These numbers you thow on values, too low. When Shire anounced their phs 3 succcess of Liftegrast late last fall, Shire stock added $3 BILLION in market cap,\. Shires CEO said that the dry eye market is understated. It is'nt the $1.5 billion that Restasis does. It is closer to $2.5 billion worldwide, because Restasis is so not tolerated by many,it does not reach penetration.... and all restasis does is create more tears in the eye. Restasis is NOt approved for Dry eye. It is only approved for "adding tears". Liftegrast seems to adress some corneal abrasion issues as well as increased tears. But it is a LONG dose.over 6 months, and it is muddied data and it has some minor side effects as well.
If TB 4 HEALS the cornea, does it in about 30 days, does it with simple 4x a day eye drops, and does it with no side effects......then it will blow away both Restasis and Liftegrast. The market in USa could almost DOUBLE, because 25 million people suffer "symptoms" but cannot take Restatis! if the data on our trial is good enough, Shire and Allergan WILL notice and if they want to own the dry eye space.......and TB 4 bests BOTH their drugs (what they hope), they have to have TB 4.. I think G Tree will sell it, for the right price and G Tree will then lock up TB 4 for hear and neuro. I think you see that within a month.
to you guys that have been around a decade...friends and adversaries....we're still same side basically..just different ways of thinking. I've been very stressed, not drunk at all.... as bo posits. It is the way I talk.....15 years I was in exchange trading pits, yelling & screaming and having a blastt..can't get that out of me, ever, so don't hope.
Last Thursady my 25 year old son has a brain tumor removed. Friday we got the usual muddy from RGRX. We were hoping for a benig reading, but just now got back that it is indeed brain cancer. Much of the tumor is out, but tiny bit stayed, too hard & risky to reach. It is NOT a glioblastoma, which is a less than one year survival. It is one of two others, both of which respind to radiation.but both can spread fast. the prognosis is good.....but you still play odds for 2, 5 or 10 years..who knows. And my double knee replacemnt of late Nov isn't working as well as I hoped. So overall, you might not blame me for being "pointed".
Take care all your families, they're great.
Funny, I tell this board before other friends......don't want that attention yet from them, nor ya'll.
$1.50 seems low on good data. I'd hope closer to $3. At $1.50 that is a market cap abouy $175 million. Dry Eye will expand to $2.5 billion annual market. It is now only $1.5 becauise so many cannot or refuse Restates.. if TB 4 works, 30 day dose and NO side effects.you get to $2.5 billion quickly.
second, if trial works....there are direct off label uses to add in......LASIK Surgery. About 700,000 a year are done. Two very common post op issues are dry eye and healing after incision. If TB is prescribed after LASIK. That is 700,000 a year.
Third, We don't know what the Glaucoma pressure test was for in this trial. Glaucoma is a leading cause of blindness...probably a $2.5 billion market. if TB 4 trial works, is 100% safe, and shows it is doing something on ocular pressure measure..that data is worth BIG to a pharma doing glaucoma wok.
Fourth, if TB 4 trial works dry eye, it validates that TB 4 does work, with medical result. This opens the door to heart and neuro possibilities. Those two areas have exactly ZERO value in RGRX now. If dry eye trial is a win, a value will be given to those to long shots.
I think a lot depends on the P VALUE seen. P 0.05 is a win, but a big pharma may wonder can it replicate for confirmatory trial next?. But if we ever got something like a P 0.02 or a P 0.01.....that will be a remarkable statistic and big pharma WILL notice. And they wouldn't let RGRX stay at $175 million too long after. Allergann is soon receiving $40 BILLION from selling a divison to Teva. $175 million is a crumb. but that crumb may save dry eye market for AGN. Restasis is in trouble later 2016.
wow. wait till you read this. from our 10-K. It explains two areas of TB 4..in INFLAMMATIOn and now more importantly, APOPTOSIS in eye cells. read my previous where glaucoma may be caused by INFLAMMATIOn and APOPTOSIS!
"Reduction of Inflammation and scar tissue formation. Uncontrolled inflammation is the underlying basis of many pathologies and injuries. Independent research has shown that Tß4 is a potent anti-inflammatory agent in skin cells and in corneal epithelial cells in the eye. Tß4 has also been shown to decrease the levels of inflammatory mediators and to significantly reduce the influx of inflammatory cells in the reperfused heart of animals......................
