It now appears to me that all you are going to get on the first 66 patients is safety data. No efficacy data will be forthcoming. This is not great news. It has now been almost 5 months so it is impossible to believe they are still analyzing the efficacy data on the first 66.
We have not heard that they reached the 88th patient yet. The second analysis (whenever that occurs) will make a recommendation on trial size. That will be the one to watch.
The P1 data should be coming out soon so that may give you a pop but the stock will come back to you. As for me, I'm happy I got out at 10 and change and will stay on the sidelines awaiting further news.
Getting an intelligent answer from armed lunatic and speed mutt-- Good luck with that my man. I see that DonkeyDon thinks posting ONCY's own press release and then explaining to him what it means is "unbelievable" So be it. Hey it's not my money
You're a funny guy Grim Boy. I have no idea what you're talking about. but of course neither do you. Half the mets didn't make it to the first scan but 8 are still alive 2 years later??? funny stuff. And this fever nonsense that is funny stuff too.
Immediate approval??? hahahahahah that is the funniest part of your entire post.The company told you donkeys that the trial was no longer a registration trial In September of 2012 only true morons (of which there are plenty ) would hope for approval on the basis of this trial. Is English your first language???
Listen real close Grim Boy and write this down.--REO will NEVER be approved for any indication and I'm willing to bet the there will Never be a p3 in H&N. Tell me more about an open label p3 with PFS as an endpoint that will be done in less than a year.. Do you write your own material???
Forgive me donkey if I doubt self serving statements about what happened and did not happen when the company actually has the data and could release it -- but refuses to do so. Especially in light of the super human efforts this gang has gone to in order to avoid giving you elementary and readily available data.
But here's something for ya grimboy . Something simple to entertain the simple mind-- find me one word about "fever "in a written press release by ONCY. It's almost as easy as coloring the unicorns horns without going outside the lines!!!
Extra credit for you if you can show me a reference to "30 days" in any press release.
Facts is facts Grim Boy and of course Mr Market concurs. Which I done tole ya long ago.
You got splainins to do. Bu tin the end you could just admit you are wrong and reevaluate based on correct info.
A number of patients on study received additional treatments with other agents following discontinuation of study treatment ONE --in accordance with the clinical practices of individual enrolling centres. IN ACCORDANCE WITH CLINICAL PRACTICE AND KNOWN OR SHOUL DHAVE BEEN KNOW TO ONCY FROM DAY1) Thirty of the 118 patients in the loco-regional group received at least one therapy with other agents after study therapy was discontinued. TWO A greater number of patients in the control arm received post-discontinuation therapy versus the test arm. (MORE CENSORING IN CONTROL ARM)This imbalance created a "confounding," or distorting, effect on OS (CENSORED FOR SEEKING ALTERNATIVE THERAPY NOT "FEVER":) (Pazdur; The Oncologist 2008, 13:19-21), as THREE- such additional therapy can extend the patients' lifespan beyond that expected from receiving the study therapy. EXTENDED LIFESPAN FOR THOSE WHO SOUGHT SUBSEQUENT THERAPY. Eighty-eight loco-regional patients did not receive additional therapy and an analysis of these patients showed a median OS of 150 days (21.4 weeks) in the test arm FOUR (n=50) versus 115 days (16.4 weeks) in the control arm (n=38). 18 CENSORED IN CONTROL COHORT WITH SMALLER STARTING N--12 CENSORED IN TEST WITH LARGER STARTING N
How's that for starters?
Just to remind you the data is a and was available for the censored patients. And please don't be so petty as to note that ONCY said "can extend life" I think we can all assume it did or they wouldn't have bothered to point it out.
You flatter yourself my friend. Knowing that reducing the size of a trial reduces its statistical power doesn't impress very much. In fact belaboring it over three posts only illustrates the extent of your delusional self-aggrandizement. BTW what did I misrepresent about ONCY's public statements?
1) Patients treated in accordance with protocols of the HOSPITAL which were known to ONCY from the inception of the trial.
2) Pts seeking alternative treatment lived longer
3) More in control than test.
4) pts censored because of subsequent treatment not fever.
5) Data is available on censored patients but ONCY refuses to use or disclose it.
Every bit of that is true.
Not to state the obvious but based on the share price it would seem that it is you who needs the luck. I'll leave you with this -- the more or less arbitrary censoring of known or available data based upon the flimsiest of pretenses destroys the integrity of the study. The data presented is garbage. This is a simple fact. Remember longer is better!!!!
