CAE use was misguided. We all get it. It seems pointless to keep repeating that sentiment, but have at it.
We do not know if JJ and Koreans were forced into using CAE, as other early trials on various dry eye drugs did use it. But the focus now is that it will not be used in the future trial, There is no precedent for using such and adverse environment in other trials. Does a diabetic have to drink multiple Cokes in the last week of a trial to see what happens to insulin levels. How about a week of sun for a melanoma trial? Or a nice pack or two during a lung cancer trial/ The whole concept is ridiculous and will be dropped here.
And NK will never get around having a placebo arm. Just take a look at what the FDA made srpt do in their new trial? And if they were forced to use, you can bet the FDA has not interest in cutting rgrx a break on that point.
And finally, stock is not maintaining this market cap waiting for 2018 and beyond. Once easy FDA endpoints agreed upon this summer, trial will be almost totally derisked and JV or rgrx will be sold. Gtree is not waiting that long. They are not going to get a sales force and sell TB4; that is silly.
Recent finance gives jj the waiting time and negotiating leverage he needs. He did not sell off another "piece" of rgrx's pipeline or dry eye coverage on the cheap.
Wait continues, but lots of positives to look forward to. Of course some fixated in that rear view mirror will choose not to look ahead. So be it.
More unusual OTM call action today. 1200 july 110 calls. With stock down, buyers paying up .23 cents at .45. Offer now 50 cents
IGEN revisited. Recommendations do little, short interest up. Roche is up to their old games again. It is in their best interest to have stock as low as possible during negotiations. As with IGEN, Roche was caught illegally shorting stock to put pressure on Igen to accept lowball offer. Roche plays hardball and flaunts regulations.
I have never seen a penny bio come with this size placement, under the market(that is usual) and do less than avg volume on the day. Normally, you see many times avg volume. Along with the lack of volume, price action was very subdued, again pointing to a dearth of traders and very committed longs; not a bad thing.
It would be nice to know the buyer. I do not think it is Kirk. He is having a handful with the poor price action in his biggest holdings; ziop and xon. He has almost become toxic on the street now as his many recent promises have fallen very flat; notice all the lawsuits involved on those 2 companies. Also, shorts are all over his holdings. So, just as well it aint him. When i was corresponding with JJ, we talked about the need of placing stock with a real buyer, not an atm like Lincoln. He was very aware, so much so that I think he might have sacrificed a couple pennies on the deal to get the right buyer. Action today suggest that. IMHO
What was lost today was also an unusual item on this type of deal. Sno, you must have noticed? These deals are almost always announced after the close and most often on a Friday. But here, JJ put it out loud and proud on a Monday morning; start of the trading week. No attempt to hide the deal. Good job on that one. Price of deal must have been run by the Koreans, so they are ok with that and the buyer. And they have a serious vested interest in success here. So, nothing to do but hang tight and wait for positive news to hit. No going concern statements anymore.
Great Video, and sadly reminds us all why we originally invested in this stock. Phrases like "evidence overwhelming" and real "impact on health", are just inspirational. It really just shows how lacking leadership has been at VASO. I hope Ma takes a look before he cashes his next check; or should I say his next 30 pieces of silver.
How do you see that? Renew can advertise as increased quality of life for healthy patients. Vaso would have to apply for same as angina is there target market. Huge difference if you really want to market eecp to the masses. And vaso has shown NO inclination to spend money or time applying to the FDA. Ma sold us out to Leiberman, Castle and the investment bankers. But, why should he care? He gets nice fat salary.
"The Renew® NCP-5 is the only ECP system with a cleared indication for the use in healthy patients."
I know, we are not an EECP company anymore. Ma lied to all of us on his commitment to EECP, and now other companies have pick up the slack. How has Ma's new corporate strategy help shareholders the last couple years. Ma, Castle and Leiberman are a disgrace. What could have been with the right vision????
FARMINGTON HILLS, Mich., June 21, 2016 /PRNewswire/ -- Renew Group Private Limited (RGPL) today announced that The Renew® External Counterpulsation (ECP) Therapy System received a new clearance from the FDA for the treatment of healthy individuals. In addition to the well-known indication for the treatment of chronic stable angina, the Renew® ECP Therapy System is also "intended for use in healthy patients to provide improvement in vasodilation, increased VO2 and increased blood flow." The Renew® NCP-5 is the only ECP system with a cleared indication for the use in healthy patients.
Thanks for updates. They don't seem to have put the recorded CC on the website yet. I thought I heard that trial results will be out now at the end of this month; next week. Did you hear that also. If so, could be some movement in share price ahead.
Supply does seem endless. And the only ones with that type of supply would be insiders, but we have seen no Form 4's. There is no way legally they can be putting stock out without being in violation of sec rules. And if it is the Syrbniks, they will face some serious consequences from aggrieved shareholders.
Koreans have done and paid for everything they said they would. It would have been impossible to have found a better partner, given the dire straights rgrx was in at the time of the agreement.
These trials will be expensive. The Koreans will go forward with every intention to do these, but I don't think they will get a chance. Once they get solid agreed upon endpoints with the FDA, I believe they will sell the JV. They don't need final approval or an NDA to get top dollar. Both Lifitegrast and Visomitin were sold well before P3. TB4 can easily hit 2 bigtime endpoints: increased tear production with the Schirmer test(notice that recent translation of yours mentioned tear increase) and total corneal staining or comfort score. There will be no CAE.
RGRX or Gtree will never see a dime from revs from dry eye in 2019. A big pharma has the luxury of waiting for those revs. Dry eye will be monetized by rgrx and gtree well before that. So, once endpoints are known this year, stock should react accordingly.
Lots of news pending on other fronts also; heart, stroke, burns, glaucoma, OSDI, grants, patents......
UK itself is a relatively small market for pharmaceuticals, limiting the fundamental impact. The UK population represents only about 15-20% of the addressable Western European drug market, and with drug reimbursement tending to be slower, more restrictive, and lower, the actual impact of the currency shifts in the British pound and/or any changes in treatment patterns is likely to be even less than this.
So, rgrx rights to the EU are still very valuable, even without UK. And JJ is free to negotiate with UK or can sell rights to Gtree for more lunch money. But, keep the EU for top dollar.
A real positive divergence here. Almost a 4% decline in the market on Brexit, and only 1 small seller showed up. It goes to show that weak hands who traded on the Rodman coverage and those long time longs here who bailed are not going to buy back cheaper. Holders now are content to wait for pending positive news.
As long as the US-Korea Free Trade Agreement stays intact, the brits leaving the EU means little to rgrx or Gtree. This is one case were the East beats the West and many may be looking for good buys in that area.
Gtree selloff was on small volume. May see more for them on Sunday. but no meaningful reaction here.
Ands now 50k takes out offer at .16. Man, someone is really playing this stock. I would say without a doubt this looks like a bottom, but with vaso, who the hell knows??????