Jujst read the reply from examiner. total IDIOCY. And I am not a lawyer. The examiner changes the rules as he goes. His first rejection was basically because he found someone in 1983 who mentioned Thymosin as a treatment for Sjogrens disease, which causes many issues throughout the body. One possible effect of sjoigrens is dry eye. So this dope examiner rejected RGRX latest claims because of this 1983. However? in the reply TODAY..., the examiner NEVER ONCE MENTIONED this 1983 patent that he held so NEGATIVELY previous! But NOW this examiner brings back a whole 'nother reason to reject, and that is in 2003 Goldstein applied for one similra for eyes, mentioned dry eye. but from 2003 to 2010 the USPO REJECTED IT! RGRX gave up. So they tweeked it to the latest filing, now also rejected. But the IDIOT says that the very 2003 application, whch THEY REJECTED, now holds precendance over this latest one. First to file. He rejected the latest because GOLDSTEIN taught it earlier in the 2003 filing. BUT GOLDSTEIN is on the filing for the just rejected one! GOLDSTEIN IS THE NAME ON BOTH and RGRX is assigned both the good news is that no one can step over RGRX now because the examiner syas Goldstein was first to file. but we still don't have it issued. I hope RGRX goes to court if they can. BOTH filings were GOLDSTEIN!
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.
Not oiver yet. What a #$%$. IMO? The first rejections was based on 1983 Straser filing. but teh LATEST rejection based on 2003 Goldstein filing. Thus, rejection is based on NEW theory. USPO states this on that situation or NEW theory rejection:
"An examiner's answer may include a new ground of rejection. For purposes of the examiner's answer, any rejection that relies upon any Evidence not relied upon in the Office action from which the appeal is taken (as modified by any advisory action) shall be designated by the primary examiner as a new ground of rejection. The examiner must obtain the approval of the Director to furnish an answer that includes a new ground of rejection.
Appellant's response to new ground of rejection. If an examiner’s answer contains a rejection designated as a new ground of rejection, appellant must within two months from the date of the examiner’s answer exercise one of the following two options to avoid sua sponte dismissal of the appeal as to the claims subject to the new ground of rejection: "
Then after they try that, it is time to try and fry the USPO in court. RGRX can exit the USPO and take it to the Federal Court OUTSIDE for a fair hearing. If they go this route, they have 63 days to file they wish to take USPO to Federal Court
"EXAMINATIONS.—An applicant who is dissatisfied with the final decision in an appeal to the Patent Trial and Appeal Board under section 134(a) may appeal the Board’s decision to the United States Court of Appeals for the Federal Circuit.
The time for filing a notice of a 35 U.S.C. 141 appeal to the U.S. Court of Appeals for the Federal Circuit or for commencing a civil action under 35 U.S.C. 145 is within 63 days of the Board’s decision. "
The pain in heh neck is you in the mirror! WAKE UP! RGRX is dioing exactly what I said it woudl when YOU hyped up the coming magic of conferences. I said the MM will let it up so confernce fools buy......then after the MM will take it right back to where it was before. BINGO! A 43 cent trade now? SEE??? When will you WAKE UP? PR's mean nothing.....penny stock bio conferences, where RGRX PAYS TO SPEAK probably.......carry little weight in investment community....new pre clinical abstracts mean little or nothing....just a hype and a dream.....there probably are obver 500 abstracts on TB 4 already and we are still 44 cents. What good have they done? NOTHING! There's only ONE thing to get RGRX stock zooming. A trial win. And we can't get a potential trial win UNTIL THE CHINA TRIAL STARTS! So why don't you focus your energy on that! EMAIL Finkel! CALL Finkel..even better? EMAIL LEE"S Pharm in hong Kong. They have an investp[r releation email addres I am sure. but for gosh sake.wake up. TRIAL WIN and CHINA will rule the day...not PR, not news, not an conference.
I have no idea if RGRX will be at $1.00 in a years time. It WILL NOT get to $1 based soley on a PR, news ittem, new pre clinical abstracts or any tiny spec biotech conference they attend. But what COULD get RGRX above $1.perhaps WELL above $1 is a clinical trial WIN.
How often do I have to say it/ RGRX... has flogged and touted TB 4 since the late 1980's..almost 25 years now. How has that gone for us? There is only one thing to get RGRX to a $1 or over. Trial win...trial win...trial win. Period. end of Story.
