4 is totally safe, it won't be too hard to find patiemts for a trial:
"Repairing defective cardiac cells is important towards improving heart function. Due to the frequency and severity of ischemic heart disease, management of patients featuring this type of cardiac failure receives significant interest. Previously we discovered Thymosin β4 (TB4), a 43 amino-acid secreted actin sequestering peptide, is beneficial for myocardial cell survival and coronary re-growth after infarction in adult mammals. Considering the regenerative potential of full-length TB4 in the heart, and that minimal structural variations alter TB4's influence on actin assembly and cell movement, we investigated how various TB4 domains affect cardiac cell behavior and post-ischemic mammalian heart function. ..... Our comprehensive domain investigations also suggest, preservation and/or restoration of cardiomyocyte communication is a target of TB4 and AGES, and critical to improve post-ischemic heart function in pigs. In summary, we identified the C-terminal four amino-acid variable end of TB4 as the essential and responsible domain for the molecule's full benefits in the hypoxic heart. Additionally, we introduced AGES as a novel, systemically applicable drug candidate to aid cardiac infarction in adult mammals.
Dow down 358 yesterday and 516 today....that about 875 points lost in 2 days. RGRX does minimal volume.....a good bit of it shorted to buyers......sellers are negliable here....pretty much a 43 cent to 45 cent range. Pretty amazing, if you ask me. I'm sure MM's wanted it down, but really there aren't that many sellers. And I know a lot of us here are bidding below.
Nice feeling.....NOW..WHERE ARE THE DAMNED TRIAL DESIGNS on clinical trials.gov! Supposedly the FDA HAS APPROVED THE TRIAL DESIGN......I just won't buy much more RGRX UNTIL I SEE THE TRIAL DESIGN....The FDA can still SCREW us if they do not allow in as Primary the two tiny sub sets we saw in first Ora trial. It is CRITICAL that those two subset endpoints become the PRIMARY ones for this trial. I don't trust Finkel or FDA. Show me first.
I hope all is well with G Tree........high was around 16,000.........it's now at 9,950 But they mae no sense. Why pay up for a TB 4 leg or arm whne the WHOLE cow of TB 4 is 40 cents in RGRX.
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."
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!
B7...quote, ".I wait on news."
You will have a long wait I'm afraid. Lee's is not talking anything of the endless delay for China eye trial.and it is three years after we signed a "partner" deal. You hoped for conference news? the conferences RGRX paid to get into are all but worthless. We are down about 18 cents since he "presented" at such. Abstracts, no matter what.are worthless. There are hundreds of them on TB 4. what good are they? they all are just pre clinical.
Maybe now you realize that there is only ONE bit of news that will help. getting a trial..ANY trial..started. Lee's is not talking and seemingly stalling. G Tree is not talking. RGRX is not talking..Finkel is just saying he does not "know".and that he "hopes" by end of year. Seems to me? if I was CEO? I woudl be in a helluva lot more contact with Lee's and G Tree...so I could say something about how planning progresses. Basically? Finkel is Sargant Shutlz from the TV show 'Hogan's Hero's"......." I know NOTHING." That's why RGRX is where it is....
Not all true. It is GGtree's first foray into an actual drug, but G tree did hire an experienced pharma exec as co-ceo........and supposedly this guy pulled in a few other seasoned people..probably as consulting stuff for now. Hyandai Securities is a big firm. The had to have met and sat down w/ mgmt. G Tree surprised me, I will admit. Wasn't expecting either the good hire, swift and easy fundraising (inclding FREE $7 million from gov't).....nor did I expect then to get a $375 million market cap in just a few months.
Thanks for sharing, but no one cares anymore WHAT RGRX throws out into the press. Once burned thrice learned...After 20-55 years of hundreds and hundreds of similar great reading abstracts...what has changed? Nothing --- except RGRX was almost bankrupt.....they've #$%$ thru close to $100 million..and we have a 30 cent stock. Same old.... same old. waiting and waiting and waiting on another trial.. THE ONLY THING THAT CAN CHANGE RGRX IS GETTING THE F TRIALS STARTED. Seems like Lee's in China is taking RGRX for a ride.
Typical RGRX. The PAtent Ofice granted FINALLY RGRX another USA patent in heart area. Preyy big. HAppened in mid June. RGRX is silent and not disclosing this.
