Good find. Novartis will soon be sirttng on $20 BILLION of cash, after selling their large Roche stock stake. Interest rates around Europe are NEGATIVE.which means NVS might have to PAY to put that money in the bank.
RGRX's valuation at $44 million is a rounding error from $20 billion.....$200 or $300 million is still a crumb to NVS. They need pipeline drugs...and they aren't getting what they hope from expensive in house research.......especially in Opthamalogy. the total prce they ended up paying for the ALCON Eye division was $50 BILLION....It hasn't gone as well as they hoped. Alcon has fallen behind. Novartis had no qualms about spending $50 BILLION for Alcon eyes...and Alcon is desperate for more eye drugs.in particular for GLAUCOMA and DRY EYE.
FYI..the eye NK is dosed FIVE times a day....not four like others. Might help a lot.
"A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into affected eye(s), five times a day for 4 weeks."
trot....there, I got the early eye NK test you refer to. That waas not a registered FDA trial...it waas just approvd by FDA as a "Compassionate Use"....they did do 6 people....results quite good. four did 28 days (NO TORTURE CHAMBER)...and two were dosed 49 days..... I asume the two that went 49 days were the worst cases:
"RGN-259 has also been used to treat neurotrophic keratitis (NK) patients with non-healing ulcers under a “Compassionate Use” IND. Dr. Steven Dunn, a corneal specialist, treated 4 patients for 28 days and 2 additional patients for 49 days with RGN-259. The eye ulcers either completely healed or demonstrated significant improvement by the end of treatment or shortly thereafter (See figure below). During the 30-day follow-up period patients remained healed even though the treatment regimen had been completed.
Trot.are you thinking of teh SEVERE DRY eye small trial? 9 patients? That was a 28 day dose......and then they did a 28 day followup. results:
"Statistically significant differences in sign and symptom assessments, such as ocular discomfort and corneal fluorescein staining, were seen at various time points throughout the study. Of particular note were the differences between RGN-259 and vehicle control 28 days post-treatment, or the follow-up period. The RGN-259-treated group had a 35.1% reduction of ocular discomfort (symptom) compared to vehicle control (p = 0.0141), and a 59.1% reduction of total corneal fluorescein staining (sign) compared to vehicle control (p = 0.0108) at 28 days after treatment showing that the repair was sustained long after treatment cessation.Consistent with the reduction of ocular discomfort and fluorescein staining at the 28-day follow-up visit, other improvements seen in the RGN-259-treated patients included tear film breakup time and increased tear volume production. Likewise, these improvements were seen at other time points in the study."
It's all in teh trials. It takes a few, ite seems, to get right design. I think it is a NO BRAINER that the next trial will NOT have the Day 29 CAE Torure machine.which ruins chances of your trial. they will do like Liftegrast and TAV drugs......patients are "all natural"....NO CAE!
With no CAE, it also is probably a safe bet that they extend the dosing trial 29 days to 40 days. every bit helps. they won't use the 0.05 mg dose.but probably 1 mg dose....I'm wondering if they might not try a 1.5....but that is a problem, because FDA doesn't want dose ranging studis in a final phase 3.
Looking at the sweethart deal Allergan got for the trial design for final trial of thei TAV.....then how can FDA NOT allow same for TB 4 next and final time???
FYI...in 2013 Shire paid 4160 million for Liftegrast, before any late stage trials....2013. This $160 million does not include milestones or royalty or bonus payments..."Ornskov (Shire) has been an avid buyer of ophthalmology drugs, despite a mixed record in the field. Lifitegrast--acquired in the SARcode buyout--achieved mixed results in a Phase III dry-eye study and is now under FDA review, despite some doubts about its ability to deliver."
".....mixed results in a Phase III dry-eye study and is now under FDA review, despite some doubts about its ability to deliver."
So why is RGRX at $44 million? Our data is equal to or BETTER than Liftegrast and we have later stage trial data...and Ora can now design the winning trial design with this info. If Liftegrast was $160 million , PLUS....RGRX should be $250 - 4300 million.and add in some kind of value for heart and neuro. we'd get to $2.50 or $3.00......I'd be happy at that price range, as long as we get a "back end "CVR to participate like a royalty, for about 10% of any future possible TB 4 revenue.
