Ah yes, that was it. Bausch & Lomb forst took this drug from Mimetogen. Then after a whikle they dumped it back on teh market. They did not want it. Then after LIFTEGRAST came around with a win, Allergan then picked it up in November. I do believe Ora did work on it early on. I checed teh clinical trials website, and I CANNOT TELL if Ora is doing the current trial...but I do see that teh primary and secondary's are almost exact same os ours was. They had no tertiary points, RGRX did. I woudl like to know if ORA is doing it. because if they are NOT, then Allergan got smart, becauae Ora threw us into the torture chamber CAE again, and we lost statistical that we HAD up to Day 27! I woudl like to know if mimetogen/allergan do it that way.....because it sure looks like it screwed up TB 4.
Bo might be up on it. But there was a history of mimetogen. I recall it getting bounced around. First they took the drug, then they dropped it, then they took it back? I'll have to check. Also, I recall earlier trials that flopped in it. not sure of this phse3 they say. but give a chore over weekend to look.
I am hoping that R&R can get an update on teh Eye NK. That is a sleeper. No one expcts it to pass. But only a few dozen patients and it has Orphan status, and it is a FULL PHASE 3 trial. EYE NK is not unlike severe dry eye. We passed severe dry eye very well. That CAE chamber did not help .....only ONE day they used it! for an hour or so. man. But we need that Eye NK signed up.. Finkel gives us nothing on it.
No fueler, it wasn't a home run. The first Restasis FULL phase 3 failed totally! Ours was a Phase 2b/3. With the data gotten from the FAILED phase 3, Allergan was able to design ANOTHER Phase 3 that won approval after. Restasis is now a $1.5 billion drug. Shire's dry eye drug LIFTEGRAST also basically failed it's first Phase 3. with that data they designed a second one, and met with success. NEITHER IF THESE DRUGS EVER HAD A "HOME RUN" in trials! This is what people don't get! Dry eye space is a minefield and teh FDA has finally realized that people need MORE drugs that Restatsis. The data is now in hand to design the phase 3 that will get us. They expect to start this Fall, Unless someone like Novartis makes a play for TB 4. They will see what the data has, and whether they think RGRX is priced right at a $60 million market cap for a $2.5 billion market they want in too.
Interesting point. Which means earliest R&R comment is Monday......but that also gives Rodman analyst all weekend to get his thoughts down nicely, not rushed.
I don't think this failed at all. We had issues....but the data they got where it did win can be used for a final one. Ora says they can replicate data. just need a non guess endpoint to match.
Ora uses the CAE because it does create over the top trial set up capability. No one else can do what Ora does, and the FDA seems impressed on having this CAE machine... is also a way Ora does pre trial work for companies. The FDA can't demand that all trials use CAE, because it is proprietary to Ora. But the CAE (torure chamber to us) chamber is not an FDA mandate for a dry eye trial. So the way RGRX stated it is this.......from Day 1 to Day 28...in severe dry eye population, TB 4 was at a 0.03 P value of reducing overall corneal staining. THAT IS A STATISTICAL WIN!. Then on Day 28 , the patients sits in the CAE chamber for about an hour or so.maybe bit more. They dose TB 4 as usual. THEN the next day, day 29........is the FINAL OUTCOME measure. but it appears that doing the CAE torture chamber day 28, negated much of the effects seen day 1-27. So next time DROP the CAE tiorture chamber! the FDA does not demand it! And average dry eye patients aren't looking to SIT IN A ADVERSE ENVIRONMENT CHAMBER during their flare ups anyways!
Just more BAd luck to RGRX. But I think now they have all they need for the final one. And the EYE NK may surprise too
It would not surprise me if someone knew something, somehow. At 1:00 pm to 4 pm, they sold about 300,000 shares.in a BIG rush.....from around 70 cents down to a low print of 45 cents, then we came back. I woudl cal it a "GMO" order......Get Me Out. But one poster here is in often contact with FINRA about shorting.....and because of that FINRA was watching RGRX trading. It woudl be very easy to trace back that account & seller. Whether it happens or not, who knows. The trial did not fail.. endpoint choices did...but it was not the clear win we all hoped for, either. So we go back and wait. And FINALLY, there is enough data for the exact phase 3 approval trial..from this one today
It's been just over four hours since the release. That shoudl be enough time for the Rodman analyst to write a research comment.....he has RGRX as a "buy" for his clients. he's a pro at this.....I'm just hoping that he sees some of the things I think I see in the trial results (or am I crazy)....it isn't "deep data mining"..it's pretty straightforward. if the severe dry eye patients were a separate endpoint, the trial was a big success...Also, it appears that if we did NOT use the torture chamber, Controlled Adverse Environment (CAE) for an hour or so on Day 28......we also would have had a good win in overall corneal staining........P 0.03
Will Finkel be able to spell this out to Rodman? When will he put out his note? I hope today.......and perhaps is he has good things to say (????) many scared sellers have sold. I bought a little.
