Wow, this could be great news for RGRX and TB 4! In a large trial, RESTASIS only increased tear production in dry eye in 15% of patients! That means <<85% DID NOT RESPOND>>! Basically, the drug failed in 85% of patients, but the FDA obviously saw a MAJOR unmet medical need so they approved it! Now it's $700 million! Furthermore...it seems that RESTASIS can have some side effects (TB4 apparently does not).
ALL this is VERY good news for RGRX and TB 4. because the FDA has laid down a VERY LOW BAR for approval, via it's approval of RESTASIS with only a 15% response rate..with possibble side effects. I think this is GREAT news for us. Read:
Topical cyclosporin (topical cyclosporin A, tCSA) 0.05% ophthalmic emulsion is an immunosuppressant, marketed in the United States by Allergan under the trade name Restasis. Approved as a prescription product by the U.S. Food and Drug Administration in 2002, the drug decreases surface inflammation. It is thought to work through inhibition of transcription factors required for cytokine production and T-lymphocyte maturation. In a trial involving 1200 people, Restasis increased tear production in 15% of people, compared to 5% with placebo.
Usually, 1 gtt (drop) of Restasis is instilled in each eye twice a day, 12 hours apart. It should not be used while wearing contact lenses, during eye infections or in people with a history of herpes virus infections. Side effects include burning sensation (common), redness, discharge, watery eyes, eye pain, foreign body sensation, itching, stinging, and blurred vision. Long term use of cyclosporin at high doses is associated with an increased risk of cancer.
>>>Tc, they have already said they would partner the phase III dry eye trial...they will arrange for such after results from phase II...<<<
That makes sense--they couldn't do it on their own. The phase II results would have to be good + any patent issues be laid to rest before big pharma would sign on, though.
>>>you and sno are looking at things again from 2 different perspectives, yet are both correct<<<
Lol, I disagree. Sno's position and mine are pretty much mutually exclusive.
>>>FDA as judges are also moved by common sense as well as evidence...<<<
That's not my experience! :~P The FDA very rarely deviates from its guidelines. DNDN/Provenge is the only example I'm aware of in years, and that was when a survival benefit was seen even though the trial was measuring a different endpoint. That wouldn't happen here.
>>>your statistical analysis is spot on<<<
Yup (he says modestly).
I doubt sno, even if he grasps it, will ever be able to accept it, though. Tc
Tc, they have already said they would partner the phase III dry eye trial...they will arrange for such after results from phase II... and you and sno are looking at things again from 2 different perspectives, yet are both correct...and if phase II follows along the same lines of results as previously ascertained, with no cure available on market for dry eye, we may see Sno's theory hold water...yet your statistical analysis is spot on...FDA as judges are also moved by common sense as well as evidence... hey, everyone have a great day, enough in world to be down about...
Lol, sno. There's simply too many conceptual, mathematical and logical errors in your last post to spend time on, and most of them are self evident. So I'll focus on the most important one: the concept of statistical signficance.
>>>Forget your arrogance. It still stands. RESTATSIS was approved by the FDA. on a 1,200 person trial.....where only 15% of the people responded. 85% did not respond....The KEY is, and I did NOT lie ...is that the <<placebo>> in the RESTASIS trial got a 5% response. So while you try to play a****hole ....I am FULLY aware of the "Statistical" significance. 5% vs 15% is significant.<<<
I'll explain it to you one more time, sno, as simply as possible. Not so that you'll understand--you probably won't--but so that others will know, if they don't already, how much credence to give to your ravings.
Statistical significance is the level of confidence you can have that a certain result didn't happen by chance. Two percentages standing side by side don't give enough information to determine if the difference between them is stat sig or not. You need to also know the population from which those numbers were taken.
Here's an example. Let's say you find a coin in the street and flip it coin 2x. It comes up heads both times (100% of the time). Is the coin being flipped normal, or do you have a trick coin that has been balanced to come up heads more often than tails? At this point you simply don't know. You need to flip it more often to find out.
That's what clinical trials do. The FDA usually requires a trial to have a 5% or less chance that a trial result was achieved by chance before it will accept that the drug candidate in question proved efficacy in a trial.
As I said before, the Restasis trial achieved a stat sig result (p value .05 or less) BECAUSE, even though most people weren't helped, the trial had a lot of patients (1200) in it. That hypothetical coin was flipped a lot of times, and a relatively marginal difference between drug and placebo happened often enough so that it was deemed not to have happened by chance. Had there only been 100 patients in the trial the result would have been less definite, and wouldn't have acheievd statistical significance.
>>>>>> WOW! Approval bar is LOW!...Basically, the drug failed in 85% of patients, but the FDA obviously saw a MAJOR unmet medical need so they approved it!<<<
Do you get it now that that's totally wrong? Or are you going to continue to mislead people about the FDA "lowering the bar" for dry eye drugs?
