I doubt that RGRX will do any releases on the EB results or the heart research article. They have stopped doing PR's on research articles or abstracts.......But I am REALLY curious to the EB results posted w/ FDA - or how to read them. if 8 of 22 pts saw their wounds completely healed, with no safety or side effect issues, it would be a no brainer for a successful trial, and probably approval. 8 of 22 were totally healed..they don't state how many were partially healed also. I am sure some were. But there is ALWAYS an RGRX trial issue/problem/screw up. And EB has it. I would like it explained. How did 5 pts on a water gel placebo see healing as well? If a placebo water gel healed EB blisters, then there would never be a problem with EB that there is no drug or therpy to address it! How on earth did a water gel heal 5 pts??? And thusly, is the trial so screwed up?....and because of that that the 8 of 22 healed w/ TB 4 get thrown out? need explanations. Won't get one, IMO.
It is instructive to go to "clinicaltrials(dot)gov" and iun search box put in "ABH001", that will bring you to Shire's Phs 3 w/ 20 pts in EB. It is usual RGRX bad luck. when Shire filed thier Phs 3, they, in an unheard of move. got the FDA to allow a Phs 3 that is not blinded or placebop controlled. I wish in 2006, when RGRX started this EB, that the FDA would have allowed.What happened is that TB 4healed the wounds in 8 out of 22 - which is amazing. what screwed it up was that some on a water gel placbo also healed. But I don't see how, because there is no drug for EB....that is why they clamor for one, not water gel. So how did a benign water gel base get a response??? I hope it doesn't mess up FDA...because otherwise, TB 4 getting a complete healing and closure in 8 of 22 is an approveabe drug...and no side effects.
But go and read clinicaltrials of EB drug ABH001...and cry that teh FDA didn't allow such parameters for RGRX.
Ahhhh, maybe figured it. On feb 6, 2013 the FDA CHANGED the trial protocol AFTER the trial was done, with the important (efficacy) outcome changed to THIS:
Number of Participants Whose Wounds Have Healed [ Time Frame: 56 days ] [ Designated as safety issue: No ]
Wound healing means that the wound has closed without any drainage.
Since the trial was COMPLETED, they had to report what was found on placebo. but on Feb 6 2013 (see clinicaltrialsdotgov), the FDA basically threw OUT the placebo end of it..and the secondary outcome (efficacy) measure simply became "number of patients whose wound healed". So by that NEW FDA approved measure, TB 4 healed 8 out of 22 EB patients! A huge win. But the measure was only for wounds all closed and healed. We got 8 out of 22 healed. But they don't say how many pts got what Shire looks for in thier FDA blessed EB Phs 3, which is only a REDUCTION in wound size. I'd like to know if many pts saw a REDUCTION in wound with TB 4, but not totally healed. If TB 4 did that in many, and healed 8.... it woudl be seen as almost a miracle drug for EB kids....either cures the wound or reduces it greatly.
if this get's out and is EXPLAINED better by RGRX, our short has a HUGE problem. He is a MM, and he is "naked" short...I bet 2-3 million shares worth. Of 70,000 shares trade Friday, he shorted 55,000 - on the BID too!
Ahh, there it was , bo....In the TB 4 arm 8 out of 22 pts got total wound healing and closure. That is a huge win. because they don't state how many got "partial" and not "full" closure.
BUT?? An issue? You can also see that 5 pts got closure on the placebo. Which is odd, because the placebo is probably just some water based jelly or whatever base was used with TB 4 comparator. but there is no drug that works that for EB, otherwise it would be out there already, if a placebo gel got 5. But if a placebo gel worked, all you would need is KY Jelly to treat EB....but all we read is that it is impossible to treat?
We need more detailed info. Especially on the placebo end. However???? It was a 7 year trial. The FDA now only asks for EB an OPEN LABEL PHASE 3 approval trial (see Shire). if RGRX is held to teh open label that Shire seeks approval on...for only a REDUCTION in wound....then if TB 4 healed totally and safely 8 of 22 patents?? It is a massive success!
If teh FDA just looks at TB 4, just as they will what they approved w/ Shire.....curing 8 pf 22 is a massive win and an approveable drug. And RGRX has stated that they may keep and market TB 4 for EB 100% themselves. The pts and hospital centers to treat EB are easily reached via EB databases. Hardly any marketing/advertising needed.
Here's what the FDA okayed for Shires EB drug (called ABH001) for a 20 pts OPEN label, no placebo Phase 3:
"Primary Outcome Measures:
Reduction in wound surface area [ Time Frame: 24 weeks ] [ Designated as safety issue: No
Now compare that to the larger and better placebo controilled and blinded RGRX trial, which teh FDA allowed the trial proptocol to be changed AFTER the trial was done! The outcome for TB 4 is FAR FAR harder to achieve that what Shire tries. read:
"Number of Participants Whose Wounds Have Healed [ Time Frame: 56 days ] [ Designated as safety issue: No. Wound healing means that the wound has closed without any drainage."