Ignore B7 and his daily sillies. TRIAL WIN. And we cannot even think of a possible trial win, unles the trial STARTS! China is first up and I think BEST chance of a win....simply because of the massive pollution on mainland ...where placebos won't do much. but we have NO CLUE what is going on or when it will start. It is over a YEAR since preliminary approval. No final yet. And we DO NOT know if Lee's trial is in Hong Kong or Mainland......Beijing is BEST!
$1 dreams will not come without a trial win. Once teh China trial starts, that's when you gamble if you want.....5-6 months.
I am not so sure about that.you think:
"I doubt they can take uspto to court- too expensive."
Do not forget that G Gtree basically controls TB 4 for eye areas and skin. G Tree has invested a lot. G Tree has been hyped in korea up to a $200 million market cap now. G Tree's biggst play is in DRY EYE....G Tree has majority rights of dry eye via the JV. A couple hundred thousand to take the USPO to Federal Court woudl be money well spent for G Tree..and who knows.....The USPO does not relish going to Federal Court either. It looks REAL bad for them....and if they LOSE in Court it looks REALLY REALLY REALLY bad for USPO....since they have been rejecting RHRX patent filings for TWO DECADES........the USPO has put RGRX thru hell. So yeah.....If it comes to it..I think G Tree will be forced to protect their interests in court. And filing a Federal Court appeal may then force the USPO to come to "an accommodation" settlement before they risk court and reputation. But RGRX and G Gtree have to be willing to make that play..Bluff or not.
I've never heard of such a thing. Sounds kind of far fetched.. SEB traded about 25,000 shares in Q1. Net Net in Q1, institutions reduced their SEB ownership by 852 shares. There are about 8 or 9 thousand shares traded, that I've no clue where they went. Not to any institution that files.....retail doesn't have that kind of money.....and SEB did not buy back a single share in Q1. So who bought? Market makers don't risk carrying that kind of inventory. We know there were sellers.
another liar in hollis. All is not lost. regardles of patent or not, if teh FDA approves TB 4 dry eye, RGRX get's AN AUTOMATIC FIVE YEARS EXCLUSIVITY. So dopes read this:
"How can a drug innovator have exclusivity in the United States without a patent? The FDA will give a five year exclusivity period for a new chemical entity (NCE) used in a drug. What does this mean? During this five year exclusivity period, no other company can submit an Abbreviated New Drug Application (ANDA) to the FDA seeking approval of a drug product containing the NCE. This exclusivity period rewards the innovator for all of the research and development effort, including expensive clinical tests to show the safety and efficacy of the NCE that must be done to support a New Drug Application (NDA). The five year exclusivity period allows the NDA holder to recoup this investment. Importantly, this exclusivity occurs regardless of whether or not a U.S. patent has been issued. "
Hollis is again full of junk. He refers to Goldstein's prior art as rejection, and he hypes RGRX will never get a patent. i showed you all that in the FIRST rejection by examiner all he could talk about was PRIOR ART in the 1983 Strasser thymosin application for Sjogrens disease (IT WAS NOT dry eye). That was the main reason examiner rejected. RGRX addressed ALL that in their reply. On the appeal and subsequent rejection again, the examiner NEVER MENTIONED STRASSER 1983 (so I assume RGRX WAS RIGHT!), but he made up a new roadblosk in a 2003 TB 4 applcaition by Goldstein for all eye diseases. RGRX fought that for 7 years, and it was rejected. RGRX walked away and re filed a tweeked application in 2011. the latest one. GOLDSTEIN IS ON BOTH applications rejected. So GOLDSTEIN IS BOTH PRIOR ARTS. If all does go well and TB 4 is ever approved for dry eye in USA.I figure it is about TWO YEARS OUT. and if the FDA ever approves, RGRX get's FIVES YEARS EXCLUSIVITY REGARDLESS of patent or not. So that adds up to SEVEN YEARS RGRX and G Tree can fine tune the dry eye patent stuff. SEVEN YEARS to get it right, and FIVE YEARS AUTOMATIC PROTECTION. So hollis and bonkers can just stuff it.