You never did check to see what the p value of the Restasis trial was, I assume, btw? Tc
>>>You are lower in integrity than Weiner. I have never ever scoured/searched/lurked ANY yahoo stock to SEARCH >>for you>>, as you do me. I have NEVER posted under more than one name.<<<
Nope, you just habitually lie about your supposed investment successes on message boards and try to bully and browbeat people who point out inconveneint-to-your-ego truths, not caring that by doing so you might be costing friends $.
PPS--does RGRX have the financial resources to do a ~1000 phase 3 patient trial in dry eye?
As I said. You are lower in integrity than Weiner. I have never ever scoured/searched/lurked ANY yahoo stock to SEARCH >>for you>>, as you do me. I have NEVER posted under more than one name. For some reason , you seem the need (NO FEAR).... to do so under up to a dozen different names.
I posted the link to where you basically slander on the OB board. I gave dates and times. problem is? After you posted, over a month or so. I did pretty well. Of course you never say.
Forget your arrogance. It still stands. RESTATSIS was approved by the FDA. on a 1,200 person trial.....where only 15% of the people responded. 85% did not respond. RESTASIS is now a $700 million annual drug.
The KEY is, and I did NOT lie ...is that the <<placebo>> in the RESTASIS trial got a 5% response. So while you try to play a****hole ....I am FULLY aware of the "Statistical" significance. 5% vs 15% is significant.
But if you look back over the years, there are drugs that the FDA refused because they ONLY got a 15% response..FORGET the placebo comparison..... The FDA said it was not significant enoug, or that 85% or people DID NOT RESPOND, to approve.
Furthermore....RGN;' already has done HUMAN compassionate use trial, in eyes, thatshowed not just a 70 RESPONSE rate....but a <<70% CURE rate>>>.....where no drug worked previous.
SO? Lets handicap that you scum, peeping Tom. RESTATIS needs 15% response over 5% placebo (your vaunted statistics)...a similar area, IN HUMAN..as compassionate use....TB 4 got 70% CURE rate (not just response rate) So it seems I have the down slope from 70% cure rate....to a 15% response rate.....of TB 4 failing. In DRY EYE......it is CLEAR what the placebo will do because there basically aren't many therapies.
I figure I have a LARGE cushion to gamble on. Placebo 5% in RESTASIS. RESTASIS got 15%...similar HUMAN trial TB 4 got 70% CURE. Subtract 70 from 15....I figure I got a 55% leeway for a gamble.
How would you feel if someone lurked... and fixated...and stalked - your child....as you so easily do??.
BTW? I did a nice trade on OB. I can only hope you shorted.
You are truly a lowlife....and most likely a loser.
Winners don't do what you do on msg boards. Have you ever seen me lurk or scour to find bocamp? or Mia? or any other SCLN poster? Nope. I'l certainly nail them on a stockboard I have interest in. But I woudl never do what YOU do if I saw Mia or boacamp posting on a different stock.
See a shrink..... on your phoebia. Or just grow up.
>>>Anyone that wants to view a real creep....worse tan weiner. Go to the One Beacon Insurance board. On March 28.12:31 pm..and read what Tc writes. The guy is sick.<<<
*Shrug, there's no need. I'll post it in its entireity here.
But people should feel free to check it out for themselves if they think I'm editing it in any way.
Context was sno was being ignorant and annoying on that MB and someone was telling him to shut up when I chimed in.
"Fwiw, snogreen's notorious as being one of the most ignorant investors ever to post on Yahoo message boards, as well as being one of the most obnoxious and self-promoting. If you're long here, be afraid, be very afraid. Every stock he touches withers. Tc"
How does that make me worse than Weiner, sno?
>>>WOW! Approval bar is LOW!...Basically, the drug failed in 85% of patients, but the FDA obviously saw a MAJOR unmet medical need so they approved it!<<<
From your flurry of posts on different topics and your sudden silence about the FDA having a low approval bar for dry eye, I assume you now realize that you were ignorant and wrong and the FDA did NOT lower the bar for Restatis, sno?
Or am I assuming too much, and are we going to hear that the "approval bar is LOW" once again? Tc
Anyone that wants to view a real creep....worse tan weiner. Go to the One Beacon Insurance board. On March 28.12:31 pm..and read what Tc writes. The guy is sick.
and BTW? I pulled out almpst 2 points with divicends added.on a decent amount of shares with low risk.
No point wasting your time with mia or tc; they are both stalkers and haters of sno. They have no position here.
Tc should be more worried with his own investments; exel.
6 deaths in their trial, no PSA resduction, a cash burning current P3 trial that is irrelevaent to prostate cancer, bone scans that most docs dont believe. It will be all over for them when their next P3 for cabozantinub shows NO survival benefit.