"RESULTS Compared with vehicle treatment, AcSDKP treatment initiated 1 hour postinjury significantly improved sensorimotor functional recovery (Days 7-35, p
New Henry ford research, published May 20 Journal of Neurosurgery, Dr. Chopp and his team. Seven years he has worked on this TB 4 area. he's probably as angry at Finkel as we are. PLEASE talk to NOVARTIS Dr. Chopp. Forget finkelstein. He has no idea what to do with your 7 years of neuro work:
"OBJECTIVE The authors' previous studies have suggested that thymosin beta 4 (Tβ4), a major actin-sequestering protein, improves functional recovery after neural injury. N-acetyl-seryl-aspartyl-lysyl-proline (AcSDKP) is an active peptide fragment of Tβ4. Its effect as a treatment of traumatic brain injury (TBI) has not been investigated. Thus, this study was designed to determine whether AcSDKP treatment improves functional recovery in rats after TBI. METHODS Young adult male Wistar rats were randomly divided into the following groups: 1) sham group (no injury); 2) TBI + vehicle group (0.01 N acetic acid); and 3) TBI + AcSDKP (0.8 mg/kg/day). TBI was induced by controlled cortical impact over the left parietal cortex. AcSDKP or vehicle was administered subcutaneously starting 1 hour postinjury and continuously for 3 days using an osmotic minipump. Sensorimotor function and spatial learning were assessed using a modified Neurological Severity Score and Morris water maze tests, respectively. Some of the animals were euthanized 1 day after injury, and their brains were processed for measurement of fibrin accumulation and neuroinflammation signaling pathways. The remaining animals were euthanized 35 days after injury, and brain sections were processed for measurement of lesion volume, hippocampal cell loss, angiogenesis, neurogenesis, and dendritic spine remodeling. RESULTS Compared with vehicle treatment, AcSDKP treatment initiated 1 hour postinjury significantly improved sensorimotor functional recovery (Days 7-35, p
CVR's are totally liquid. NVS coudl buy out RGRX cheaply...and then issue ONE CVR for each share. NVS get's none, shareholders get one CVR for each share. With dilution.call it 120 million shares. Your RGRX shares woudl get bought out...decent bit higher than where we are now.....and they give you back a CVR in place. it becoms tradeable on probably OTC BB just as now. A CVR could get probably a 10% royalty on ALL future sales of TB 4..in ANY indication that someone like NVS controls. It woudl not include Lee's royaly or Kore..and NVS get's then on a buyout of RGRX. It is the best way out for us now. we get bought out at a good premium.NVS get's rasonable risk price......we get issued CVR's that still participate in any upsaide sales of ANY TB 4 application.The likes of NVS will be able to nail the trial and design 100% next time.
Gosh I hope so. But you're looking at 30-90 days if there ever was a buyout....by someone like Novartis....because it will take that long for their reserachers and finance staff to dig thru every bit of trial data.....It also means they probably want to meet w/ Dr. Chopp of henry ford to get his insights on th eneuro area....and they probably woudl need top talk to Drs. riley and Smart in england to dig intp their heart work. There's also a heart dr. in TX and Calif who has done a lot of heart work. can't spell his name. the key on a buyout is that RGRX can sell out perhaps VERY cheaply.....as long as the buyer grants a contigent value right....CVR..a royalty fund basically on any future TB 4 revenues.maybe get 10%.
Finkel is a "deer in a headlight"..blind..... he's probably just waiting for the time restriction on rodman and their research report.....to then let rodman do ALL the work for him.which at the rate of share price now , will probably have to be 15 million shares.....deeply discounted from mid 40 cents.....and with tons of further dilutrng warrants attached...the easy way for him.....but horrible dilution......but he never get's diluted that badly......because we just issue him MORE free stock options every year.
Finkelstein's abilities are non existent. I can't beieve our good fortune that the worldwide Novartis Opthalmalogy divison is based 23 miles from Ora.. A war room should be set up at Ora (of NVS) for the NVS researchers to come and really dig in TB 4. Ora has TONS of work on TB4, and that includes PRE CLINICAL work and MOUSE studies we paid them for!!! But it won't happen.
