They keep buying a little more time. Who would buy these, even at 12%, unless you believed some kind of deal was being worked on and was very close.
A Japanese path to dry eye approval for TB4 would be quick and easy. Much easier to get approval in Japan for dry eye than in the US.
In 2010, Inspire did a trial for their dry eye drug, diquafasol, in the US. The late stage trial missed primary and secondary endpoints. And one primary was only Central staining. We killed that one. So, Inspire cut their losses, gave up the us market, and got approval in Japan in 2010. In 2010, according to Inspire, there were 8 million dry eye patients in Japan.
The point is there are many markets for dry eye, all outside the US have much easier path. FDA sees this and wants more product. TB4 will get approved, just a question of when and how much value is lost before JJ gets it right.
Best path now would be new leadership, but the only way for that to get done is with a buyout. Are you out there NVS or PFE????? Or take the dry eye indication out of JJ's hands by buying JV and EU rights here.
NO, BK not in the cards, so cut out the emotional tirades. If stock action was due to the failure of TB4 to show efficacy, the company would be in trouble. But, this is pure human error, that is easily fixed by a pharma with better knowledge of the FDA and deep pockets. The fact remains a drug that works on many data points in late trials in a huge market, coupled with an FDA that clearly wants more dry eye drugs in the US, will make a lot of money in the future. That is not to say that the stupid retail who sold after data wont continue to sell. Its the nature of these beasts to sell on the lows. But, smarter money is there with cash to buy this pushdown. Timeline is extended here, but at this price, good money will still be made.
RGRX cut in half, and there can be no argument as to why. We missed primary endpoints. We missed these endpoints because these endpoints of staining and comfort after CAE were needlessly used when many other easily achieved endpoints could have been set. Lifitegrast and Visomitin don't use. Back in 2012, PFE did a P2 trial for tasocitinib for dry eye. They did not use CAE, they didn't even use ORA. They had fda approved endpoints of improvement in tear production as measured by the Shirmer test(we passed this with flying colors) and a more easy measurement of OSDI(a couple ways to measure this) (mostly based on visual acuity). Staining and comfort were put into some of the secondary measurements.
JJ is the CEO, so he must accept blame for these endpoints. We passed Shirmer test, why wasn't that a primary endpoint; PFE got fda to sign on. We still don't have OSDI yet released, how was that JJ? We score well on visual acuity, so I am sure a properly, rgrx friendly measurement of that could have been used.
Bottom line here is that new trial set this summer will be better designed and easily met. But, this past trial was set as if rgrx has all the time in the world to do a follow up. There is no sense of urgency on JJ's part.
JJ needs other trial metrics to be released. If Koreans are not giving him the data, he must insist. Glaucoma is a simple pressure measurement and OSDI is a simple questionnaire, someone has data(gtree up a lot yesterday). JJ man up and start acting like a ceo of a company that is needs execution NOW.
Doc, you have a very thin skin. Every time you get a little grief for your consistently misguided info on this company, you threaten to take your ball and go home. So be it.
I wish you were right about china news. But, company, so far, has been unable to execute on any level. So, all of us sit back and continue to wait.
The ONLY reason for hope here is that the new ceo lent the company 150k. And he must see something materializing in the near term, as company out of money longer out.
These could show what might be a new indication for rgrx . Can-Fite Bio(canf) is an Israeli biotech that was doing a dry eye trial (p2) with its drug CF-101. The results were ok, but more impressive for glaucoma, so company through its subsidiary Ophtalix started a trial in 2015 using eye pressure endpoints. They dropped the dry eye indication. This study will report results in June. CF-101 has a slightly different MOA than TB4, but they are both considered anti-inflammatories. If CANF's results confirm that reducing inflammation in the eye has a beneficial effect on eye pressure, this might be very telling for rgrx.
So, since management is mute on this issue, waiting a couple weeks to see what happens in this trial is very relevant.
The Heart was always going to be a longshot. Hugely expensive and lengthy trials. Just look at AMGN's 100 million spent so far on cytk's omecamtiv for the heart that is only passed P2. A better option might be in the Traumatic Brain Injury area (stroke) that Donk suggested; lots of grant money there. And the Koreans have done some good work on TB4 and wounds related to burns.
Well, then you should sell, because there is no way JJ could successfully manage a RS. Algo's and shorts are absolutely destroying some of the best pipelined, cash rich listed biotech's right now.
How is 2 mil on an uplisting going to mitigate shorts.? They would laugh at that. Ziop and XON are just 2 examples(there are many more) of relentless shorting, even in the face of decent news and Large cash balances.
We can get value here by financing through NK results or China start or grants or dozen other possibilities. Then worst case, we get accepted endpoints in a P3 trial over the summer without CAE. That is worth 10's of millions in market cap.