This sounds nuts. It was a 29 day trial. We got the "total" (overall) corneal staining measure NAILED up to day 28. quote:
"RGN-259 had a statistically significant reduction in corneal fluorescein staining prior to entering the CAE on Day 28 when compared to placebo (p=0.034). "
But then on DAY 28*, they "entered the Controlled Adverse Environment Chamber..called CAE.so we are in that chamber ONE damned time during Day 28, and then on Day 29 measure you lost all the previous 28 days of a winning overall staining? Patients don't have to be in the CAE in daily life day 28, we have a BIG statistical win..a P value P 0.03. They sat in the horror dry chamber for an hour or so day 28.and it screwed up their eye all over again!. ANSSWER? if FDA does not require it, DON'T USE IT NEXT TIME AND WE HAVE A BIG TRIAL WIN!
It is still big. Shire estimates the world market is really $2.5 billion. And getting bigger as baby boomers age. It is only about $1.5 billion now because Allergan's Restasis owns the whole dry eye market..but the efficacy isn't so good in Restatis, and it has severe side effects. 35% - 40% of sufferers cannot use it. TB 4 can still be huge., even with moderate to severe popuation approval. TB 4 has NO side effects..NO safety issues... Upcoming approval Liftegrast showed it's Phase 3 that 53% of Liftegrast patients had side effects, but not badly serious. Liftegrast was also dosed for a FULL YEAR..365 days. TB 4 was dosed for a mere 29 days. PLENTY of room for TB 4!
Bo just posted that we flip flopped this time and got good result in teh INFERIOR region cornea, unlike last time. But bo writes that we had a miss in overal corneal staining. READ CAREFULLY what RGRX stated. It resads to me liek we GOT good statistical results in total corneal staining, BUT it got missed when they put patients in teh Controlled ADVERSE Environment chamber (CAE). SO? The FDA does NOT demand or require that trials have to use the CAE. Only Ora uses it. So if it is not required by the FDA...and it seemed to mess up this one...then next time, since it is not required, DON'T USE IT! read carefully what RGRX said:
""RGN-259 also improved a common objective endpoint – ocular surface staining after 28 days of dosing in patients with compromised tear film break-up time at baseline. In this population, patients receiving 0.1% RGN-259 had a statistically significant reduction in corneal fluorescein staining prior to entering the CAE on Day 28 when compared to placebo (p=0.034). "
SEE? READ AGAIN. WE HIT OVERALL STAINING BEFORE CAE!:
"In this population, patients receiving 0.1% RGN-259 had a statistically significant reduction in corneal fluorescein staining prior to entering the CAES on Day 28 when compared to placebo (p=0.034). "
SEE THE WORD, "PRIOR" to entering CAE.....we had total corneal staining P value of P 0.034.
That is a trial win! if the FDA doesn' require CAE, don't use it next time! Simple.
Restasis is a $1.5 billion drug and does not work that well and has significant side effects. Restasis failed it's first full Phase 3. Took that data and desiged the next one to pass. Liftegrast basically failed it's first Phase 3, technically, too! It took a second Phase 3, designd off the first...to make it for seemingly FDA approval soon.
What I get at is that the eye area has been a graveyard of drugs and trials. The FDA knows that and has loosened somewhat on their trial demands. Both Restasis and Liftegrast needed TWO phase 3's each to "get it right". This trial of TB 4 was technically a Phase 2b/3. we are following right along the same path as Restasis and Liftegrast. Nothing in this trial shows that TB 4 did not work....what it showed is were TB 4 works BEST.and interestingly, it is in the hardest to treat dry eye patients....not in the mild to moiderate cases. Weird. The Rodman analyst will understand this..and so will someone liek Novartis. The baby should not be thrown out with the bathwater on this resulst of TB 4. In reverse? the roadmap was just given for approval trial.severe dry eye. And Ora has said over and over, that their results are replaceable. They replcate what we got today in severe dry eye, TB 4 is a huge winner. But I sure woudl like to hear what I am thinking, from the Rodman analyst. Hope is research update comes soon.
and the next trial will focus more on severe dry eye! which RGRX clearly got a big win in!
