More good news. in february 2015 the Indian Gov't loosened rules on some drug approvals. for rare diseases, India will now accept a U.S. Phase 3 trial for a marketing approval in India. it seems that the Eye Nk trial would qualify. The FDA gave it orphan Drug status here. With the massive population of India, Eye NK must be an issue.
From India PR:
"India’s Drugs Technical Advisory Board (DTAB) has recommended granting Phase III clinical trial waiver to some drugs approved in "well-regulated" countries like the US or EU.
Prior to granting a waiver, the CDSCO would have to obtain input from experts in the therapeutic area for which the drug is indicated. The DTAB recommendation is similar to what the Chaudhry Expert Committee, tasked with overhauling the drug regulatory system in India, had proposed to the Ministry of Health last year. The ministry countered that such a waiver should be limited to national health emergencies and for drugs indicated for rare diseases."
EYE NK is a rare disease.see above last sentence. So if our FDA approves TB4 .ever..for Eye NK....we are able to apply for marketing approval in India off that trial and approval.
There are similar guidelines with the European.....EMEA. but not sure the exact details.
I just played around Ora site and google. I coudl find no previous trials for a new drug for eye NK. Not that Ora can't do fine, just they don't seem to have done one before.. Checked further and there is no real therapy for NK. Except Tetracycline and then surgery
:treatment for stage 1 neurotrophic keratopathy:
• Topical lubrication with preservative-free artificial tears, gels, and ointments
• Discontinuation of any topical ocular therapies, especially those that can decrease corneal sensitivity (eg, timolol, betaxolol, sulfacetamide, diclofenac, ketorolac) or that contain preservatives
• Reevaluation of the need for systemic drugs, such as neuroleptics, antipsychotics, and antihistamines.
• Punctal occlusion may need to be considered.
• Oral tetracycline (250 mg PO bid) or doxycycline (100 mg PO qod) can reduce the amount of mucus produced
• Weyns et al proposed scleral contact lenses as a valid long-term alternative to standard treatment options in patients with neurotrophic keratopathy.
• Gaudilla et al note 20% autologous topical serum is an effective treatment for stages 1 and 2 neurotrophic keratopathy.
Stage 2 treatment is as follows:
• All of stage 1 treatments
• Topical tetracycline reportedly increases the healing of epithelial defects (not available in an ophthalmic drop preparation)
• Topical cycloplegia with atropine 1% or scopolamine 0.25% once daily in the presence of anterior chamber inflammation
• Patients with stage 2 disease are more likely to require surgical intervention than are those with stage 1 disorder
Treatment for stage 3 neurotrophic keratopathy is as follows:
• All of stage 1 and stage 2 treatments
The previous not a good read for bonkers. RGRX is decently covered in EYE NK for patents. not great, but covered. Since the FDA granted Orphan Status...no matter what....if the FDA ever approves it for EYE NK, on the date of approval...the company get's seven years exclusivity....which is enough to make some money. I think it is a good bet that RGRX lawyer has filed for a patent relating eye NK...and the important thing there is that the USPO protects those companies that are 'First To File" . which means that even if the USPO rejects inital claims by RGRX, no other company with better lawyers can step in and file over RGRX and take tb4 in eye NK. if RGRX is first in line to file relating eye NK..they have that placeholder secure, and then just have to fight it out at USPO. but in any case.....if ever approved EYE NK, RGRX get's 7 years exclusive. the DOPES at USPO....RGRX will maximize revenues if they only get 7 years, which means HIGHER $$ cost to treat a pt w/ TB4. But if the dopes at USPO grant a patent which runs about 17 years....RGRX can price TB 4 much lower for eye NK. Leave it to the gov't themselves (via USPO) to screw consumers and insurance co's. the V.A. run by Feds....is largest drug purchaser in USA. The USPO will screw the VA!
In 2008 the FDA gave RGRX a 'compassionate use IND" to treat a handful of pts with Eye NK. the results (humans, not mice) were very good. The FDA later gave TB 4 Orphan Status for EYE NK and also approved a Phase 3.( which Ora Inc will do) and it doesn't seem to have to be a huge trial. To give some comfort for this EYE NK trial..here were the results from compassionate use IND in 2008. Humans, not mice.
"RegeneRx Biopharmaceuticals, Inc. announced today that its ophthalmic drug candidate, RGN-259, was used to treat four neurotrophic keratitis patients with non-healing eye ulcers caused primarily by the herpes zoster virus under a "Compassionate Use" IND (Investigational New Drug application). RGN-259 is a sterile eye drop formulation of Tβ4 being developed by RegeneRx for use in treating ophthalmic wounds and related disorders.
