Bo, you think a capital raise:
Since RGRX had no problem doing a PIPE deal - for 15 cents, why haven't they filed to sell stock when we hit 25 cents? They have not filed an S-4 registration. Cleary they don't want to sell stock for funds, at the 20 to 25 cent range….even tho' they have before at 15 cents. Which means that they are waiting for something.and their estimation is that it will be bigger than "25 cents"……..or? if the news they have is not want they want.raisng a couple million dollars won'trt save them anyways., and they go BK and auction off assets.
I don't think news is a partner deal. Too much time has passed (YEARS!) with no partner interest. IMO? It is either a total buyout (see Jan 3 posts on that)…o..r RGRX gambles that they will win a marketing approval in England for Dry eye….and instead of a market cap of $18 million..a marketing approval in a majpr western country…with all IP….should put RGRX at a $75 to $100 million market cap, and easier to raise a few million $ for the Orphan NK eye trial over here. Also, Lee's might be able to use the England possible approval, for one in Hong Kong. The Brits set the whole drug review system up there. It might explain why Lee's has NOT done any trial work or testing with TB 4 dry eye….they may just piggy back off England??…IF (a big if) that pans out as hoped.
Please don't misconstrue what I say. I've never said approval is "just around the corner"….all I have shared and pointed out to you all to is that there seems to be a possibility of a marketing approval review in England. I am hopeful of it…but I never stated it was a slam dunk.
I haven't sold either… I am all or none. It either works or it is a tax loss.
yes you probably are right..that is there was something really enticing.…something would have happened by now. It's why I have posted that whatever the news is RGRX waits on….I don't think it is a TB 4 "Partner" news….because had any one been interested in partnering here..it woulds have happened already. I think either the company is for sale (read the JANUARY 3 poster saying that)…or RGRX waits on this possible England TB 4 approval in dry eye.
Sure seems like 2 years wasted. I am surprised no one made any offer to partner TB 4. Even if low…If you read the article it wasn't that bad a result on Ora trial. I think restasis is close to a $900 million drug now for Allergan.…and there were patent issues. And Restasis has side effects…. so a large population of dry eye pts won't take it. And Restasis only helps replace the tears……it has NO healing ability as TB 4 did. So TB 4 actually a more unique drug. It has no side effects. Restasis does not heal and has side effects, and it is a $900 million drug! Go figure. OH! Restasis is not without it's own checkered history. As I recall Restasis FAILED it's first Phase 3 trial!….. RGRX was in exploratory Phs 2..but for Restatsis to fail it's first phase 3….that's bad. But all love it now because it is a $900 million drug. I am surprised that Allergan hasn't made a play . AGN sits on over $2 billion cash and their stock near all time highs.
It is further along than you think. The "pre referral draft scope" is done and in….the draft remit is done….the important 'Scoping Review meeting" was held on Jan 8, 2014. The process for this approval was started OVER one year ago…..so we are well along.
TB 4 is not being looked at as a COMBINATIOn therapy , putting both TB 4 and cyclosporin in the eye together. Two separate entities. Cylcosporin is going generic soon.and it also has side effects where many cannot take it. TB 4 has none.
You can dig deep in the NICE website and they have flow charts of the process of Technology Approvals.
It is still my opinion that it is not a good thing to do to contact regulatory people that are involved in reviewing your drug. It puts her in a bad spot, that I am sure she won't appreciate. And the last thing we want is to put the TB 4 approval meeting at any kind of risk….or question. NOT a good idea to try and "hit her up" for information - so you can trade stock off her input. Bad idea. Potentially very bad…and your email is traceable - in a jiffy.
No, I have not emailed her. I think that would be a very bad idea. That person knows they are dealing with possible drug approvals, and such news can be market moving. I am sure they are under strict orders for disclosure of things. Also, we don't want to bug or #$%$ anyone off over there……to where it could put RGRX, and the whole possible approval…in a bad light..…or even worse….at risk. I think a bad idea to contact them. Let RGRX handle them.
The NICE is pretty open about posting things on their website….we can still find out things that RGRX mgmt will not tell us…but it is public knowledge once posted on their website. The confusing thing is the timing of this possible meeting. The Brits are a maze of "meetings, memos and postings"..and they strecth on and on….unlike our FDA…for approvals the FDA schedules an open meeting. They get input from their Advisory Committee….the FDA reads.…FDA has a meeting (public invited)…then the decison comes….win or lose. The Brits don't operatte that way at all……
we're going to need real news to get it to "really move"…it may look like there aren't many offers out there…but no doubt the MM's will be around offering if we tick up a handful of cents. Still, it's nice we are hanging around 20 cents….still levitated, with silence from mgmt. Folks on this board already are chock-a-block full….to get new buyers, we need new, news.
