Well, Finkel picked them yet again.not quiite as bad as a PIPE deal, but not far off it. Sabby is a real penny stock player, and they have been in trouble with the SEC before. but the BAD news is just how their firm is described:
"Sabby Capital is an activist investment firm that predominantly invests in warrants of small cap healthcare companies."
Sabby also touts their 'VOLATILITY" fund. read this again:
"....investment firm that predominantly invests in warrants of small cap healthcare companies."
So what does that point to" It sure reads to me like they buy a ton of stock, deeply discounted.then they try to trade OUT of teh stock over time, from that low discountd price and try to make a profit off that. but then if they can do that....even for a breal een or small profit.what teh VOLATILTY fund they hype is then left holdimng millions of warrants in tons of companies.....and the warrants are free and they traded out of some stock. A home run if just some of them ever "hit".
Once again, Finkel dug to the bottom of the barrel.The real #$%$ suckers. he took the easy way out.
I also noticed that MAXIM charged RGRX an 8% fee...8% is a lot. but then, true to form? RGRX ut MAXIM in for an ALSO over 250,00 FREE warrants.
RGRX is dealing, again, with teh low lifes of investment world. Sad, but so typical.
Hey, I ain't thrilled they used the CAE again....when AGN and Shire refused to (if Ora was working with them). But nothing we can do. but we always KNEW that even IF the trial went swimmingly well, since it was a PHASE 2b/3.another trial woudl have to be done REGARDLESS! So we are just doing another trial, as planned.....the bad issue was that the data looked worse because of CAE, which lowered our share price and forced more dilution from penny sales and warrants.. It coudl have been worse, if they did MORE than $1.75 million.
the gist of my post on EYE NK is that we KNOW G Tree has a summer meeting w/ FDA....when? At that meeting RGRX/GTree must tell FDA that they cannot get a mere 46 pts for Orphan EYE NK if they face risk of damaging their eyes because they get on a do nothing placebo. I'm not sure I woudl take that 50% chance if I had bad EYE NK issues.....I woudl take whatever to stabilize it and wait for some other sucker to do the placebo in trial.
You are missing something. Revenues coudl come far sooner that 2018, IF.....the Phase 3 Orphan Status EYE NK trial gets finished. It is a marketing approval trial. It only has 46 patients needed. With orphan Status, we get an expedited FDA approval review of 6 months....thgere is no good current therapy. the ISSUE is that they have hard time getting patients, because teh Eye NK disease is serious to their vision already....so pts don't want to sign on with a 50% chance of getting a "do nothing" placebo. G Tree needs to ask....no, beg....the FDA to make that trial an open label one.....TB 4 pts only. You will still find out if it works, by simply looking at the eye healing (if any), where no other therapy is that good. you don't need a placebo! if the FDA would loosen that restriction, I bet they coudl sign up 46 patients within a couple months......be DONE in a few months after....and final analysis of only 46 pts goes very quickly. If that trial ever worked, RGRX will skyrocket.....the revenues woudl be on small side, but more importantly it shows TB 4 WORKS....which will increase chances in the final GOOD DESIGNED dry eye final phase 3. if the FDA would loosen the placebo demands, EYE NK coudl be finished and reported within 8 months or so. No need to wait till 2018.
No big deal that there is size offered at .60..CDEL isn't a long seller.they would offer 60,000 at .60 cents to go short, if anyone wanted it.....and soon they'd buy it back cheaper.
our bad dilution news is out. the only possible news I see now is what will happen at the "this summer" FDA meeting. WHEN is it? Will the FDA approve Phase 3 final trial design at that meeting? What was OSDI ? Did ANYTHING happen with the glaucoma measures? Will G Tree ask to amend the EYE NK phase 3 to make it an open label trial.since it is pretty apparent they cannot get ill patients to sign up and have 50% of a "do nothing" placebo. if ALL patients were getting active TB 4....I bet they woudl get 46 patients within a month or two.
1. Be glad it was only $1.75 million and not double that....20 million possible sharess, for $3.5 million, massive dilution, instead of what we got in manageable dilution..
2. we still own all heart and neuro.
