It probably will be an issue with the partner search. RGRX hasn't been able to secure a specific patent for TB 4 in eyes. They filed one and fought, but could not get thru the USPO. But all not lost……..RGRX does have a broad wound patent. In that patent filing RGRX shows example of corneal healing. Which coudl stretch to dry eye. If your eye has no tears, and you blink so often, you end up with scratches and irritation on the surface of eye. TB 4 helps that supposedly…your eye is wounded? So in a way, the scratch is a wound or irritation, as a resulty of the dry eye - no tears. So maybe RGRX feels okay with a broad based patent? The last stab by RGRX was an eye patent filed with Dr. Sosne. RGRX finally gave up and abandoned that one in 2012. But RGRX started that process around 2001. Amazing.
But some good news. I forgot that eye NK is an Orphan Designation. That means, no matter what, if ever approved, RGRX (or partner) get's 7 years exclusivity…regardles of anything or any patent..even if you have no patent on it…you get the 7 years. And you get tax credits as well. So if a big pharma wants to partner TB 4 for eye NK and dry eye, they know if it works they will make it all back, and more off NK….but they should move to getting a specific eye patent ASAP. Hopefully RGRX issued patent covering all "wounds" may keep others at bay.
THere are just too many clues, that I don't see as coincidences. Bersky had about $80 of long term debt. Interest on debt is a tax deduction. So why did Bresky pay a $3 million PENALTY to the lenders, to retire that $80 million debt now" It was due in 2021. Furthermore? The 10 yr treasury hit 2.00% a week ago. Why on earth did Bresky PAY $3 million to retire HIGH coupon debt, whenwshat he shoudl do, and tons of companies are now, is SELL debt immediately, NOT BUY DEBT!. Lock in these all time low yields for as long out as you can. CHEAP money! Bresky is not dumb, but he did the exact opposite financial of logic. why? Simple. If a suitor is so debted up on their balance sheet, it is better if they wanted SEB to have SEB DEBT FREE. Buyer assumes no more debt.
Also weird why Bresky soild 50% of his Daily's Meats. Sure he made a profit, but why sell a growing good niche product? Well, here's a clue. JBS got rid of ALl their "processed" meat stuff when they bought Swift. evidently, JBS does not want anything to do with bacon, sausages, hams etc……but yet they big on Hillshire? But they got out of their own? Odd. And very odd that Bresky just followed what JBS did with Swift…cut back on processed pork (bacon, ham, sausage).
This SEC filing is odd. Why was a lawyer looking so closely at SEB's filings now? It is not year end. And even if it was year end, what made the lawyer dig so hard that he went back years. he found a slight error in a 2009 filing, and corrected it a couple days ago. It's fine they corrected a small boo bo. I don't care. What I want to know is WHY a lawyer for SEB is so deep into SEB filings, right now in October?? What is his purpose?
I'm not buying up here. That crack down to 2500 was scary. But I still have my bet on. I think PPC desires SEB. And the manueuvers Bresky is doing (as I tell above) are good clues.
Anyone notice the two SEC filings by Bresky a few days ago? No real big deal, but strange. he was updating a 13-D……total family holdings. One filing was to update a couple k shares that was in two kids trusts. It seems that was incorrectly showed before. but the odd thing the other filing dates back to 2009, updated. So what got me is this….why did they come, out of the blue…….to update a filing over a couple kids, from a 2009 one? No lawyer caught that for the past 5 years. probably a simple oversight and SEC would understand. but why is it NOW…that they do it? 5 years after? What it signals to me is that for some reason, Bresky has a team of lawyers going over a lot of things on SEB books and filings.…and it is not related to any year end stuff.…it's only October….and for some reason everything has to be perfect for SEC?. Have any guesses why? I do. i'm staying long for my gamble. but not buying anymore up here. Comes down again I will.
I forgot one problem. A big pharma partner will want to see teh patent for TB 4 in eye therapy. It's not as likely they'd do a deal and spend money, if RGRX does not own the IP for TB 4 eyes. RGRX does have other broader TB 4 patents granted…like wound repair…..and if TB 4 heals the cornea as part of dry eye, maybe that quakifies as a woiund and it s covered.
Maybe someone else can go thru the USPO………I don't see that any of teh eye filings have made it thru USPO. The USPO has been a real problem for RGRX.
Trying to think of logical partners. It woudl help if we knew which pharmas are also clients of Ora………Ora is key. But a few names seem logical and two are in a mess right now.