Anti-Apoptosis. TB4 has been shown to prevent apoptosis, or programmed cell death, in two animal models and in two tissue types. In the rodent model, corneal apoptosis, or loss of corneal epithelial cells leading to corneal epithelial thinning, was prevented through topical administration of TB4 eye drops. In the heart muscle of ischemic animal models, such as in mice and pigs, cell death was prevented by either local or systemic administration of TB4. It acts by reducing oxidative enzymes."
OMG..there is a condition of childhood and pediatric GLAUCOMA. Know what that means? It means FAST TRACK and ORPHAN STATUS!. All RGRX needs is to see TB 4 doing good inside intraocular pressure in this trial. TB4 is 100% safe and side effect free. The FDA knows all about it in eyes. They granted Orphan Status phase 3 eye NK, a regular phase 2 dry eye and a phse 2b/3. With THREE trials of data seen, shoudl there be intraocular pressure effect positive.....the FASTEST way for RGRX and G Tree to get Glaucoma tested is ORPHAN STATUS and you can make that EVEN FASTER if you do PEDIATRICS and CHILDREN! Plus! Go look! IF YOU DO PEDIATRIC and CHILDRENS ORPHAN DISEASES, you get super fast, super fast FDA REVIEW because of that. but to SPUR people to do orphan pediatric stuff, teh FDA started a NEW program where if you GET a pediatric ORPHAN drug up for FDA approval FAST TRACK, the filing company can SELL THAT FAST TRACK APPROVAL SPED UP TIMELINE to another BIG PHARMA so they can speed up a MAJOR drug approval. Do a GOOGLE on this! These Pediatric slots" have sold FOR OVER $200,000,000.00!!! RGRX and G Tre are SET FOR LIFE to pay for ALL trials, if they ever tried a PEDIATRIC ORPHAN trial in a few dozen children. If TB 4 ever worked and they apply FDA, that fast track aproval slot coudl be worth $250 MILLION! Google it yourselves! FINKEL! LOOK AT PEDIATRIC GLAUCOMA... if the trial shows efficacy in that tertiary endpoint test!
That is just plain silly. Basically what you are stating is that Ora is divulging ALL the trial data to RGRX and G Gtree ahead of time, and G Tre and RGRX then go out and tell that to all kinds of folks who then BUY Gtree and RGRX shares, causing the price to go up.all based in INSIDE information.....which the SEC can trace vety easily and put you in jail. Duhhhhhh!
SECOND! I can give a VERY logical scenario why G Tree goes DOWN before news. the VC in Korea is advising the Korean gov't, who gave an $8 million free GRANT to G Tree for the eye trial t apperas the VC advised the gov;'t to buy a convertible bond from G Tree too. That convertible bond was owned by the gov't. Thsy JUSt convertd it in to stock. It was for about 5% of G Tree stock. they bought when G Gtree was around 4,00 won. At 19,000 won, they have a 400% to 600% PROFIT. if G Tree value is about $300 million valuation, 5% is $15 million. So we ALSO know that it looks like ANOTHEr JV deal is in the works. $250k was put down. my guess is for heart & neuro. SO? what if the Korean gov't is willing to put ANOTHER $8 million in to G tree taking heart neuro, $8 million will start the ball rolling. SO! the Korean gov';tr CONVERTS the bond, and sells 1/2 the stock they get to GIVE TO THE NEXT JV.hgeart neuro, and then the gov't rides the other half. ALL THIS MEANS that G Tree may go DOWN before news if the Korean gov't is trying to raise $8 millon cash for a grant to G Gtree heart neuro JV..by SELLING stock! LOCK in a guaranteed profit no matter what trial is, then ride teh other half of stock.