The Henry Ford patent os okay, but RGRX already has a close neuro one issued previously. Gues smore is better. This will aid Dr. Chopp if he has any ideas for a partner. He has a good reputation. But no pharma is really interested unless you got teh patent protection. So right now, we have TWO in neuro are (with HF) and I think three in the heart area.
The LATEST heart patent was FILED IN 2001. That shows you how much of an SOB the USPO os......FOURTEEN YEARS OF FIGHTING THEM, and now they gove in.
If you want to look, the patenet publication number is 20040258680
RGRX received this THREE weeks ago and it hiding it.
Read this from the SEC itself. RGRX is being scammed. Has been for years. Clear violation of SEC rules. READ:
"We are adopting the proposed exception from the uniform "locate" requirement, as Rule 203(b)(2)(iii), for short sales executed by market makers, as defined in Section 3(a)(38) of the Exchange Act,66 including specialists and options market makers, but only in connection with bona-fide market making activities.67 Bona-fide market making does not include activity that is related to speculative selling strategies or investment purposes of the broker-dealer and is disproportionate to the usual market making patterns or practices of the broker-dealer in that security. In addition, where a market maker posts continually at or near the best offer, but does not also post at or near the best bid, the market maker's activities would not generally qualify as bona-fide market making for purposes of the exception.68 Further, bona-fide market making does not include transactions whereby a market maker enters into an arrangement with another broker-dealer or customer in an attempt to use the market maker's exception for the purpose of avoiding compliance with Rule 203(b)(1) by the other broker-dealer or customer."
You've really got a bone up your butt, don't you..... bo.
ALL I DID was respond to teacher, on this ONE sentance he wrote!
"...TB-4 being shipped to the US it's important to note that the FDA will look upon the results in a more favorable way that if they were done overseas."
So WHT is your problem! All I replied was that TB 4 IS NOT BEING MADE OVERSEAS, as this poster wrote. TB 4 is NOT BEING SHIPPED to the US!
Secons, the guy wrote that teh FDA woudl not look "as favorably."if they were done overseas". All I did was state the FACT that the FDA doesn't have jurisdiction overseas, and they really don't care. They care about USA trials. Period.
So get off your high horse. I am right. TB 4 is NOT BEING SHIPPED INTO USA DFOR TRIALS....and the FDA doesn't reallu\y care about foreign trials TOTALLY OUT OF THEIR REGULATORY SPHERE!
THat bump was me. I took all remaining stock at .40....then for fun to see what MM woudl do I added a market order. Some again at .40 but then I was kind of surprised he filled 4,279 at .45.......5 cents up. No big deal really.....but I was surprised the 5 cent spread from .40......no other MM was offering or playing.
MM will probably trade it down a bit.....I bet he shorted what I bought. But Sept is coming and I don't see it going much below .40....overall market has had a big whack.and sellers really weren't much here.
I wish if the US dry eye has okay from FDA they would put it up on clinicaltrials.org. I need to see trial design. I bet some others are waiting on that too.
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.
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.
Good news the phs 3 is okay to go. But this one will take a lot longer than dry eye. I doubt we see results till very late 2016 or even 2017. And I STILl want to see the TRIAL DESIGN. Why? I checked clinical trials, and there is started earlier this year a phs2 NK by "Dompe Pharmaceuticals" (foreign). they have locked up a dozen of the best eye places in USA, including the best in Boston. Pts are scarce. Which means it will be harder for Ora to get pts, and Dompe is already recruiting. SECOND! Dompe is clear in design they will only accept Stage 2 and Stage 3 NK ulcers. RING A BELL? Remembert Finkel boob signing up INCURABLE STAGE 4 pressure ulcer pts? he did stage 3 and 4. NOT stage 2 and 3. we flopped. So I DAMN well want to see NK trial design to make sure Finkel does not take in far harder stage 4 again. HERE is the trial design Dompe for thier NK trial. I NEED TO COMAPRE IT TO TB4's. Will Finkel repeat his mistakes?
"Primary Outcome Measures:
Complete healing of the PED or corneal ulcer [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Percentage of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining at 8 weeks as defined by the central reading center on clinical pictures
Secondary Outcome Measures:
Improvement in visual acuity [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Mean change in BCDVA from baseline to Week 8. Analysis of variance will be used to compare the mean change between treatment groups.
Percentage of patients that achieve a 15 letter gain in BCDVA at 4, 6 and 8 weeks. Treatment will be compared at each time point by means of Chi-square test."