Allergan owns RESTASIS, so AGN is the most logical choice. But unfortunately they are in a fight for survival from an unwanted takeover offer from Valeant (VRX). But VRX is logical since they bought out Bausch & Lomb…a big eye care firm. So VRX might have interest. But VRX is in tehe takeover fight for AGN.
Johnson and Johnson has an eye division…….
But a very logical choice would also be Novartis (NVS) They bought out Alcon, which is one of the worlds largest eye care companies…and Alcon is now NVS's second largest division. I'd like to know if Alcon/Novartis ever used Ora Inc for trials…..be a great match and NVS has all the money in the world…….and they woudl love to takeover dry eye market from Allergan and their RESTASIS.
No, RGRX did not get the phase 3 trial approval "in September". read heh release, it says:
RGRX…."today announced that it met with the FDA in September and as a result of the meeting may begin Phase 3 to evaluate RGN-259 preservative-free eye drops for the treatment of patients with…."
RGRX only HAD a meeting in september. It would be unheard of for RGRX to have a meeting with the FDA.perhaps a couple hours or so……and right then and there the FDA approves it as a phasse 3. The better scenario is that RGRX met with the FDA (as stated) and it took the FDA until mid Octopber , after they reviewed and studied RGRX request and supporting material..and perhaps even followup calls/questions…that the FDA went ahead and said 'Okay for a Phase 3".
I very much doubt any partner is 'committed" yet. RGRX had nothing to sell..until yesterdays new from FDA. RGRX can now sell a mere 90 patient trial phase 3. That is huge, imo. Now we need Ora to get the word out to their clients.
there won't be a partner here for a while. RGRX had nothing to sell, until yesterday. A crucial thing was the FDA allowing the tiny phase 3, only 90 pts. That is a massiive cost saver to a big pharma….a mere 90 pts, direct to phase 3 and no phase 2 delays. So now RGRX has something to offer. The next step is for a partner to view all previous TB 4 data. Then a partner surely will contact Ora Inc for their input. It is in Ora's interest to see a partner deal too…because the big pharma partner woudl surely use Ora to do the small Phase 3 (for a few million $)……the PR yesterday did NOT state that RGRX had the money to pay for Ora to do the trial.
The next logical step would be for an interested big pharma to attend the meeting later this week. In one place, they can talk behind the scenes to a few dozen Thymosin researchers and get great imput all in one place. But I don't know if this FDA news yesterday, will give enough advance notice for Ora to contact a big pharma clients of theirs telling they shoudl attend, if interested in partnering TB 4 for eyes.
So we wait. The BEST news is that Ora Inc is involved now to some degree. if there is a partner deal, it will come via Ora's contacts, not Finkels.
Therfe's plenty that can still be made with a Orphan dug. Big pharma will like the incentives. There isn't any regulation on prices, just because it is an orphan drug. But, eye NK is a pretty small population. So they could chatge more. But if it ever get's approved for such serious disease as eye NK, it is a no brainer it is approved for dry eye. but Dry Eye is a widespread problem…..so the dry eye folks couldn't pay what eye NK does, but the TB 4 is the same.
My hunch is they woudl price eye NK TB 4 fairly..the real prize is DRY EYE. Maybe someone here can find out what Allergan charges for RESTASIS. That is a $1 billion drug for Allergan. Any $1 billion drug is hailed as a blockbuster. If TB 4 ever works in dry eye, it could be a blockbuster…..because TB 4 actions aid healing in cornea. RESTASIS does not. RESTASIS only aids in increasing tears, it does no surface healing. Also, RESTASIS has not good side effects. Many will not use it. TB 4 is side effect free. So yeah, TB 4 coudl be priced exactly what RESTASIS is and still reach $1 billion sale. But it ALL DEPENDS.will it pass trials. we don't know yet.
This should be fun. Out of the blue decent news. 375,000 shares trade. So let's have a contest. How much of that was shorted? I really don't know………it could be small, it could be large….but I'm sure we had some long sellers too.taking advantage of the bounce. Maybe being tax efficient with losers. But I'll stick my neck out and say 150,000 shorted today.
wow! Go to Ora Inc website. In lower left, click on 'new and publication"……yget a list of articles, and this one by one of Ora's founders and a dr. at Harvard Medical School..dr. Abelson. 'Healing teh wounded Cornes". It goes on to talk of eye NK. BUT, read what he says about TB 4 as a potential! This is what pharma partners need to read! And Ora tells them. we all missed this piece.