I wouldn't congratulate Finkel yet. 250k is nothing and we do NOt know what other stuff he is negotiating to sell or what he woudl get. IF dry eye trial works, TB 4 worth a LOT more.
let's not forget that G Tree owns 19,000,000 shares of RGRX....so it is also in their best interest that if RGRX raises money, it does so in a least diluting manner. On any eye trial win, the heart and neuro instantly become from worth from nothing, now.....to something a lot more. RGRX has stated that heart and neuro are "Phase 2 ready". And we know that TB 4 is basically 100% safe.. Many big pharma pay a lot more $$$ for pre clinical or phase 1 drugs. HAving heart and neuro phase 2 ready is a bonus. if the eyes win, I woudl bet that G Tree will be very interested in doing a JV for heart and neuro.....and RGRX coudl get a solid handful of million $$$ upfront. Plus any dry eye trial milestones. That will tide RGRX over...G Tree sees no dilution of the 19 million shares.and G Tree investors get excited about possible heart neuro apps, and G Tree will be swimming in money on any eye trial win.
Not the usual pattern of RGRX trading. Up 5 cents on a mere 17,000 shares? Oh dear....NITE has never allowed such before. They always have offered..like......168 million shares on the offer side to "cap" RGRX Like when NITE offered 250k shares on offer last week..and almost all of that was shorted. FINRA numbers were huge. SO? B7 has talked often with FINRA. the person he talked with said the situation had ben handed over to 'FINRA MArket Regulation". So my day dream is that FINALLY somone in the regulation dept contacted NITE and just asked them what they heck they are doing. Are they making a market? or are they there to just offer huge size in RGRX and short it to keep it down.......but that is against SEC rules to POSITION trade short as such, in a MM account.
here's hoping that somone at FINRA finally contacted NITE and let them know damn well that there have been a LOT of complaints on how they handle RGRX and we are watching you. Too early in day to see if the gain holds..or if NITE will offer 250,000 shares again.
It's been a dfiferent feel. Yesterday we traded up on low volume, nis sign of NITE Games. Today we're now at 0.67......up 7 cents or so. Volume 46,000..but that still adds only to a value of just under $30,000. for $30,000 trades value, NITE and CEDL woudl have ALWAYS halted such run, by offering gillions of shares to short. But no sign of it today, and guess what? RGRX rises!
There's not much sign of the "NITE-CAP". Feels nice. Not a one-way-street that RGRX has been for so many years, under the" jack-boots" of NITE. at the throat of RGRX share pice. That is exactly what NITE did.
here's to hoping the possibility that B7's efforts to FINRA warranted that their MARKET REGULATION DEPT finally contactd NITE and CDEL.and a lot of things they were doimng just weren't "kosher". when they stop doing the "NITE-CAP' of RGRX.low and behold , we rise.
But day isn't over yet NITE and CDEL not very happy campers.
OH, this means the BOD met as well, so I'm sure it was discussed how they can raise a few million to pay rent & salary. Pretty clear that Rodman will be the banker....they stepped up w/ first report. but very good news is NO S-1 filing yet. the fact that they wait till news (we hope) for financing is a very, very good sign. I will give kudos on that.
that was weird yesterday.....very much picked between 1 and 4 pm to puke a few hundrd thousand shares. I'm not convinced it had anything to do with the MM's.. it was a long seller for the most part, and the MM's don't trade RGRX to the long side. i wondered that it looked like almost a forced margin call sell...sometimes when a really bad margin call hits, the guarntor firm takes what you have left in the account and sells..hard and fast.to raise whatever cash.
Whole thing was odd. I posted it was not likely someone who had bad "inside" trial info, because if bad and they sold like that be it short of long)....FINRA and SEC have them "nailed and jailed" in a heartbeat. FAR too easy to track in RGRX...no voulme and few MM's.
Allergan is up $7.33 pre market....and that adds up to it adds $2.9 BILLION in market cap based on thisi trial win of a device, not drug....hand held and you have to use for 180 days...to aid in making a few tears. It does NOTHING to heal a cornea, nor staining.nor OSDI. TB 4 showed it created more tears, and healed the cornea..especially in severe dery eye patients. It is a mere 30 days dose, fast acting... and no safety or side effects.. The next trial will be a success, because we got the efficacy in some groups based on day 1-28. It was only when day 29 came in with CAE torture chamber we lost some statistical. BUT TB 4 IS NOT ALONE IN THAT! Other drugs Ora did ALSO ran into issues of CAE Torture Chamber making their drug look like failure. SOLUTION? they DUMPED CAE on final trial! KNOW WHAT THEY CALLED THEIR TRIAL??? A "natural setting". TB 4 IN A NATURAL SETTING DAY 1-28 ALSO WON! Both AGN and SHIRE twisted their results to LOOK like a win! So they dumped CAE for final trial and a bigger win! RGRX's reward? A $44 million market cap.for a $2.5 billion market.
