I think you will see a comment on Monday by rodman. They are or have been talking to JJ today. There is a lot of info here and many data points to explain to support their bullish view.
This area is the hardest to hit, and we missed last time as other dry eye meds have, but here we see success. I dont know how we could have not hit the endpoint for total corneal staining. A potential big pharma buyer with deep pockets could find alot to like here and easily find the path to approval at the FDA
Additionally, a change from baseline analysis (Day 28 minus Day 0) demonstrated a statistically significant improvement in inferior corneal staining for the 0.1% RGN-259 treatment arm when compared to placebo (p=0.003). This finding was also observed at Day 14 compared to placebo (p=0.035
There are some good data in here in the subgroups.....especially 28 days after CAE exposure using the 0.1% solution (p=0.0072).
The FDA will ) likely guide them to look at the 0.1% solution after CAE exposure against placebo in an intent to treat population. Meaning, comparing patients who needs treatment for dry eye (with the placebo being the guy who needs it but got water instead). It is VERY VERY good that they hit the number here, since this will likely be the primary endpoint for the p3.
These study results suggest that RGN-259 has the potential to help a wide variety of dry eye sufferers," commented Dr. Joseph B. Ciolino, a Cornea specialist at Mass Eye and Ear and Assistant Professor of Ophthalmology at Harvard Medical School.
NCT02597803) demonstrated statistically significant improvements in both signs and symptoms of dry eye with 0.05% and 0.1% RGN-259 compared to placebo in a dose dependent manner during a 28-day dosing period
Fair enough. I dont think if you have been here 10+ years, another month or 2 makes any difference at all, especially in the world of bio's and rgrx. JJ may have mispoke in terms of timing of trial results, but i think dealing with the Koreans has turned out to be a little more challenging than he thought.
Many American Ceo's have learned this the hard way, not just JJ.
If i had a dime for every post over the years that warned of common shareholders destruction at the hands of the wicked "insiders", i'd be as rich as Trump. In biotech, fortunes are made before any revenue("profits") ever get realized.
Gtree and the Italians own most of this common, they are not looking to BK themselves today to see revenues generated 2 to 3 years out. The value of rgrx is now.
"Everyone should just settle down and wait for the results. If your nerves can't take the uncertainty, sell now and go on your merry way"
Those are your words.
Yes, that is really standard and very helpful protocal for biotech companys; the ceo putting out a PR saying he has no idea when trial results will be announced. Have you ever invested in a biotech before? If you had, you would see many extended timelines. Maybe it would be helpful if you stop making naive posts about a very common situation in the biotech world. And name calling is pointless and not very productive.
Great price action today. Big buyer at 70 cents
You need to calm down. Have you ever invested in a biotech before? Timelines are always being pushed out, its the nature of the game. Situation here is further complicated by having a Korean partner that may have a different view as to when to release data. And, as a junior partner in the JV, rgrx may have little control.
Delay just points to other negotiations taking place that would not be taking place if results were negative.
No release this week....IMHO...................no big deal