I don't get the sense that there are many long time readers & posters on this board who have sold any shares.…whether at the recent 25 cent (above) or not. Most are long time suffered…..and if they were not selling for tax losses at 5 cents in Dec 2013…are unlikely to sell any..until they get the "final" news. Either RGRX survives….or it goes BK. I've said often I an 'all or none". I think others feel the same. We've got profits elsewhere, so just use the RGRX writeoff.
Good luck in getting more shares. Who knows. But you have to balance that out….is it worth waiting for 4 more cents down or so.…which is $4,000 only on a 100,000 share buy……but your risk is that maybe whatever it is the news RGRX has been waiting on..happens before… And you don't get any shares. RGRX might have something else in their pocket, besides what I have found going on with the possible England marketing approval meeting. One poster thought RGRX was soliciting buyout bids (see Jan 3 posting) But RGRX only did a $40,000 band aid financing in early January…to get them thru February. So it might be the "news" they waited on to do the $40,000 financing…is out by end of Feb…..you might not see 14 cents befre that. But who knows.
I can't get a decent timeline read on when this England things is decided. They do not work like our FDA. Our FDA sets the meeting date, and that's the whole ball of wax…you win opr lose. Everything get's dragged out in England.
school…not everyone knows what this board knows in regards to a possible England approval meeting. But we don't know the exact timing. So when RGRX gos up 500%..2 to 25 cents…recent buyers, and older holders…..get anxious for the reason why it jumped 500%. if no news comes out to support the sharp up move, people get antsy. The longer there is with no "significant" news, the more likely it is there will be more sellers. Just the way it is. Me? i'm going all or none here….Joe McNay knew the news they wait on and he put his money down..RGRX knows what the news is and they know we have an $18 million market cap - up 400%. RGRX has not filed to sell stock. why? They sold stock before at 15 cents, why not 25 cents? IMO? they wait on the news.
It is always p\ossible someone will know what is news from England before us. Matter of fact? it's a GIVEN.…because RGRX mgmt does not wish to disclose that material news possibility. Any other small speculative biotech would. If I see any info on meeting dates, I will post. But none yet.
Wasn't really a walk down…because about 80,000 shares traded just over 20 cents……in a few trades…they weren't 200 share "print scam downs". Actually, someone played a "mark up" game….and bought 1,000 near the bell up 2 cents from those 20 cents prints.
I assume that 80,000 or so sold at 20 cents was a long seller? But it would be very interesting if it turns out to be an opening short sale on that downtick print. Don't know. we'll see what FINRA stats say for the day.
There was, what the Brits call…a 'Scoping Meeting"….I said jan 7…but correction, it was January 8…..but this whole British process is so different than anything we do here.. All these different agencies are involved….and all these papers and pre - meetings, and postings. So I can't say how long it woudl be after the January meeting. But we also saw that there is a sub group called the 'Borders Group"….. they meet every other month, on the second Wednesday.so that woudl but their meeting a week from today….Feb 12…..but I can't say for sure just what power this Borders Group has….it reads like they do Scotland.
It is interesting to see British Bureaucracy in action. I thought USA was bad….but the Brits have NHS, NICE, UKMI and Borders groups…all in on this TB 4 action.
It can't be THAt long away from decision.…as RGRX mgmt knows the details better than us, time & decision wise..and RGRX did the latest band aid to get them thru (close) february.
the thing that intrigues me most is that RGRX seems unwilling to sell shares to raise desperately needed survival money.at 25 cents. RGRX has previously sold stock at the 15 cent level in PIPE deals…why is RGRX not willing to do so now at 25 cents? They have literally no money in the bank. Which all then points to the possible England approval…you think it is a #$%$ shoot. But on the face of it, RGRX mgmt doesn't think it that big a #$%$ shoot..otherwise they would be selling stock right now to raise money. RGRX mgmt is looking at England. If they thought the chances slim to none there, they would sell stock right now. They aren't. So RGRX mgmt seems to have more confidence that you. I'm tempted to buy more, but haven't , yet.