I hope Novartis is watching this fiasco. It all lays squarely back to incompetence in Finkelstein. He won't talk, and when he does it is obtuse and not explained well. Then he crawls back to the office and sews up his mouth tightly shut. ENOUGH! This is ridiculous...AGN's device for a SIX MONTH USE..to make a lousy few tears..adds $2.9 BILLION in value for AGN....we sit at $44 million. I'd vote to give Won Yang of G Tree teh CEO job at RGRX as well, fire Finkel and give Mr. Yang 10 million free options. At least those free options we might get some value creation from it. Finkel Free Options you get NOTHING...... but down.
I admit I didn't stumble on this till yesterday, but teh tertiary endpoints in teh dry eye are ....something to watch out for. One is related tio diatheses...the other is SQUARLEY target9ing Glaucoma.....and RGRX already did work on that and has a USA Patent granted.. I can find NO OTHER dry eye trial that includes as any endpooint a look at "intra ocular pressure on day 1 and day 29. We do NOt know if TB 4 will do anyting with that intraocular pressure..but I know peopel can go blind from glaucoma, and it can be up to a fe eillion market worldwide. Just add that in with teh dry eye world market of over $2 billion very soon.....you have a potential mega blockbuster. but forst we have to see what happens on teh intra ocular pressure. I will be looking at that in teh release VERY carefully, becaus eglaucoma is bigger than dry eye.:
"Almost 50% of the glaucoma patient population in the US remains untreated, which signifies a vast market for medicines to treat the disease, according to new forecasts. Glaucoma is the second leading cause of blindness in the US, and this presents makers of drugs to treat the disease with a significant opportunity to fulfill unmet medical needs, ..... As glaucoma is an adult disease, the patient pool will expand as the population ages, it notes, and forecasts that market revenues will grow......
"The third edition of “Swiss-Korean Innovation Workshop Series” was held on the topic of Ophthalmology. The goal of the Innovation Workshop Series is to bring together Swiss and Korean partners from industry and academia willing to collaborate in R&D. The role of Science & Technology Office is to bring together interested parties from the two countries to accelerate innovation and provide a neutral location for open discussion. At the third edition “Ophtalmology”, the interested parties were Novartis Korea and Korean start-up GtreeBNT.
GtreeBNT is a one of the few biotech start-ups in Korea in ophthalmic space specializing in dry eye syndrome. Currently, GtreeBNT is developing a prescription eye drops for dry eye indication. Their product is currently in Phase III clinical trials which is very advanced from a start-up’s stand point.
During the workshop, the technology background of GtreeBNT’s product was explained. GtreeBNT also shared their experience in shifting research into commercial-able medical product. Novartis team provided some helpful feedback to GtreeBNT from a global pharmaceutical’s stand point.
This meeting has helped GtreeBNT’s business decision making greatly. The collaborative discussion of the two parties not only provided an overview of the ophthalmology research and its market, but also specifically focused concerning lack of proper treatment of dry eye problems and options for the indication."
It should be a couple, or less if lucky, till we get the trial news. Seems there are two analysts out there. One with pubklished report (rodman) the other with report ready to go, but not released. Likely waiting till news. we have a ne poster from CA that is aware of such report. It is possible, even likely, that the report is from Roth (from L.A.)..as they play in the same space as Rodman.
These two reports target RGRX at 2.00 to 2.40. Of course that assumes a trial win. I think that is way too low.. Call it $2.25 on a clear trial win. That values ALL of RGRX at about 250 million (diluted). It cannot stay at that level, because on a trial win it proces that it works, and Ora Inc has down two trials with it in dry eye. And the data set (outside of infererior cornea) hopefully show significant efficacy, with a 30 day dose, and NO SIDE EFFECTS at all. That is huge. It will put Allergan's $1.5 billion drug Restasis out of business. It will steal any share from Liftegrast. Liftegrast has mixed efficacy, biut apparently approvable. It is a VERY long dose time and it has minor side effects. Dry Eye world mkt is closer to $2.4 billion (per Shire execs). So if our trial is a clear winner, and it goes only to a value of only $245 million ($2.25), Allergan or Shire will be battling each other to take out TB 4 somehow. Novartis eye unit, Alcon, is alsoi another serious interested party. And if TB4 proves up in eyes as a healer and anti inflammatory, it opens that heart and neuro might work too. Combined, they have to be at least $6 billion annual market....MS, strokes, heart attacks are huge $$. So all in all, IF we win trial, 2.00 is very low. And TB 4 is 100% safe and side effect free. That is 50% of any FDA approval.