3. we still own all europe eye rights.
Now we are in for all or none.We have enough money to pay Finkel and his rent for about a year or more. By that time the last, well done phase 3 will be finished. It is now in G Tree and FDA hands, which is why (WHEN) this "summer FDA meeting" is crucial. we need the same EASY phs 3 design that Shire and AGN got....we need to ask FDA to adjust the EYE NK trial to OPEN LABEL....n o placebo. there is no therapy for EYE NK, so why does a placebo make any sense? then we NEED RGRX to disclose the OSDI measures from trial and we need to see what, if any, effect was seen on glaucoma measures. RGRX is still not disclosing TONS to us.
I'm afraid not, flgeez..there's no way that McNay woudl be able to place that 5 million shares into an Exxex Investment fund...because there is a serious conflict of interest.McNay is a Board member and thus has (in theory) all kinds if inside information. he can't use that knowledge to then invst in RGRX shares in a fund his firm runs, and Esses is getting a $$$ feee to manage/invest it, with McNay knowing the 'inside skinny" on RGRX.
I knew in my heart Finkel would take the "easy" way out for money. I predicted a low 30 cents stock sale,,.with equal massive free warrants. the only positive I see is that Finkel held it to only $1.75 million. I was guessing he woulfd have gone for more. It doesn't matter to him. HE is getting paid and he just got 125,000 free options. he get's bi weekly cash... and he isn't diluted as we are.
You miss the point B7.....for all intents this is a PIPE deal.....sold big % discounted stock.....gave away warrants. the question is NOt the 45 cent bidder. the question is WHAT will the buyer of the 5 million shares do when it is REGISTERED (within 30 days). Will they sell and try to make a profit from 34 cents to mid 40 cents? that won't last long...no way can they sell 5 million like that.
We can just pray that the "institution" is playing for a TB 4 home run....all or none like us. which means they HOLD and not sell like every other PIPE RGRX did.
Randall Kirk woudl be ideal buyer for us. he has "gravitas". There are a lot of people and institutions that piggyback into whatever he buys. Kirk long ago owned a big stake in SCLN, which is Thymosin. Krik is probably aware who Goldstein is, inventor of Thymosins.. But somehow, I don't think this one institutional buyer is Kirk or his firm third Security....because I don't know if Kirk has had any prior relationship with Maxim Securities.
What worries me is this.Maxim (MAXM) is big on PIPE deals. I want to know WHEN the original 5 million shares bought 34 cents is REGISTERED and able to be traded.i.e. SOLD. A common play for PIPE deals is to buy stock at a big discount.trade out of it for a small profit.and then RIDE the millions of free warrants as a huge free lottery ticket. we will only know if the buyer is just another PIPE trader, when we know when the shares are REGISTERED at SEC to freely trade. if we see sell volume on that registration, we know they want to trade out of it and ride free warrants. if we don;t see volume selling, the institution is playing for a TB 4 home run on next trial...and bought in very cheap and very big.potentially 10 million shares for a mere $1.75 million.
It isn't 150 million shares diluted now. We have about 100 million out.another 20 million in options, warrants and converts. Add in this 5 million shares and 5 million warrants.that puts us at 130 million or so fully diluted shares.
This also means that RGRX is going fpr teh whole candy bar.they aren't in discussion with any big pharma for a deal...whether there were discussion or not, we don't know.
I gave the best odds that this would happen. But hoped it wouldn't. Priced in low 30 cents, with warrants.jjst as I guessed.Finkel took the easy way out.
I am very pleased that we did not drop by 15 cents! The KEY now here is WHEN is the FDA meeting to review teh trial.and hopefully at same sit down w/ FDA approve a Phase 3 design w/o CAE. And I ALSO hope that G Tree can ask FDA to relax Eye NK trial design. Make it OPEN LABEL.it is quite clear that teh EYE NK trial cannot find placebo patients. ther eIS NO THERAPY for Eye NK, so why bother with ANY placebo! ALSO, WHAt were the OSDI numbers and WHAt was the result in GLAUCOMA measures!