See the difference? Shire only goes for a REDUCTION in wound surface area....TB 4 goes for wounds that have HEALED AND CLOSED!
TB 4 got a P value 0.05 in EB patients whose "wounds closed and healed", NOT just "reduced in size". And it was a blinded and placebo controlled trial, unlike Shires Open label Phs 3. TB4's data from trial is better done and with more pts than Shire's. So why couldn't the FDA give approval? The FDA gave it Orphan Status, and the FDA CHANGED the trial protocol AFTER the trial was done (see feb 6 2013)! Something is up (maybe) at FDA????
I wish RGRX gave more detailed data. But fact is they report a P 0.05 to FDA. That is a WIN. In Feb (as I pointed) the FDA allowed the Phse 2 to be changed to this on secondary outcome: "Number of Participants Whose Wounds Have Healed [ Time Frame: 56 days ] [ Designated as safety issue: No. Wound healing means that the wound has closed without any drainage."
If RGRX tells FDA they have a statistical P 0.05, that means they saw closed wounds in TB 4 treated pts, and it was statstically significant with no adverse effects. The FDA has in their power to approve TB 4 for EB just based on these Phs 2 results. There is NO drug that does much for EB. TB4 trial took about 6 or 7 YEARS. Shire Pharma is doing a Phase 3. the FDA approved it with ONLY 20 TOTAL pts. RGRX had 25. Shire has a Phse 3 OPEN LABEL TRIAL - unheard of by FDA, who demand always blinded & placebo controlled. RGRX's phs 2 is MORe rigoprous that Shires Phs 3, and RGRX had more pts.! When the EB parents hear of this, they will scream bloody murder as to why FDA will not allow it now to their kids! RGRX has already DONE a LARGER trial - than FDA okayed Shire Phs 3 w/ 20! And RGRX was placebo and blinded! And TB 4 got 0.05 P Value! I wish RGRX woudl SAY SOMETHING!
Great looking, donker! The results for the EB trial. RGRX didn't fill in all the details, but they had 17 pts complete TB 4 and 8 complete placebo. That is 25 total. And it was a blinded & placebo controlled trial. but RGRX did disclose that they got a P value of 0.05! Statistically that is a trial WIN! That is good enough usually for FDA. And no side effects were seen. FYI? Shire Pharma got FDA okay in Feb 2013 for a PHASE 3 EB trial with only 20 pts. And it is an OPEN LABEL trial. No placebo, no blinded. So RGRX had more pts in theirs and it was more rigorous because blinded and placebo. This is ALL real interesting. A P 0.05 is a trial win. What will RGRX do with FDA? if FDA gives Shire a Phs 3 design OPEN label w/ only 20 pts??? EB kids are suffering. if the FDA bends a bit, our massive shorty is in big trouble. A P 0.05 says that TB 4 healed EB ulcers!
FL...IMO, it is retail buying at 7 cents. We have a poster here who was loudly complaining that he had a large bid in at 7 cents, but never got a fill when the MM's printed it at 6.6 cents. IMO it is retail bidding, and the MM's are shorting the BID, not the ask. So they really bet on RGRX going down.
the short we have is a Market MAker, and he is exempt from reporting his short positon in RGRX. Teh SEC thinks there is only 5,000 short in RGRX. Actually the real short postion is closer to 3 million shares I bet. he shorted 55,000 shares alone on Friday. teh MM is playing that RGRX is bankrupt and goes to zero.
Our short is getting more aggressive. Of a little over 70,000 traded Fri, he shorted 55,000 shares. I think around 7 cents.Check FINRA stats. They seem confident that RGRX going BK. But teh SEC still reports only about 5,000 short??
It's not illegal if you do what you did, buy stock near close. You're just "retail". Where the SEC takes a real dim view is when institutional types do a "mark up" (or if a short fund mark down)...of holdings on the very last day of a quarter.or even last trading day of year. They just mark up for thei9r quarterly reports, artificially..
The MM will mark down too. But he just seems to do so during the day, and not near the close - so he does nothing illegal. He puts low small prints (usually in morning) to try and beget more selling - which doesn't seem to come.
I agree with other poster. It's kind of futile to do this, unless you really want to but more RGRX.
How'd ya' find that release, donk.....the money was granted last Friday. No word from RGRX about it. Sure would be nice if they did a small physician sponsored trial....in diabetics....but my hunch is it's probably not.....just pre clinical stuuf. Kudos to Henry ford for seeking out the grant:
"Today, the Department of Health and Human Services reached a decision to grant more than $318,000 to the Henry Ford Health System to research diabetes. The National Institute of Diabetes and Digestive and Kidney Disease authorized the funds for Diabetes, Endocrinology and Metabolic Research, the results of which could provide the opportunity to better aid diabetics in their recovery. Specifically, the grant project will focus its research on Thymosin Beta-4, a protein which promotes the recovery of peripheral neuropathy in Type II diabetics. "
Hey, happens all the time. why would anyone pay a premium, or even anything, for RGRX now.....when it could basically be all but free after a bankruptcy. We know the drug rights go back tto NIH, and they would be happy to give them right out again. but I don't know who would get the patents that RGRX themselves have gotten. I don't think the NIH gets them. I assume a bankruptcy court might sell/auction them?