Dr. Steven Dunn, a corneal specialist and the sponsor/principal investigator of the IND, utilized RGN-259 to treat the corneal ulcers that had not healed for at least six weeks and in some cases several months, despite all standard treatments. In all four patients, the eye ulcers either completely healed or demonstrated significant improvement by treatment day 28, the maximum treatment period allowed under the clinical protocol. The patients were followed for an additional 30 days post-treatment. The results showed that completely healed ulcers remained healed and those that had demonstrated significant improvement continued to improve after treatment by RGN-259 was stopped. RGN-259 was well-tolerated and there were no drug-related adverse events.
The clinical investigators under the IND include Dr. Dunn, Dr. David Heidemann and Dr. Christopher Chow, of Michigan Corneal Consultants, P.C., Southfield, Michigan; and Dr. Gabriel Sosne, Associate Professor of Ophthalmology at Wayne State University School of Medicine and Kresge Eye Institute in Detroit, Michigan."
something new and different....fight with USPO. TB 4 Fragments are still having questions at USPO. Te latest "non-final" action was at end of 2014. RGRX is still fighting. A week or so ago, April 7, RGRX got the okay for a time extension to craft their reply..and the USPO accepted.. So the battle goes on in Fragments.
Bird flu is not that meaningful to SEB and certainly no reason for a 500 point, idiot trader led, swoon. First, SEB does not own Butterball...they own 50% of it. Where the bird flu hit weas in some contract turkey farmers in MN. I am sure that Butterball has contract farmers growing turkesy all over the south and midwest.. And teh farmers who got hit probably have some insurance.....and look this way. if demand stays sanme.......and supply turketys falls a bit...then prices rise and Butterball makes money.
I've always been in teh game. Never left. Hold into six figures of shares.foir a long time. I don't mind buying shares at higer prices, if things warrant it. I know lotsa folks bought in single digit cents.....I didn't. Nothing was there. Better things nowLEss risk...but I still want to see teh trial design for China
It was disgusting. I watched this trader do this botched order all week. He is either dumb as dirt, or his firm was in trouble and it ALL had to be sold by today - no matter what the price..... It felt to me like the final PUKE DOWN print came early afternoon, at $3,380...I couldn't take it any longer. I more 8 more shares.tried at that level..but had to pay mid to high 3400's. It is not easy to buy into an almost 260 point smack down. It was like SEB was in major financial or legal trouble..and the seller knew.
When that $3,380 print came..SEB was down $505.00.in five days..M-F.......just doesn't make sense.
if I was Bresky, I'd either sell out to Warren Buffett..and they could structure the deal using BRK.B stock that Buffet buys in open market ahead of deal (no dilution). That way Bresky family get's paid out $$$...they get uber diversified berkshire Hathaway stock to distribute to family....they pay NO capital gains tax until they sell any BRK.B....and Buffet woudl want Bresky to run all of SEB, just as he has for years. Everyone WINS!
if Bresky does NOt want to ever sell...even to Buffett.....then idiots like today and this week..show that SEB is better off PRIVATE. All Bresky has to do is a tender offer for the 260,000 share he doesn't own. he coudl get very LOW interest rate borrowing costs..SEB has ZERO long term debt now....and SEB sits on about $525 million CASH.earning almost nothing.
Steve Bresky! Take SEB private... or sell to Buffet for BRK.B stock.....moves like today aren't fun for anyone. Especially the B family controlling 910,00 shares!
I bought 10,000 as well....and similar yesterday. Got decent fill today at 3:09.pm....at 0.3499 and 0.350....strange though....then 10 minutes after that (or so)...it is .36 bid and trades.38.
I don't think the MM's are aware that there is more dry powder here than they know. the MM isn't on top of lee's...and also that major piece in the journal Cornea..well, the same day that came out online, RGRX traded 1.2 million shares.back around 25 cent area. Now, that was NOT 1.2 million shares from THIS board. That surely was doctors and researchers who get online journal Cornea....and THEY bought 1.2 million that day. So they are still around....and UP about 13 cents on the trade. They LIKED what they read in Cornea.
What I'm getting at is that I bet they will be buyers... if RGRX goes down again....and most of this board has bought or could buy also. I think the MM's will be quite surprised...and for NITE to still be short is dangerous. Lee's shoudl be starting their dry eye trial very soon. And RGRX should not decline on that news. It is just "tick tock" till that trial ends. If it wins, RGRX worth a lot more than $32 million.....not that RGRX will make much money out of China....but that if Lee's works, odds are far better it will in USA. And RGRX still owns ALL European rights.
Thanks for sharing...but may be best in future to keep the reply to yourself. You can summarize and give teh gist, though. Lee's trial start is key.it seems I am the only one who thinks so.