I hope it is a comforting sign that RGRX has not filed a stock sale registration (S-4) with the SEC yet. One would think that any all but broke biotech, that saw it's ahares go from 5 to 25 cents..with just a handful of thousands $ in the bank account..woud soon file to sell millions of shares at the 25 cent level. But they have not…yet, anyways. Hopeful sign? MAybe RGRX is waiting on bigger news? Like this stuff going on in England, which could come out with news sometime soon? RGRX is waiting on some kind of news. And if they aren't rushing to sell stock when the price is up 500%…..are they waiting for more? We still are only a $19 million market cap. If it is an England marketing approval decison for TB 4 in dry eye, with NICE….then that news would put RGRX's market cap a handful of multiples (easy) beyond our current $19 million market cap. I take it a hopeful sign…NO registration to sell stock at 25 cent level..…(so far). Something bigger may be hoped for? I think RGRX is gambling on that. Don't tell the MM's - who are shorting RGRX..RGRX seems not willing to sell shares at 25 cents.
53,500 shorted yesterday..almost 1/3rd of total volume. Not sure if NITE was active….there are other MM's around now, who also think that any, and ever..y…penny stock biotech is a POS…..and just short them all with impunity. Actually, if you did that with 100 penny stock biotech's…..you made (make??) good money……You'd lose on a few….but overall..…they all go down….and comfort is that most other MM's think the same way. So they all play the same game & way. Short. So they all will act to try and cap moves.
It's absolutely hilarious that the SEC now reports that the "official short interest" in RGRX is 0……..ZERO….not one single…. solitary…. 25 cent share….. is short in RGRX.
There were TWO patents in the neuro area file. One by Henry Ford, one by RGRX. RGRX was slighty ahead. Henry ford filed under their name, but did so under the auspices of the RGRX legal firm. HF did not assign theirs to RGRX. The HF patent was give a rejection at USPO. So far, HF has not replied to that..so after a certain amount of time, the USPO considers it abandoned. RGRX was given the patent. You might not see it yet because RGRX got a "notice of allowance"…which is different than "patent issued"..because RGRX has some paperwork and fees to do first.
Damn Yahoo won't allow links to be pasted. So try this, you can see and maybe youy google a snippet off it to find it exactly, then you can click on TB 4 for dry eye.
"Proposed Technology Appraisals
These are the topics which the National Institute for Health and Care Excellence has been invited to appraise. For each proposed appraisal, the table gives the suggested remit, the dates of the consultation on that remit, an e-mail address to send any enquiries to regarding the proposed appraisal, and links to any documents being consulted on in addition to the suggested remit.
Atrial fibrillation (non-valvular, stroke and embolism prevention) - edoxaban tosylate
Breast cancer (adv, taxane resist) - vinflunine (w capecitabine)
Breast cancer - bevacizumab (w trastuzumab & chemo, adjuvant)
Cardiovascular events - cangrelor (with surgery)
Cardiovascular events (secondary prev) - vorapaxar
Constipation (opioid induced) - naloxegol
Crohns (mod, active) - adalimumab (2nd)
Crohns (mod, sev, active) - vedolizumab (2nd line)
Dry eye syndrome - thymosin beta-4 & ciclosporin A"
I do not see where the NICE talks of doing a "trial"…the NICE says they have four choices after their review….They approve the drug….they grant limited use of the drug….they allow the drug only for research purposes…or they reject the drug for all uses.
Seeing how TB 4 is totally safe…..I don't think the options of "limited use" or "only research use" would apply….I think they either approve TB 4 for dry eye , or reject it. But teh data presented to NICE was the datat that was over the top good…and teh seriopus dry eye tests. The NICE didn't seem that concerned about the tiny sub section of cornea (the inferior) where statistical wasn't seen. They appear more impressed with the over the top good data seen in the central corneal region.
RGRX mgmt should not be silent on this possible TB 4 marketing approval meeting with NICE (it seems).
I am halted by yahoo. I CANNOT post the link. I'm sorry. I tried THREE times. TB 4 is being reviewed for it seems approval, under BATCH 34 drug group, and the final SCOPING meeting was held January 7 in the afternoon in London. You just have to dig or trust me. Yahoo stinks in they halt any link posting..it is too long.
Here is why I thinbk it is a marketing APPROVAL and not just recommending a final" trial". because the technology appraisal does not talk of trial, but they give RECOMMENDATIONS….of which trhere are four. Recommend for use…."optimize" (only for limited or special cases)….or only to be used in research…..or rejected. Below is how they phrased it:
"Each technology appraisal may contain more than one recommendation. We classify our recommendations into four categories:
• only in research
The final info meeting (or scoping meeting) was Jany7 7 in London. If it helps, TB 4 is listed in BATCH 34 of medicines in review. All I can find is that NICE has reseleased results of medicines before them for BATCH 32.