A poster here..john__j.....gave a very plausible scenario as to why. his point was that Mgmt and BOD were just going CAREFULLy thru the motions, so they could take RGRX BK....and his thought is that they do so on purpose so mgmt and ST can bascially get all of it back for free, soon after. When RGRX goes BK..TB 4 goes bacjk to NIH, and NIH will turn ariound and give it to any new entity (ST and mgmt) that will proceed w it.
Only issues is shareholders SUING mgmt and ST after they do that (if they do that). So that is why (maybe) they do several band aid fiunancings to make it appear they did their hardest. A judge can't argue then.
This was just the posters idea. And there is logic in it, have to admit.
Like I said in earlier post, it just doesn't add up. I am sure that the Dry eye experts at Ora Inc were made aware of these results, even though Ora didn't do it. but it adds to the body of work, in HUMANS, that can be show to pharma. And the results aren't bad.. So why is it, Ora Inc doesn't care....why is it not a single drug starved pharma cares....and they have all the money in the world to spend to find new drugs. RGRX can't even get a few million $ gamble from a pharma. TB 4 is unique in that there is NO safety or side effect risks. That is a HUGE plus. No one cares. Ora Inc has the deep contacts to get TB 4 partnered. And Ora would benefit by then getting another Phs 2b, and if warranted, a large phs 3 with it.. But no one cares - and that means we are missing something pretty big...there must be a reason no one wants it....and that is that they don't think it will work. I woudl LOVE to hear from George Ousler's lips (head of Ora dry eye unit).....WHY? I would pay for what he knows. Save us the heartache and what mgmt will NOT tell us.
I agree w/ you. But where is ORA Inc in all this. They knew the trial results. It was just bad luck where they chose the endpoints. Others areas in the eye did get statistical result. SO? why hasn't Ora been able to tell that to others? Ora deals with just about every major pharma for trials and research. Ora knows ALL the players. And these players and pharma trust Ora's work. Ora did get statistical success w/ TB4, but not where they thought they would. So why is TB 4 just ignored? Pharma is starving for new drug prospects and they have billions to spend. I just don't get it. It does not add up.
a certainly plausible scenario of yours. But I know of a strong Wash DC lawyer who owns a lot of this (as do acquaintances of his), and if it looks like ST and mgmt were in "cahoots" to let it go BK, so then mgmt & BOD and ST could "steal" the carcass...could raise legal issues soon down the road. Mgmt and BOD have a clear FIDUCIARY duty to shareholders. If Mgmt and BOD and ST plot to BK the company, to steal assets, then own it all themselves soon after... there is a big lawsuit just waiting there. And since ST is a Billion dollar company, theres money to go after. Thats what lawyers LOVE.
I wouldn't really count on Sigma Tau "rescuing" RGRX. Because if ST had that intention, they would have chipped in some money in the latest $225,000 "Band Aid" financing. I think it a telling sign, by their abscence of a single penny into it....that ST is not going to rescue RGRX - at least in a way you hope would benefit us.
There won't be much left for mgmt to "cherrypick" if RGRX goes BK..because if they do, all rights to TB 4 revert back to the NIH. But i'm sure the NIH woudl license those rights back to anyone who would continue TB 4 work. I don't know who would get the patents RGRX has. But even if mgmt is planning a BK move, to steal assets, what the heck would they do with them? They don't have $$ for trials and they have NEVER been able to get a partner or large investor with $$$ to put in, to do trials. So they are back where they are now.... anyways. Mgmt is better off with RGRX as a surviving entity. I don't know how they'll do it though.
No, the SEC would care. It isn't the AMOUNT of money that matters. the MM is breaking the law. The SEC has strict rules that most Market makers flout. it is why you get all this talk about naked shorting. MM's are ALLOWED to NAKED SHORT as long as it is in the "ordinary course of market making". which means they make bids and offers and they buy/sell/buy/sell....on a daily basis. if you DO that a MM is exempt from ALL the SEC short sale rules. They can short naked. they don't have to borrow shares. they don't have to report ANy shorts sales to the SEC, just FINRA. But the SEC rules are clear...you CANNOt take a large position in any stock, long or short and keep it in your account....IF THAT holding is a longer term POSITION TRADE....and not a daily buy/sel/buy/sell. Our lead MM, NITE, is breaking SEC rules by being short a huge amount of stock (I bet) and not reporting.. The ABUSE the SEC tries to protect from is a MM just shorting to oblivion and no one knowing. Our MM NITE has a very large short position and they abuse the rules. We traded 15,00 shares yesterday? The MM shorted 12,000. he will do what he has to do to keep REGRX down....to defend his SHORT POSITION TRADE..not to make a buy/sell market.
I hope there is news sometime and they get killed.