The only other choice is if someone is able to get thru to the Rodman analyst (email adress in report?) and show him this stuff on Liftegrast.... and show him how AGN has "massaged" all it's numbers for it's TAV drug. Clearly, because we SEE IT IN HIS REPORT ON RGRX..the Rodman analyst has done no independent study on the trial facts & data of TAV and Liftegrast.....Ora might help a little bit..but they are in a bind. while they can find or see easily where Shire and Allergan play "fast and loose" with data......Ora is doing Allergans trial..and shire may have been a client too. And why hasn't ORA stood up and mentiond that the single largest contributor to either a failed or muddy dry eye trials, has been THEIR DESIGNED CAE TORTURE CHAMBER! Ora has collected tens and tens of millions $$$ from clients to do trials, that Ora themselves then ruin....on Day 29 CAE chamber......the two final trials of TAV and Liftegrast.....are being done in the LATEST BUZZWORDS for success....."Natural Settiings"...meaning NO CAE TORTURE CHAMBER!
Finkel would rather take the easy way....dilute the heck out of us.....RODMAN as banker sells shares a couple dimes on the dollar..and then issue tons of further diluting warrants on top. Pitiful. just pitiful.
My day dream is that perhaps thse new poster "biostockz" perhaps might be a professional investor and has access to the Rodman analyst....and someone open his eyes! Right now, he's just a chump stumping for AGN and Shire, because he shows THEIR drugs as a significant risk to TB 4. It may just be the OTHER way around.and HE hasn't done the REAL trial digging.
It also wants to mahe me SCREAM...."What teh F is wrong with you RGRX?" . Teh worldwideheadquarters for Novartis's opthalmoilgy divisoin is in Cambridge MA. Ora is 23 miles north, in Andover. Ora has deep ties to Harvard Medical school. The Novartis Opthalmalogy head has ties to Harvard. A known eye dr., from Harvard, was a doctor in our trial it seems...he wa quoted positively about our results. Novartis is desperete to build up their eye division (Alcon). Novartis will soon be sitting on $20 BILLION of cash - they NEED to find new drugs..., after the sell their Roche stake soon. Novariys wants to be in dry eye, but a big focus is GLAUCOMA.which RGRX did a quick measure on in our trial. RGRX is valued at $45 million. To Novartis's $20 billion that is the cost of a dinner out and movie. Novartis also has interests in neurology....which will bring in heart and neuro potentially to try. BOTH areas are PHASE 2 READY DRUGS and 100% safe. Go look and see how many PHASE 2 ready heart or neuro drugs are available to acquire, that are 100% safe and side effect free. I bet you find tew.
I've no other option but to declare this stock "cursed", and Finkelstein incompetent. RGRX should be going to NYC, to Rodman. Have Rodman set up some one-on-one visits.....then HOST A LUNCHEON for 30-40 investors and explain all. AND BRING DR. GOLDSTEIN AND LET HIM TALK THE SCIENCE. WHY HASN'T RGRX EVER DONE THAT BEFORE - IN FRONT OF INVESTORS! Just plain IDIOCY!. Goldstein invented it! Present GOLDSTEIN and send Finkel out of the room. Then you'll see some investment interest.,
Just goes to show you that:
1. Instituional investors aren't that smart. They don't dig.
2. Analysts aren't that smart. They don't dig. They trust what a co. says.
3. Analysts and Instituional types, even hedgies..pretty much "buy" what a company tells them.
4. It proves how important a COMMUNICATOR is to have as a CEO..and EFFECTIVE one. RGRX loses on that score.
5. It also goes to show how dumb Allergan is.because they know they "fudge and twist" data, to impress Street. but RGRX data isn't fudged. But if you take out of RGRX where AGN themselves was twisting data...then take out Day 29 torture chamber......then TB 4 out perfporms the Allergan drug. How could AGN not be digging intop this.with RGRX at a $45 million market cap?
Another glaring disparity.... that is hurting RGRX is teh Rodman analyst report. In it....he tried to be "fair".....and he posted some "cons" about RGRX..the MAIN one was other drugs and all he did was CUT AND PASTE whatever the company posted of what a wonder drug & result they had..but the Rodman analyst never DUG into them....to see that they twisted all the data..and indeed had NOT nmet endpoints. But he bought it hook, line and sinker...copy & paste whatever Shire or Allergan say of their drug.....but then in RGRX drug? he warns with very prominent mention, of missed endpoints.......but other positives......but he never mentions missed endpoints that were ALSO seen in Liftegrast and TAV. Only TB 4 get's mentiond for missed endpoint.
I swear..........RGRX is cursed.