Bo still believes that NITE offering 40,000 on the ask, is a long sell. Ha Ha. It's just a short offer "cap" to protect -- what they are already short. A lot.
Just up on Ora Inc website..they are presenting 11 poster abstracts at the upcoming ARVO conference first week May. Our results out by then..but it looks like to late to be included as any "late breaker". but if the trial is a winner, all the players will be at ARVO and it won't stop Ora from talking about it. I bet that Shire and Allergan both have used and know & trust Ora.
Sort of as I expected. 44k shares trade. 28.4 shorted. Mostly that was off of NITE's 40k "cap & short"" offer.
PHEW FRIDAY. I get nervous around fridays now. Old Wall Stret "saw". if you have BAD news, you release it AFTER the close on FRIDAY. if you have good news, you do it on a Monday.
no bad news today.
wait till you read this. I WAS LOW! Some of these PEDIATRIC REVIEW VOUCHERS hav sold for $350,000,000. You are NOT selling your drug rights, ALL YOU DO is give up about one year of FDA aproval process. Delaying ONE year of possible sales to an orphan pediatric drugs is no big loss of revenue. but a BIG PHARMA withh pay up to $350 million to GET a BLOCKBUSTER drug selling much FASTER! The kicker is it has to be a PEDIATRIC disease and somewhat rare. PEDIATRIC GLAUCOMA FITS ALL THAT IS NEEDED!. And since TB 4 is 100% safe and side effect free, the FDA will love that.. What we do not have is any human data that TB 4 will effect intraocular pressures, which is Glaucoma. If it ever did have effect on that pressure, FORGET ADULT GLaucoma for now! Go for PEDIATRIC GLAUCOMA and get Orphan status. You get a far less than 100 patient trial, all sped up. If it looks like it works, SELL YOUR PEDIATRIC VOUCHER to a big pharma for $350 million! READ:
"Pharmaceutical companies are paying big bucks to get their hands on government-issued vouchers that speed up the approval process for new drugs. The vouchers, which are given for free to companies that develop treatments for rare pediatric or tropical diseases, are selling on the secondary market for as much as $350 million, reported the Wall Street Journal. The “priority review vouchers” reduce the Food and Drug Administration’s decision deadline to six months from the usual 10 months, which means drug companies gain an extra four months of sales. The fast-track review doesn’t guarantee an approval. Drugs still need to meet the FDA’s standards. The programs were put in place in 2007 and 2012 with the intention of driving more innovation in underfunded areas by rewarding companies that create new treatments. "
This is too great for us...IF the trial works out. I checked with ARVO. there are over 170 Exhibitor booths. The exhibition hall is open to all starting at 9 am today! Ora's booth is in a cool place. It is very big, bigger than most others. it is in section 4b. Ora's booth is huge 20 feet x 40 feet. To the left of Ora is Genentech/Roche..but directly across from Ora...maybe 5 feet away, is ALLERGAN's booth! AGN booth is only 10 x 20 feet. Further down is Shire's booth, not near..and only 10 by 10 feet. One aisle away for ORA is Alcon/Novartis booth.
But the KEY here is that for Sunday to Thursday..........Ora people will be five feet away from ALL the Allergan and Restasis people. Ora can't give a poster presentation on TB 4, but Ora certainly can hand out a PRESS RELEASE, if the trial is out and a success. Allergan will be getting it in spades and IN THEIR FACE if the trial works out. There s NO possible way they won't know about it, as fast as we do. It will be for four full days.....and I have no doubt, if the trial is good, Doctors will ask AGN people what TB 4 coukd mean to Restates. If our trial wins, and they announce for ARVO Monday or Tuesday.....You can expect that the CEO of Allergan will know about it very fast. he will start crunching numnbers ASAP. WHAT will he do with the $40 BILLION he get's from TEVA?