"Like NGF, thymosin β4 is an endogenous constituent of serum, but Tβ4 is normally found in much higher concentrations. Thymosin β4 is a major constituent protein of platelets, macrophages and polymorphonuclear cells where it acts as a G-actin binding molecule and regulator of actin polymerization.17 These cell types function in trauma response, and Tβ4 gene expression is among the earliest to be upregulated during the process of wound repair. In addition to regulating actin polymerization, Tβ4 is released into the extracellular environment of wounds where it promotes tissue remodeling and repair in dermal, ocular, cardiac and central nervous system animal models.
Several studies have established the potential for Tβ4 as a treatment for corneal wounds. It was effective in treatment of corneal defects in patients with GVHD, and was also efficacious in a study of severe dry-eye patients. (Sosne G, IOVS 2013; 54:ARVO E-Abstract 6033) In a 2010 study of patients with stage-2 or -3 NK, Tβ4 treatment resulted in complete healing of persistent corneal defects in six of six patients studied.18 It's interesting that a protein that functions as a major regulator of the cytoskeletal protein actin also affects tissue remodeling; whether the two functions are linked remains to be established. Another potential treatment on the horizon for epithelial wound healing that has a clear connection to cytoskeletal function is a peptide mimetic of connexin43. This polypeptide, like Tβ4, has shown promise in treatment of both skin and corneal wound healing."
Maybe I read between the lines? The RGRX press release stated that Ora Inc is consulting with RGRX on a range of issues, regulatory and I hope design. But notice how RGRX did not say that Ora Inc was executing the Phase 3? That was left wide open. I am sure Ora would like to do the phase 3, but Ora also sees that RGRX is all but broke and RGRX will need about two years of trial money to pay Ora….at LEAST a good handful of millions. And If I was Ora, their contract would have a healthy bit $ upfront. Ora cannot bank on RGRX selling tens of millions of shares at 12 cents again. But with Ora consulting for RGRX, that leaves the door wide open for Ora to talk to big pharmas as a partnering option…because technically, Ora is has NOT been hired yet to do the phase 3…they just consult on regulatory. So if RGRX can't pay Ora to do phase 3, (it seems) it woudl behoove Ora, with RGRX's blessing.to start partnering negotiations with large Ora client eye pharmas…and as part of the deal for Ora, if they find a partner, I'd guess a big $$$ pharma, then Ora get's paid back by the big pharma partner signing Ora to do the phase 3. Everyone wins.
I think it odd that RGRX was not clear on that. i am SURE that the FDA would much prefer Ora does the phase 3….but no money and no partner. I think good odds now that Ora will find a partner and they will then use Ora to do the phase 3.
If we get a big pharma partner for eyes, it will likely come through Ora Inc and their long ist of big pharma clients. From Ora's website, read these two pargraphs of service Ora offers! first:
"The Ora team can provide Venture Capital firms and investors with both consulting and capital services. These include due diligence and M&A intelligence, licensing and asset evaluation intelligence, as well as market intelligence designed to track a wide array of ophthalmic therapeutic areas.
BUT! Here is the key paragraph that will apply to RGRX and TB 4 chances for a deal!
"We are also able to bring together our network of pharma companies and investment firms to facilitate collaborative partnering arrangements. Our unique position within the ophthalmic space allows us to serve as a bridge between emerging companies, larger marketing partners, and investors."
Ora Inc will offer to "Facilitate collaborative partnering arrangements….." Tghis is what RGRX needs and Finkelstein is unable to do. Now with FDA approved Phase 3, maybe Ora Inc can do what Finkel can't????? Let us pray!
Our odds of FINALLY getting a big pharma partner have greatly increased. eye NK is a 90 patient phase 3 9that is TINY to a big pharma) It is an orphan drug which has great attributes to a pharma. With 90 pts the cost is less, the time to do is less. PLUS! TB 4 is 100% safe and side effect free (this is important to a pharma. Restasis has not food side effects and it is approved). RGRX does not have the money to do 2 phase 3's, even small ones, if it takes a year or two. But a year of two and a handful of $$ million, to a big pharma is NOTHING. It is a crumb to their total R&D budget. Also? the fact that Ora Inc is inviolved to a degree, is a bonus. because Ora Inc does all the trials for the biggest pharmas in the eye area. So a pharma can talk to Ora about TB 4 as opposed to Finkel. Ora can tell the goods and bads, honestly. In the end, for a handful of millions, I think we may just get a pharma now.if Ora helps us.