Wow. Bresky family holding down almost ONE QUARTER BILLION DOLLARS - just today. Monday, SEB traded $3,885..today SEB just traded $3,380............amazing. Either the dumbest trader in the world, or something very bad is happening at SEB and the seller knows about it. i don't think so.
SEB now down $500 on the week...family lost $455,000,000 in 5 days. I don't feel so bad!
If I was Mr. Bresky, I'd use this idiot seller to the family advantage. Unless there is something the seller knows and we don't...I don't think so.
this is good news....'drplano" seems to have contacted RGRX:
"SNO, I had a reply from Mr. Finkelstein that news from China are expected within this Q To the best of his knowledge and a news release will be put once that starts."
I said I hoped within 60-90 days. But it may be sooner. Lee's got preliminary Chinese gov't okay for trial back in JUNE 2014. Those that play down the China trial importance are wrong. It is the first and soonest one that will show results in dry eye using what we learned in the first Ora trial. if they design around that, and where there were problems..then chance of sucess increases. Further, pollutuion alone might give TB 4 a leg up over placebo. Placebo water drops won't do much. So once Lee's announces they are SIGNING PATIENTS... the clock ticks for the shorts like NITE. It won't be a huge trial...patients plentiful in China to get... Lee's is organized. results by end of year? So for all those that keep harping on the two Ora trials coming..if we are LUCKY you won't see any results on those... tll to late Spring... or mid 2016. Focus on CHINA now. A statistical & successful trial by Lee's.....hugely increases our 'win" odds with the Ora trials. ora wants that China data, I am sure.
Tick Tock shorts! there's also a surprising amount of dry powder amoung posters here.. I'm not sure how much MM's will get by staying on the bid side. Market down 265 and RGRX isn't moving down at all.
Even crazier...Monday...5 days ago.SEB trading at $3,885. friday it trades $3,505..down 380 points....or 10%..for what? 380 points times 907,000 owned by family a loss of $345,000,000.00
Thats just nuts. But thos prints to $4,600 were nuts too. Too thin. Too volatile. SEB is better of taken private for teh family, or sold to someone liek Buffet who will let the family still run it.
SEB is down OVER $1,000 a share from the high 9silly) print now. teh family is down 4165 million just TODAY alone. Insane. if Bresky would not consider selling to someone liek Buffet, then he is crazy not to consider just taking SEB private and be done with trader insanity and all SEC headaches. Bresky controls over 77% of SEB. All he has to do is buy 260,000 more shares and he takes it private. he coudl do it in a heartbeat.....easy and cheap financing is tere...because SEB has NO long term debt and sits on $525 million of cash and is earning no money really. if I were him and I didn't want to sellout at a premium to someone like Buffet.....I'd bid for the 260,000 shares and take it private. least that way they control it from these idiot trader sellers..and the net income of SEB was about $300 million last year and that coudl be distributed to family, after CAPEX stuff. Don't know why Bresky hasn't done it. I would.
Crazy. As I've said, the seller here is an idiot. And teh short is turbo charging downward on small prints every time the dopr advertises more for sale. But the Bresky family must be wondering. On just today, the value of teh family trust is losing $165,000,000.0...that is a big number. teh seller is not clean yer. we've traded about 250 shares only. On the bell yesterday he advertised he had 456 shares to sell...so we got a couple hundred more at least. At some point there is 5,000 short, and they will buy some. Also possible that SEB may buy back shares too. SEB still has $50 million authorized for share buy backs. the softness in pork prices does not justify this much of a decline. the collapse in oil makes up for a lot of it - making Seaboard MArine profitable now. It LOST $25 million last year!. And Cuba maybe opening ? Crazy.
i'll wait till end of day to see if I bid some. more is for sale I'm sure. what a whack down!
Yeah, NITE has to be short a good amount still....for a long time they were the ones holding and shorting when RGRX was in the teens cents - for a long time!. they are in a small pickle. They had better cover soon. My guess is that once Lee's announces the China dry eye trial is signing patients, the clock starts ticking. China will be the first up of the dry eye results, and a successful trial there wil give comfort that the US Dry eye will do as well. Lee's has stated last year that they expected to start by tehe end of the 1st Q 2015. That has passed. I am hoping they say they are starting it within 60-90 days. Buyer will be around gambling on Lee's outcome then. It won't be a huge number of pts for a phase 2, and we hope it goes quickly. MAybe result by end of year. And if Lee's trial works, many more will buy RGRX then. $32 million market cap, with a hoped for successful Lee's and US starting.RGRX is too cheap. But we need China to start ASAP. Ora will want their data too.