What I've said all along.I was scared of a penny financing well below the market with a LOT of warrants attached. And there it is, as I worried....cheap penny dilution. On a positive note, it could have been double the 1.75 million. RGRX is well funded now for Finkel salary for about 15 months or more. With 10 million more shares, diluted. It is also good news that ONE institution bought the whole piece. It basically is a PIPE deal.had it gone (sold) to many places via Maxim.the PIPE traders just sell and hprt afterwards. If one place, they may hold on and npt sell. we don't know. It is also good that no more rights were sold for cheap.
If my quotes are right.we are at 49 cents.so it isn't a disaster.
G Tree steadied outy and was up 400 points..initially opened up down a bit. Downdraft was pure Brexit selling.
I wish Finkel Tinkel woudl tell us more. we KNOW RGRX is out of money in about 90 days. I give him kudos for not filing for a huge diluting penny stock & warrant puke down.yet. So we then look to a non diluting funding. but what does a non diluting participant WANT....INFORMATION....DETAILS.... TIMELINES and RESULTS! All of which Finkelstein hides from us. If I was an outside investor/partner, scoping out RGRX & TB 4.I would not move until I knew what the BUREAUCRATS would do to me.namely the FDA. I thunk there may be some kind of deal in the works, but THEy need to see exactky what the FDA will allow in the final trial. So WHEN is this summer FDA meeting/ TELL US FINKEL! What was the effects of OSDI in teh trial, Finel, TELL US. What effects were seen in the Glucoma intraocular pressure measures...over 300 HUMAN patients were tested, which makes the Phase 2 dry eye trial, basically a parallel preliminary Phase 2 GLAUCOMA trial!.
If RGRX wasn't managed by losers....EBIO should partner out the TB 4 heart and neuro rights.because that woudl send EBIO stock to $10.....right now, the WHOLE value of heart and neuro of TB 4 isn't even worth whatever I have in my wallet right now for cash.
Conventional antibiotics might fail in the treatment of biofilm-associated infections causing infection recurrence and chronicity. The search for antimicrobial peptides has been performed with the aim to discover novel anti-infective agents active on pathogens in both planktonic and biofilm associated forms. The fragment 9-19 of human thymosin β4 was studied through 1 μs MD simulation. Two main conformations of the peptide were detected, both constituted by a central hydrophobic core and by the presence of peripheral charged residues suggesting a possible mechanism of interaction with two models of biological membranes, related to eukaryotic or bacterial membrane respectively. In addition, the peptide was chemically synthesized and its antimicrobial activity was tested in vitro against planktonic and biofilm form of a group of reference strains of Staphylococcus spp. and one P. aeruginosa strain. The human thymosin β4 fragment EIEKFDKSKLK showed antibacterial activity against staphylococcal strains and Pseudomonas aeruginosa ATCC 15442 at concentrations from 12.5 to 6.2 mg/ml and inhibited biofilm formation at sub-inhibitory concentrations (3.1-0.75 mg/ml). The activity of the fragment in inhibiting biofilm formation, could be due to the conformations highlighted by the MD simulations, suggesting its interaction with the bacterial membrane. Human thymosin β4 fragment can be considered a promising lead compound to develop novel synthetic or recombinant derivatives with improved pharmaceutical potential.
It appears the FDA will vote on, or by, July 22. I always thought the FDA woudl approve first pass.but I wonder if these side effects things may give hesitation.or that the two phase 3's they did each showed differing results.but spun together, it makes a positive "patchwork". if the FDA ever does reject Liftegrast, TB 4 and RGRX woudl instantly become more valuable. After all.BOTh Liftegrast.....Restasis and even AGN's new drug TAV.ALL FLOPPED TRIALS BEFOREHAND....and too several to pass. On things stands out clearly in Restasis and Liftegrast.they have side effects and they are a LONG TIME DOSING. TB 4 has no side effects and acts in 4 weeks or so. CAN YOU IMAGINE WHAT a stock & mgmt like at EBIO would do with TB 4? As Cramer used to say, 'TO THE MOON, ALICE".