That was one bit of news I was hoping for. Go direct to Phase 3 Eye NK. The other good newsis that Ora Inc is involved…..but I wasn't sure in the wording if Ora Inc was doing the trial? or are they just consulting on it?
The other good news is that the FDA talked of trial(s) with 90 patients. That is far less than usual phase 3, probably because eye NK is an orphan designation. The trial can be done quicker and cheaper now. And since it is a phase 3, with 90 patients, the cost is a handful of million..which increases the chances a BIG pharma will jump on board. for a few million outlay they get a phase 3 and don't have to wait and mess with phase 2. Ora Inc involved helps to. PRAY for a partner!
That is our biggest day dream….that somone with the respected abilities of Henry ford says they are willing to pay for and design and do a TB 4 trial in a neuro area. I think the market would respond kindly, because Henry ford knows what they are doing. HF has been working with TB 4 in neuros and even heart areas, for over 5 years..with a handful of their researchers. But I wonder what good is all that time and money, if HF has no intent on following up in a human trial to see if their years of pre clinical evidence stands up? we don't have any idea if they will.
The other BIG thing is that the other keynote speaker is the head of ALL the EMEA..drug approval agency for ALL Europe. He has personally worked with Thymosins before he was apponted to that post. The fact that the head of the EMEA is taking time to speak at the Thymosin boondoggle……hopefully wakes up some other pharma executives. There is a friend of Thymosins at the EMEA….and his agency approves drugs.
I just checked the schedule. It is doubtful that there will be much on this work of TB 4 in heart transplant. They do not have a speaking presentation…and even if it is in a "poster Session"….there obvioulsy are not many poster abstracts coming in….because the "poster" session is on friday 24th , and only between 5 and 6 pm….a lousy 60 minutes……so that tells you the posters are few.
You make a huge mistake assuming anything with Finkelstein. You can't assume this work will be presented at bondoggle conference, nor can you assume it will get any press. Press and investors don't care about RGRX anymore. They gave up, IMO……because for over 20 years they have been putting out same, old same old…and nothing ever happens…….except they still get paid and we have to sell a couple tens of million shares almost at 12 cents. That's why no one cares. Whatever news (IF) they have, they batter hit it hard and big….. but somehow, i'm not holding my breath. let's hope this time i'm wrong.
New abstract. And a new area foir TB 4. Using it as a boost during/after heart transplant surgery. This a pre clinical one, done with 10 pigs. Better data than with tiny mice. Go to Pub Med to read full abstract and methods.
"Adeno-associated viral vector 2.9 thymosin ß4 application attenuates rejection after heart transplantation: results of a preclinical study in the pig.
Graft survival is the most important factor for morbidity and mortality in cardiac transplantation. Improved immunosuppression significantly reduced early graft rejection. However, acute rejection may predispose to chronic rejection. Targeting both phases of the recipient's immune-reactivity by means of long-acting recombinant adeno-associated viral vectors (AAVs) encoding anti-inflammatory and cardioprotective factors appears to be a promising therapeutic approach. We investigate thymosin ß4 (Tß4) possessing anti-inflammatory and prosurvival abilities, as a means for pretransplant gene therapy.
The AAV2.9 transduction induced robust overexpression of the transgene. In addition, Tß4 ameliorated inflammation, necrosis, vascular reaction (acute rejection) and in parallel improved capillary density. In addition, graft survival was significantly prolonged (10±3 days AAV2.9.LacZ vs. 31±4 days AAV2.9.Tß4). In the mini pig model, regional myocardial function of the grafts was improved by Tß4 transduction compared to LacZ (9.1%±0.9% subendocardial segment shortening in AAV2.9.LacZ vs.
It isn't just PPC..Sanderson Farms (SAFM) is getting killed to…..it is down $7.75….but that is a $79 stock……PPC is now down $4.57….but that is now a $27 stock….I think shorts in PPC are over 7 million shares now…maybe they know something we don't…but why the tandem smack down in SAFM at same time as PPC…..both held up VERY well when the Down collapsed 800….? So why collapse today???
Get's odder…..PPC is now down $3.35…….but also Sanderson Farms (SAFM) is down over $6.00 to……….no news I can see on either to account for such down moves. Nor can I see one for SEB going up $300 in three days.
One thing occurs to me…. Bond yields were around 2.45% a cew weeks ago (for the 10 year)…yesterday during the big panic selling, the ten year hit 2.00%…..which means costs to borrow for everyone also went way down. I think that yesterday, a 2.00% ten year, was close to, or was….a generational low in interest rates. If I was a compny , now is the time to load up and borrow.