FYI...the shorts have been on SEB, once they saw this idiot seller. Seller adverrtises he has stock to sell.shorts love it...they sell 2 shares down $75.and the seller follows them down.... Today on NASDAQ, 144 shares traded. of that 142 shares, 92 shares were SHORTED. So that is about 65% of all nasdaq SEB volume was short side. The majority of SEB volume usually is third markets..very little trades on the NYSE listing. and the MM on NYSe rarely shorts SEB. he just sets the opening price auction and closing. Seller advertised he is still here at 3;59...offered 456 shares. As long as the dope keeps doing that.we go down and shorts short 5,000 just have to put up a ONE SHARE TRADE down $50. One share downtick $50...adds a value of $250,000.00 to their short position. Imagine that. ONE share short..tick down $50..gives you a QUARTER MILLION $$$ DOLLAR mark.
until someone steps up to take the fund seller, short is having a field day.
No, FINRA SHO is just updated daily for shorted shares. Haven't checked today yet. Short is all over this now. he sees that we do have a sized seller over time. And the seller is dumb, dumb, dumb. he advertises to the world he has stock to sell. And if tehe EIGHTH LARGEST POSITION in SEB is SHORT.. and all the short has to do is put up ONE share prints down $50 each time..then the idiot seller follows down. Seller is not "clean" yet. The idiot advertised he had 450 shares to sell... on closing settle.DUHHH. You don't think we all saw that, for TOMORROW?? When you sell again??? Did not get taken. So the dope will probably do what he does again. we can nibble small....little risk...but no larger institutional or fund buyer will....becase they have traders smart enough to see that some idioytt sells 2 shares down $75 and then advertioses he has tons more to do similar!. Oh well...ride it out. My cost basis is still far lower
Uhhh..if Ora Inc is the God of eye clinical trials, then why did the FIRST Ora trial appear to be a failure to all of Wall Street? reason is simple. ora had significant input into the trial design.. there are four subsections of the cornea. RGRX and Ora settled on a trial design with the primary endpoint only in TWO subsections of the cornea. the trial (on paper) failed. did not meet primary endpoints.
NOW, RGRX and Ora are going back with a phase 2/3 dry eye. By adding a phase 3 possibility in it, they better darned sure get the DESIGN RIGHT! And every scrap of evidence from ANY human clinical trial will aid them. Matters not whether they use CAE system or not. Trial data from China may be better, in a sense.it is real world massive pollution. And dry eye is such a serious problem in Beijing, that up to 20% of it's population suffers from it. SO YOU AND BO THINK THAT HUMAN DATA FROM CHINA DOES NOT MATTER? Wake up! RGRX CANNOT afford to have another USA dry eye trial FAIL! So whatever you can do to make sure it does not, DO IT. And that woudl to me include waiting on the final USA dry eye trial deaign until you see the results of the China dry eye. WHAT IF CHINA DRY EYE FAILS???? AND ORA IS USING A SIMILAR TRIAL DESIGN???? YOU NEED TIME TO CHANGE IT, RIGHT???? China hopefully is done before end of 2014, so it won't delay USA dry eye that much. Ora can proceed with the EYE NK trial whenever they can. I hope by end of year. That is an APPROVAL trial and it has FDA Orphan Status..so in a sense, it is a more important trial and woudl lead to teh FASTEST drug approval from FDA if results warrant..
China dry eye was supposed to start by "end of first quarter 2014".....let's hope it is in 2nd Q and soon. That will be the first big trial news, and Ora Inc will be all over the data hopefully.
Don't kid yourself on the shorts here! It is almost 5,000..more has been shorted last few weeks. I check FINRA daily. The 2 largest instutional holders don't sell. DFA and FIDO. FIDO owns about 6% of SEB. they BOUGHT about 4,000 in Q4. So if you take out Bresky 77%, FIDO 6% and DFA...that means the float in SEB os less than 150,000 shares.
Now, if there are 5,000 shares short? THAT is BIG, when you consider SEB often only trades a few hundred shares a day. Another perspective? A 5,000 share LONG position woudl rank as the 8th LARGEST institutional stockholder. So the way I look at it is this...the 5,000 shares SHORT would equal to the 8th largest OWNER of SEB!
As soon as this seller dries up, hope soon...the short will not be able to use his one-share-downtick-gasoline-print-down #$%$. if the seller dries up (which he will)...the short has no way to buy really. And I do NOT think the Q1 numbers will be as bad as this seller fears. yes, prok is low, but so is corn.and oil collapse is a cash cow to Seaboard Marine! And the LOWEST oil prices came in Q1. I hope SEB hedged out a ways.