"February 4, 2016 – Shire plc announced today that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for lifitegrast for the treatment of signs and symptoms of dry eye disease in adults. Shire resubmitted the NDA in response to the complete response letter (CRL) received from the FDA on October 16, 2015 that requested an additional clinical study and more information related to product quality. The FDA determined that the submission is a complete response and has assigned a 6-month review period for the NDA and a Prescription Drug User Fee Act (PDUFA) goal date of July 22, 2016."
I won't "down thumb' this one bo.but I have posted before of flgeez......respect your elders.....my 92 year old mother is in a place that is not far from him...and he was looking into her facility for himself. I'm just damn proud that he is so adept on a computer, really. I've been down to the FL place and a lot of that generation there......is the WW2 generation...has no clue of computers, and don'rt care to ever learn.
MAuro Bove means nothing. He no longer represents any interests for Sigma TAu (it was sold) or the Cavazza family....because he quit or retirrd a few years ago from ST . he is just along for the ride now, and gets free stock options to do so. His votes on the RGRX BOD are nothing more than a rubber stamp for ehatever Finkle or Goldie want.
HEY, are YOU stealing MY thunder? You sure sound like it.where is OSDI.where are glaucoma measures.. We don't need hardly any great reduction in intracoulcar pressure, for a major hit..... The trial was't for that. And ALSO, they measured pressure on DAy 1 and Day 29.which was CAE fail torture chamber day. Day 28 would have been better.
But just another day at the races with the dope that runs RGRX. Look at ANY PRESS RELEASE AND RELATED STOCK MARKET REACTION FOR "EBIO".
While we are at the FDA trial review...."this summer"....they have to ask teh FDA to amend the Eye NK Phase 3. for ORPHAN trials they shoudl NOT force placebo patients. That is what KILLED our EB trial....after SIX years we gave up sign up. NO parent would offer up a child as a gunea pig sufferer on teh chance they get placebo, which they KNOW will NOt help. only hurt. But had FDA allowed a TB 4 trial only, HUNDREDS of EB parents woudl sign up....within 6 months. Same goes for Eye NK. The NK patients are already in BAD shape.....why would they further risk their eyesight to take a placebo which does NOTHING and delays any therapy for teh problem? NO ONE! But if FDA dropped placebo demand, Eye NK would sign up in a handful of months. They all want the drug, not placebo risk.
NVS coudl have interest in the whole cow, not neccesarily in G tree. RGRX is broke. RGR Xstill controls between 25% and 40% of USA rights, same Canada. RGRX owns all europe, So. America, Mexico, Africa....etc....RGRX owns all heart and neuro. These have in trerest to NVS. I'd take an NVS buyout of RGRX in a second.and doesn't have to be huge price.key is if they offer a contingent value right (CVR) for royalty on ANY TB 4 revenue they may get (if ever).. A CVR trades just like a stock. We owners still have a play. NVS is talking of selling their $15 billion stock ownership in Roche soon. NVS will be swimming in money.and their eye divison is in need of drugs, badly.
G Tree said that they will be having a meeting with the FDA to review teh trial, sometime 'this summer"....that ws teh quote.this summer. I assume it will be to review what we had great success, and some muddy....but I bet the KEY discussion of the meeting will be to discusss what parameters the FDA will allow, or not allow, for a final large phase 3. Considering that the two dry eye drugs in phase 3 by Shire and Allergen....both have much easier endpoints and do NOT have the CAE torture chamber.then I don't see hwo the FDA can hold TB 4 to a harder trial standard. It shoudl be as easy as teh others.
The other KEY here is this.maybe Novartis or some other pharma is indeed interested tb4. But if I was NVS, I woudl not be anxious to do a deal, UNTIL I see exactly what the FDA says at teh meeting and WHAT TRIAL designs will they allow. If the FDA allows designs similar to AGN and Shire.....then that is a green light to go for TB 4, and odds are good. At that point, someone liek NVS can make a play. but think about it.why woudl NVS spend big money until they have in hand, what the FDA says and what the final trial is that they will agree on endpoints in. This coudl also explain why RGRX has not filed a stock sale, YET. Someone like NVS coudl be in wings, BUT they need FDA input before the do anything. SO WHEN IS THE MEETING?