OH grim boy there you go with the PFS nonsense. PFS won't get you to the promised land and the results are far from unambiguous. Every radiologist will tell you that there is ambiguity in reading almost every scan. Furthermore on a six week scan cycle, making it past just one scan increases your PFS by 100%. In a trial where progression is expected in about 45 days, the skew introduced by the scan cycle is extreme. This probably eludes you.
But if you dig a little deeper there is even more ambiguity. If you look at the OS's the control arm lived 65 days longer after Progression and the trial arm only 56. Hmmmmmm. Let's see, they progress more slowly on REO but die faster after they progress. Does that make sense? It is as close as ONCY could come to making the data seem coherent in the witches brew they concocted.
Now go back to your Crayons and color in the unicorns horn.
"That is a point worth saying again: censoring of patients provides no benefit (zero, nada, none) to ONC/Y! The company would have been much better off if no patients had violated trials protocols and if no patients had needed to be censored from the trial. This is a simple fact."
Well of course this is just wrong as it pertains to ONCY. If this were "normal" right censoring then the loss of patients would make it harder to achieve stat sig. That is axiomatic. But normal censoring occurs when patients are LOST to follow up and are then presumed to have progressed or died according to one of three statistical conventions. But this is not true in the case of ONCY and this is where you make your mistake, The patients who were censored by ONCY were NOT lost to follow up, they were alive and getting treatment according to the protocol of the hospitals, a fact well known to ONCY at the inception of the trial.
In fact we know two things about the LIVING censored patients from the company's own mouth 1) there were more of them in the control arm than the test and 2) irrespective of which arm they were in, they lived longer. It bears repeating. The censored patients were not lost to follow up! They lived longer!!! There were more in the control arm! Thus we know with certainty from the company PR's that if all the data were used, the medians of the control arm would be increased far more than the medians in the test arm (more censoring and smaller N in control arm) making the results worse for ONCY. This is a simple fact. Personally I think the control arm lived longer than the treatment arm but we'll never know.
I do believe that data that has been subjected to "enhanced interrogation techniques" does confess. Parroting back HR's ids meaningless unless you tell me what is being measured and how the data was treated before measuring. I also understand responsible censoring. Right censoring (type II) is done (almost without exception) when patients are lost to follow up, not because they got alternative treatment (which happens in almost every trial) so you and I will have to disagree on whether ONCY's actions were responsible. I know this much with absolute certainty, if the data was good they wouldn't have tortured it. You are also incorrect about censoring patients because they "violated" trial protocol. In fact clinicians were adhering to the protocols of the trial centers, as Brad disclosed in his propaganda release. Perhaps you can blame this on bad trial design but it was no surprise to ONCY that folks got alternative (better) treatment.
Additionally you are wrong about "fevers" being the reason patients were censored, at least if you believe Brad. Per the company, patients were censored because they sought better treatment and in fact were censored on the day they received the treatment. Now some of that may be a result of fever but it was the treatment that got them censored. If they just crawled in hole and died after they got a fever they would have been counted.
For approval purposes 6 week tumor data is meaningless in the first place and worse yet includes stable disease which establishes nothing. Responsible researchers only look at PR's and CR's so if you throw out the SD's the results are even more horrible than the published results. Of course you won't be hearing how many folks were SD.
YOu seem like a stats guy Why did they measure OS from the median PFS?
Why didn't they give you the actual median numbers for either cohort and in fact use different excuses for refusing to do so for each arm?
Oh my little donkey. I thought you ran away and hid (like most of the old ONCY longs) humiliated by your idiotic predictions on OS for the mets cohort. But it seems not. In boxing we call this leading with your chin. Not to rub your nose in it but Mr market seems to agree with my analysis more than yours. I guess everyone except the 10 ONCY longs on this board must be wrong. I think most forks here (including you, my donkey) are just posers who have no serious money at risk so it's all just fun n games. But seriously, if I had been as wrong as you I'd have kept a lower profile, but that's just me.
tell me some more about single arm open label 6 month p3 registration trial. I haven't had a belly laugh in a few months.
We will see who has the last laugh on IMUC (which so far is me since my basis is 1.08.) and remembering that you don't need FDA approval to see a sharp increase in price.
Howdy stephen! A little jibe aimed at me. It would be more effective if you were on firmer factual ground when you try to poke fun.