I hope for buyout still as best option, but worst option by far is a RS. Even Kirk got the butt end of share price when he insisted on a RS for aphb. And if he cant manage it successfully, you think JJ can?
Very few successful RS's in the biotech space. If they could get real institutional commitment up front to buy shares on finance deal on new listed security, then maybe. But that is unlikely. The shorts would have a field day on uplisting. Its better to try and execute right here. We can still make a buck or better on our own this year.
In 2008, Acucela's Rebamipide was a promising dry eye drug that was coming off a trial done in Japan. Main sponsor of trial was Otsuka, but in the small print on Clinical.gov we see a co sponsor: Novartis. P2 in Japan was hyped as a big success. It was shown to be "statistically" better and non inferior to eye drops in its one primary endpoint: corneal staining. No real statistically significance by FDA standards. Yet, Otsuka gave them money and paid for trials, leaving Acucela with just royalties upon approval. And, Novartis on board.
It seems Japan has a much easier path for approval than the US. A couple eye drugs that have failed here are selling well there. RGRX may keep that in mind. The Eu is also considered much easier than US, with its "signs and symptoms" qualifiers. Another reason RGRX can not give up EU rights.
Anyway, agreement with Acucela was terminated in 2013 with Otsuka, and Rebamipide written off. Otsuka bought Acucela some time later.
Lots on money has gone after dry eye drugs over the years. We have seen some here in the US by nvs and agn. It just defies logic that a big deal with Novartis will not be how this thing ends up......we shall see.
RGRX should also contact Otsuka. The Koreans would not like that and it might force them to play their hand now.
Sno, the example using Aerie was to show the moving endpoints the FDA accommodates now for eye indications as well as the selloff which proved to be very temporary and misguided. It has a lot of similarities with what we will see with price action here.
If you choose to focus on the glaucoma issue and the fact that Aerie has a 1/2 billion market cap that is fine. Certainly, glaucoma would be a great addition to the rgrx pipeline if recent trial shows efficacy.
Here is just another example of the FDA's increased accomodation in the Eye indication. We have seen it in the relaxed endpoints for Lifitegrast and Visomitin for dry eye. And here is another example in glaucoma. It is also a provides a very likely path for stock action here:
AERI is a 500 million market cap stock that has only 2 products in clinical development, both in the eye area. It has no revs. The most advanced product is for glaucoma (P3). Last spring it missed it primary endpoint for non-inferiority against the standard of care, but(like rgrx) had many good secondary points. Did the market care about the positive secondaries? No. Shares tanked 70%. Then while working on another P3 for same indication it lobbied the FDA to change the ON GOING trial endpoint to the one hit by the failed trial. Press release below:
The biotech announced this morning that the FDA had provided written approval to change the primary endpoint for its second Phase III study--Rocket 2--"to include patients with baseline intraocular pressures ranging from above 20 mmHg (millimeters of mercury) to below 25 mmHg. The former range for the primary endpoint of above 20 mmHg to below 27 mmHg will now represent a secondary endpoint range for Rocket 2."
Shares rallied 50% that day and are still going higher. The moral of the story is that the our short term reaction may not last very long if the FDA keeps its accomodative stance on eye indications. And, CAE is likely to fall by the wayside. And, as i have said before, emotional longs selling on current rgrx endpoints are going to find themselves under invested here very soon, just like AERIE.
Crazy the bmrn is still independant. CEO must be a real PIA as he has rebuffed all offers; and you know there have been more than a few in the last years. But, it will happen. With the new political headwinds around a Hillary win, this may just be the motivation for CEO to cash out...............Be long and patient.
Geezer, you are like a mad old bulldog. Who gives a #$%$? The size of the coverts pales in comparision to the millions of shares owned by JJ, McNay, Goldstein, sigma tau, the koreans. That is the vested interest that will be protected.
If you dont believe that then SELL, and do us all a favor.
Have you not seen one of these types of PR's before? It is standard fare and little else, other than they know of no reason for decline, is ever provided. It accomplished exactly what is was supposed to do; just inform, in a legal fashion, that no bad news is being held back.
If you want more, try and read a 10Q.
Stock action here was not caused by MM's, it was the result of new Rodman longs and some emotional long timers who think they can trade for pennies in the most illiquid of stocks. Its a joke when a stock has a 10 cent spread sometimes and a 5000 dollar trade can take stock down over 10 cents that anyone would have the penny mindset here. But. some longs here are their own worst enemy, and you know who you are.
Have some conviction with the valuation here based on the facts of Gtree valuatuon, Lifitegrast valuation and Visomitin valuation.