Allergan did and is doing teh same thing with the TAV drug they got from Mimetogen. That drug failed pretty obvioulsy it's phase 2 as well.....TB 4 results were actually BETTER. Bausch and Lomb initially liscensed the drug from Mimetogen......then Bausch & Lomb studied it harder and decided the drug wasn't good enough.....so they dumped the deal and returned the drug to Mimetogen.....later on, Allergan.desperate for a Restasis replacement drug............bought the rights for TAV from Mimetogen...then AGN twisted the results....TAV also got screwed in the Day 29 torture Chamber.....but AGN twisted more data..then somehow they got the EASIEST phase 3 design I've ever seen for a dry eye.......it's like someone got paid off $$$ bribed.... It sure looks like the TAV win is "in the bag"...but the great news is that the FDA is establishing a precident for what they will accept now for Phase 3.......if it is good enough for AGN and their TAV....the FDA can't reject RGRX and TB 4 for exact same design.
And we go down today. It's really big news that the world wide head of Novartis Opthmalogy is in Cambridge MA........a short trip to Ora in Andover... SO WHY ISN'T FINKEL EXPLAINING the Liftegrast and TAV issues to the doctor at Novartis Cambridge? he can trot up to Ora HQ and see every patients result.
Finkel probably has no idea Novartis head is there.
Well, there you have it....our best chance of making it. Read:
" In December, 2006, he (Dr. Dryja) joined the Novartis Institutes for Biomedical Research in Cambridge, Massachusetts, where he is now the Global Head of Ophthalmology Research."
23 miles to Ora headquarters is the:
"Novartis Global Head of Ophthalmology Research."
I WILL REPEAT FOR FINKEL!
23 miles to Ora headquarters is the:
"Novartis Global Head of Ophthalmology Research."
ONE MORE TIME FINKEL......you are kind of slow:
23 miles to Ora headquarters is the:
"Novartis Global Head of Ophthalmology Research."
The doctor who is in charge of Novartis opthalmology is dr. ted dryja.....he has SIGNIFICANT tie sharvard Medical school, Mass General and Mass Eye and Ear. If you remember the PR from us and Ora. and the end is quoting a Dr. from HArvard Medical School on how good TB 4 was........where the Novartis head also has deep ties. here is the bio of Novartis's head of opthmalogy research in USA...SO close to Ora:
"Thaddeus P. Dryja, MD is a physician and noted biomedical researcher. He is recognized for the 1986 discovery of the Rb tumor suppressor gene, mutations in which lead to a cancer of the eye known as retinoblastoma.
Thaddeus (Ted) is a magna cum laude graduate of Yale College and earned an MD degree from Yale University School of Medicine (1976). He did an ophthalmology residency at Harvard Medical School (1978-1981). After fellowships in ophthalmic pathology and in molecular genetics, in 1983 he joined the faculty at Harvard Medical School and the staff at the Massachusetts Eye and Ear Infirmary in Boston. At the Infirmary, he headed a research lab studying the molecular genetics of hereditary diseases of the retina, and he practiced general ophthalmology and ophthalmic pathology. Major accomplishments from his research laboratory included compelling evidence for the recessive nature of oncogenic mutations at tumor suppressor genes like the retinoblastoma gene, the identification and cloning of the retinoblastoma gene, and the identification of 17 different genes responsible for forms of retinal degeneration (e.g., retinitis pigmentosa) and retinal dysfunction (e.g., stationary night blindness).
He became the David G. Cogan Professor of Ophthalmology at Harvard in 1993 and a member of the National Academy of Sciences in 1996. In December, 2006, he joined the Novartis Institutes for Biomedical Research in Cambridge, Massachusetts, where he is now the Global Head of Ophthalmology Research. Dr. Dryja is also currently a Professor of Ophthalmology,.. at Harvard..."
a blurb from Novartis in Cambridge:
"Most people will tell you they value eyesight more than any other sense. And yet approximately 285 million people around the world suffer from vision loss, including 39 million individuals who are blind.1
Our ophthalmology team focuses on understanding the biology of eye diseases such as diabetic retinopathy, retinitis pigmentosa, dry eye disease, uveitis, glaucoma, and age-related macular degeneration (AMD). We strive to develop therapies that will halt—or even reverse—the ocular damage and degeneration that eventually leads to blindness. “Disease by disease, we’re making progress toward eliminating blindness,” says Ted Dryja, Global Head of Ophthalmology at the Novartis Institutes for BioMedical Research. "