Come on Rodman.....if he agrees with me and explains it in his client note, RGRX coudl be up on the day!
the EASIEST to treat dry eye population supposedly is the MILD to MODERATE cases. TB 4 it seems did not do as well as hoped in the mild & moderate dry eye population. However, in the SEVERE dry eye population, TB 4 was a resounding success. Who knows why. But the ENDPOINT FDA design INCLUDED ALL mild, moderate and severe dry eye patients. Supposed statistical was not made because in 2 of the 3 subgroups.mikld to moderate wans't what hope. So because of that STRICT measure of ending, peopekl think it FLOPPED! BUT IT DID NOT! RGRX released all the P values for the sub group of SEVERE dry eye, and the statistical evidence was a BIG WIN! But the FDA cannot say it was a WIN, because the chosen endpoints LUMPED in ALL patients, mild, moderate and severe. BUT THE PATIENTS THAT NEED THE MOST URGENT THERAPY ARE THE SEVERE ONES, because they put their eyesight at risk! And TB 4 WORKED for them! In a mere 30 days, with 100% safety and NO SIDE EFFECTS. If this severe patient group was the sole measured endpoint, the FDA woudl approve TB 4 with NO PROBLEM! The trial did not flop! Only the chosen & guessed endpoints missed statistical. TB 4 worked, in a several hundred patiuent trial, placebo controlled trial!
Rodman analyst..he has a buy on RGRX. His job is now to write up a bried summary report on this trial and results seen. Had the trial been a complete flop, that report could be written and on the wires VERY quickly. But, IMO, since he has not done so, it means he is in contact with Finkel. Only ONE analyst coveres RGRX, so Finkel is well aware how imnportant this analysts views are. IMOI, the longer it takes for Rodman's research update to be released, the better it will read..because he is going to go into more detail and explanation. I bet he says good things! And if he does, RGRX may be up on the day! Just have to wait and see. But longer it takes for his update, the better and more thorough it will read, imo.
If the Rodman analyst is speaking with Finkelstein, as I am SURE he is..Rodman is too important now to Finkel..the Rodman analyst will see what I see. or, Finkel will clue him in. IF THERE WERE NOTARBITRAY CHOSEN ENDPOINTS teh trial was a win..because the hardest to treat and MOST AT RISK PATIENTS OF RISKING SEVERE EYE DAMAGE..showed over the top, efficacy, safety, short doseage time and P VALUES. The FDA will see that and look kindly that the next and final trial shoudl proceed ASAP with their blessing! AGAIN! Has SEVERE DRY EYE been included as ONE SINGLE ENDPOINT MEASURE.....this trial was an OVER The TOP WIN! Do you think the FDA will THROW TB 4 out the window because of lesser efficacy measure on moderate to mild dry eye? WHICH SUB GROUP WOULD THE FDA WANT TO SEE A THERAPY FOR ASAP? The ones at the biggest risk of PERMENANT eye damage..SEVERE DRY EYE! And we won big time there.
I bought more. This trial did NOT fail, only some selectd endpoints failed. I do NOT think that Restasis or LIFTEGRAST has much success in SEVERE DRY EYE patients, but mild to moderate. On the other hand, TB 4 may not have had great success in mild to moderate dry eye......but the trial CLEARLY WON BIG time in the severe dry eye population, but the were NOT the "primary" guessed and chosen endpoint!. THE FDA WILL SEE THAT! The FDA will WANT to see any drug come along for theWORST & hardest to treat of patients. even better? for SEVERE DRY EYE? Tb 4 was 100% safe and side effect FREE and it was a mere 28 day dose! LIFGETRAST is a 365 day dose! This trial was a WIN, not a flop. the flop was only in a patient sub group. SEVERE DRY EYE won big time!
I don't do twitter or know how. But what I am quite sure of is that teh Rodman analyst is in contact with Finkel and Finkel is taking his call and running him thru the whole thing. IMO, it will become apparent, as it did to me and the PR....that this trial was ONCE AGAIN messed up by guesses in endpoint targets. I don't blame Finkel or Ora......but this severeal hundred patient trial clarly showed that TB 4 passed with FLYING COLORS all of the severe dry eye patients! IT DID NOT FAIL THEN! It is several hundred patients of data. And now the next and hopoefully last trial, will be TB 4 in severe dry eye. Ora says they can reproduce these results. If they can, TB 4 will pass FDA review easily. But I want to see Rodman analyst come top the same conclusion? IF HE DOES and puts it out, we won't be at 46 cents for very long.
Of course they will.....TB 4 showed ALL the statistical P value evidence and safety, in treating the SEVERE DRY EYE PATIENTS! NVS will see that. Had this trial only been set up targeting severe dry eye patients, it would be seen as a RESOUNDING SUCCESS....by ALL P value measures. Ora states they can reproduce these results. If so, TB 4 coudl easily meet FDA approval of severe dry eye, on the results and P values seen today. NVS will see that, I may buy more..because I am sure if I see this, teh Rodman analyst will too. I am anxious for his report on this.