NO NO NO NO......NO ONE can step in over RGRX now to file for TB 4 in eny eye area. because RGRX has first to file in 2003 for broad based eye disease, in 2011 they filed for TB4 in dry eye. A year ago, RGRX was AWADRED A US PATENt for TB 4 in Glaucoma. SO YOU SEE? USPO granted TB 4 patent in glaucoma. what RGRX has to do is tweek and file again until they get the satisfaction of the examiner. We don't know how long it will take. I just mentioned 2 years, because if TB 4 ever worked well enough, it will take about 2 years before the final FDA meeting for possible approval. if ever approved, RGRX get's FIVE years automatci exclusive after approval, regardless of patent or not. So RGRX has about SEVEN YEARS to get the dry eye right. Again! USPO granted TB 4 patent for glaucoma....they just have to tweek it to get dry eye right. In meantime NO ONE can do anything towards filing TB 4 eye patents because RGRX IS CLEARLY FIRST IN LINE OF PRIORITY! Goldstein has DISCLOSED all PRIOR ART ahead of anyone else! They have been rejected, but RGRX will keep at it till they satisfy what ewxaminer wishes, imo.
It's crazy. G Tree now has a market cap around $210 to $220 million. But RGRX owns the majority of all TB 4 rights.......or has a JV with G Tree. G Tree is on a "mo-mo hype up". In actuality....if the Koreans believe the mo-mo hype...they should be loading up on RGRX at 45 cents with a $45 million market cap. RGRX still controls 100% of ALL Europe rights for eyes....and RGRX controls ALL the heart and neuro areas....and any other place it could be used. Koreans can easily buy stocks in the USA. But I guess the mo mo hype in G Tree is good. Higher market cap, better the chance they raise $$$$ by selling equity.....and the $$$ they can raise could go to a similar JV for heart and neuro.......which is good for us...but I would think they'd wait till they see what comes out of China. If that trial works, I bet G Tree will be all over RGRX for other JV's.
G Tree sold the "film production" business...and teh technology part made very little money previously. G Tree is all up on pure TB 4 hype.
Most of us here already have a lot of stock already. Some at a loos, like me. But I did but enough to get my basis down to 0.55 to 0.58. But considering the torture and years.....I ain't thrilled....but close to the vaunted break even. Go ahead and chest thump all you like. At this stage, RGRX mgmt already put us thru 25 years of #$%$.. Dry eye is the best chance..it is a DIRECT application into an already moistened eye ball. TB 4 into heart or neuro will have to be a full body injection.....and a lot shorter efficacy life. Eye ball and cornea is a DIRECT hit of TB 4.
So why shoudl I buy? I'm happy to buy more. I'm happy to pay a lot higher than 45 cents. few people trust Finkel though. China trial is KEY to success. It does not make me feel good that right now it is ONE YEAR since the Chinese gov't gave preliminary go for trial. So WHY a FULL YEAR for final? Is anything wrong? is it Chinese gov't? Is it Lee's WE DO NOT know. Lee's originally signed the TB 4 eye in 2012!!!. THAT IS THREE YEARS OF WAITING!
Second, I have learned my lessomn the HARD WAY with RGRX. I need to see the TOTAL TRIAL DESIGN AND ENDPOINTS going forward. Beijing is FULL of pollution. 21% of Beijing population suffers dry eye. YOU as a chest thumper have NO IDEA where the China trial will be, DO YOU? If a lot of it is done in Beijing...FABULOUS! if the China trail is done in Hong Koong..NOT SO FABULOUS. Hong Kong is on the water and far less pollustion. Furthermore, DO YOU KNOW THE TRIAL DESIGN? RGRX has screwed UP trial design, or had BAD execution of trial (EB)...or bad luck chosing endpoints (first Ora trial).
Bottom line is I bet many others feel like me. We know about TB 4. But no one trusts RGRX mgmt. From here on we need to see TRIAL DESIGN UP FRONT..we need to evaluate ENDPOINTS....and we NEED TO KNOW IF CHINA TRIAL IS IN BEIJING!. I'l be HAPPY to pay DOUBLE where RGRX trades for now.if I could get some honest answers as to what is going on, why the delay, where is China trial.
Why do you bother to read donk? Joke. What is this junk about cheap manufacture in China? You got it wrong. the Chinese do not want their drugs made in China. They really want western drugs. Because the average Chinese knows thier stuff isn't as good, and even sometimes dangerous.. That's why they pay $650 for a real I phone, when they see klnock offs for $50. It's also why TA-1 in China, even tho' it has no patents left, still get's majority of sales via SCLN & western made drug. There are generics of TA-1 , Chinese mades..., but Chinese don't want them if they can afford western. Lee's should be making TA-1. Or someone else could get western made TA-1 generic, sell for 50% less than SCLN, and still make a very nice $$ profit. SCLN svrews Chinese for over priced NO patent left drug.MAybe RGRX should do that. Goldstein knows TA-1. He started it! RGRX could eaasily sell western made generic TA-1 (thru Lee's) in China and use the fact that Goldstein invented it in first place. He's Father of Thymosins!