I understand plenty about statistical power and I know (which apparently you do not ) that "power" is function of 2 variables. Thus, speaking of power without addressing the size of the effect trying to be measured is either an inanity or an intentional attempt to deceive, (which I suppose is distinguishable from an outright lie) so I will give you that much. But saying that a result lacks the "power" to provide a median OS is as close to a lie as you can get. As a matter of empirical fact the two are not even related. You do not need "power" to provide a median OS. One is a real world fact and can be established by most fifth graders (ONCY longs excepted), the other is a statistical conceit, and only relevant in the FDA context, as a means to establish the magical (although still a conceit) Stat sig.
You can have more than sufficient power from as few as 10 people if the effect being measured is large enough. Hell you may even know this much. But ask yourself this after you get done rationalizing your long bias. Why doesn't Brad just tell you what the medians are? So what if they are not stat sig. Just say whatthephuck they are. Do you have a rationalization for his failure to do so??? Are you happy about not knowing? Do you think responsible researchers would provide the info.
Basking in the comfort of an HR and the ludicrous stat sig is myopic. Tell me Stephen what exactly is being measuring? Beatingtheshit out of data to provide acceptable HRs and stat sig result s won't fool the FDA.
Oh and tumor response--when you get the numbers on actual shrinkage and not zero growth (which is meaningless) call me but I won't be holding my breath.
Additionally results are affected in at least two ways based solely on the structure of the trial.and have nothing to do with efficacy (or in REO's case the lack thereof) and they are this 1) the length of time between scans or follow up visits and 2) the convention used to determine the time of progression or death.
It seems they are on a six weeks scan cycle (not 100% certain that this true and even if that is the goal, it rarely happens that scans occur exactly on a six week schedule, SD never shows me (or real researchers) anything. If the tumor shrinks that is newsworthy--but you ain't getting that data. They could only establish a statistical trend even when using the zero growth std.-absolutely worthless. So all this garbage about neoadjuvant is pure fantasy. OK a 6 week cycle-
But to analyze the data we need to know what convention they are using for measuring progression or death when the actual date is unknown. The most conservative convention is to assume they are dead or progressed on the date they were last seen but it is equally acceptable (but less responsible) to assume they progressed on the date they were seen to have progressed or did not show up for a scan, the middle ground assumes the midpoint. In trials with very short OS's like this one, the difference in the medians is meaningfully affected simply by the convention they use. What we do know is this - they censored patients on the day on which they received additional therapy ( BTW a first in the history of medical research.) if they are using the date on which pts are observed to have progressed and ensoring pts on the date they get other better therapy, it will tend to understate the date of progression relative to those who are seen on a 6 week schedule, on average by about 3 weeks. Once again skewing the data in favor of ONCY.
D2 I read his stuff. Nothing new. HR stat sig blah blah. Stat sig of what??? The data has been so trampled on that you can draw no conclusions whatsoever. Go back in your mind to the very beginning and look at what the trial has become. It is the worst run trial in the history of medical research. They censored 50 patients !!!!! This is unheard of. They had to split the trial because they did not even know that mets only patients "live a long time" Bogner's assertion that the MOA is well understood is simply wrong. Matt had no idea why REO should work better in mets. Now that it seems that they live longer simply because they live longer maybe the old MOA is back on the table.
They data as presented raises more questions than it answers. What is the median OS is a simple uncomplicated question yet they refuse to answer it. The statement that the sample size it too small is simply a lie. They were going to give you median OS data on REO 015 where n=16 (of course they NEVER did give you the data)
167 patients and no median OS. ludicrous. As for censoring, trials lose patients all the time but never 50 or so. IMUC lost 7 in a similar size trial, moreover, "normal" censoring occurs when patients are lost to follow up But ONCY knew the patients were NOT dead yet they censored them anyway. It insults the intelligence of everyone except the donkey ONCY crowd and by itself makes the data useless. Throw in measuring the OS data (without of course telling you what the actual numbers are) from the median PFS! #$%$ is that??? Nowhere in the world where people eat with utensils do you measure OS from the median PFS. It's absurd and meaningless. You measure it from DAY 1 and its a simple observation needing no math whatsoever to determine it.
So blathering on about HR and stat sig misses the entire point which is this-- the data on which it's based is pure garbage and the pregnant question is why. Once you answer that you'll have all you need to know
I speak nothing but the truth and if you had been paying attention you would have to admit that. I have called it all correctly. The p3 failed and failed miserably. In fact it is very likely that those in the control arm did better than those on REO if you counted all the patients.
Did you fail to read the PR on their failed P3??? The real question is why is still over a buck