Second? You are wrong to get excited about China from a profit point of view. The deal RGRX has with Lee's is that RGRX will get little in royalty percentage. And the upfront or milestones aren't that big either. If approved ever, it could build up over time. But a single digit % royalty is no home run when you consider that Lee;'s will keep 90% (or more) of revenue. what China IS IMPORTANT for is to hopefully be the FIRST trial to show that TB 4 works in dry eye....and get a good P value to prove it. With that, Ora and G Tree will finalize teh USA trials and THAT is what Investors buy on....a possible USA approval. ALSO? if China trial WINS.....others will come to RGRX to buy or partner the EUROPEAN RIGHTS to TB 4, which RGRX still owns 100% OF! Worry about China TRIAl..not about "made in China" ;ower costs or single digit royalty RGRX may or may not get. RGRX gave Lee's a very sweetheart deal, but RGRX was all but broke and had no choice.
Oh, and one more thing. if you read the deal structure that RGRX did with Lee's..in terms of TB 4....the agreement says that if ever approved RGRX will supply all the TB 4. that would be good. extra $$ for RGRX. However, the contract it also states that Lee's has the right to manufacture their own TB 4, is they so wish to...that woudldcut RGRX out of the supply side.. Also teh deal is set up so that RGRX get's NO milestone money from Lee's until there is actiula dollar sales of TB 4. Which isn't so good for us. Often you see milestone payments BEFOREHAND....like a milestone is paid when a Phase 3 starts.or a milestone when a drug files for FDA approval...or when a drug is approved by FDA....you get milestone. RGRX get's nothing...ahead. they only get a milestone payment when actual TB 4 sales reach into the tens of millions $ from Lee's. then RGRX get's a "milestone". Not before.
OMG, you just don't get it! The average person in China knows that their knockoff quality of any good or drug, isn't as good or safe as western made productss. It is 100% why SCLN still makes money. TA-1 has no patent proteection left in China. There are generic makers of TA-1 in China......but it is still teh WESTERN TA-1 that stays in demand. Furthermore, the largest purchaser of drugs is actually the Chinese gov't for their formulary and the Military and for all politcail officials (they don't use Chinesee made drugs)! they buy WESTERN made drugs, not Chinese knockoffs. RGRX will get no advantage from TB 4 made in China. If Lee's decides to, they will make it in Hong Kong.
Next? You have to be off your rocker if you think that when or IF TB 4 get's USA approval......that G Tree or any other big pharma that coudl but it from G Tree.WILL EVER HAVE IT MADE IN CHINA TO SELL IT IN THE USA...! No way. delusional. never happen. FYI? Our FDA isn't in charge of China mfg inspections and quality control is not good for the most part.. I don't know what donk dope is saying, but don't listen!
To create the kind of action as seen in G Tree, it's pretty clear that G Tree is talking more to investors over there. It is pure momentum. I think what coudl be driving is that G Tree is saying things go well w/ the US FDA in terms of getting trials designed for FDA review. And Ora is involved. I think the first one to go will be the Eye NK Orphan Phase 3.....being an Orphan status means a smaller pt number and FDA is more flexinble compared to the rigors they force on regular trials. So I think G Tree is probably letting on that things are progressing well with design and Ora and FDA input? who knows. But I think it pretty obvious that G Tree talks more to investors than Finkel does.
This is interesting. I just checked website "clinical trials(dot)gov to see if any thing listed new for TB 4. Go to site. I just typed in thymosin. responses showed that clinicaltrials(dot)gov also shows all Thymosin trials (TA-1) that are being done in CHINA. Go look. So this means that I assume when Lee's get's final approval for their TB 4 dry eye China, it will also show up on the site so we can know all the trial info? It is a real help if we can acces the FDA site to see the China trial design. but what we don't know is why the hold up. It has ben a year since preliminary "go". Is it Lee's or gov't that stalls??
I think RGRX is paying the 'PR" team $30,000....probably some of that was used to get RGRX into these two small conferences. You "pay to play"..i.e......we had to pay tio be able to get in, and teh PR firm handled that. The PR firm probably works on some kind or release, but they wait till real news they can run with. A new abstract isn't going to do it. But starting the China trial woudl be news they can run with.