Why do you communicate with armed lunatic as if he were human. You ain't gonna change anything this clown "thinks". He is only good as a chew toy for his intellectual superiors. Putting him on equal footing only diminishes you.
I took some liberties. I agree that The FDA will not go to .05 once there has been an interim look- especially where the end point is PFS. But as you note and other posters seem not to understand, the company can choose to skip the second, and for that matter the third interim analysis to preserve Alpha. That is a risk that most posters have not factored into their thinking. IF they do announce that they are skipping the next interim speculators should be very scared.
Ah d2. So sad about ONCY. I'm serious. Anyway, the PEI doesn't know any more than anyone else at this point. And yes it is a very big positive that it has been approved, although I don't the terms of the approval. I seem to recall that it is premised on follow up data and not permanent but whatever.
What we do know is that the trial was not stopped for efficacy after 66 events which should temper expectations in those with any sense at all. And we know that they haven't announced the 88th event. You more than most should know what delay means-- and it is NEVER good. I make no prediction other than to note that I doubt the delay is related a massive increase in OS especially in light of the interim at 66 events. More likely it is that enrollment velocity is not meeting the company's projection, which isn't terrible news but obviously isn't good news either.
My only point is this - It's all risk reward. A few other posters don't seem to get it. If you are on the sidelines, you won't miss out on a 10 bagger, you will have plenty of time to get in a modestly higher prices. On the other hand, as you learned in ONCY- once money is lost it ain't coming back. And then you will miss every 10 bagger for the rest of your life. Living to play another day is the name of the game.
I recall our colloquy. Nevertheless, the model is as likely to be wrong on enrollment velocity assumptions as it is on prolonging OS past 18 mos.. Furthermore, my lingering concern is that since it is within the company's discretion to skip one or both of the remaining interim looks - (see e.g. the Oncolytics p3 fiasco) they are going to do just that and let the chips fall where they may. Remember that each interim look uses up some Alpha spend. If they don't do the interims they may be able to convince the FDA to up the stat sig p value of this trial back to the traditional .05 instead of the current .02. The .02 is probably premised, in large part, on the fact that they projected three interim looks. I still expect them to take a look at 110. But if they skip the look at 88 it won't be a positive development.
There is more risk that reward right now. You already know the results are not stellar because the trial was not stopped after 66 events and you will not be getting ANY efficacy data from that look. It is also very unlikely that it will be stopped after 88 based on the results of the first 66, so even if the news is good you will have plenty of time to get in at reasonable prices. Why risk it here?
The 800 pound gorilla well 2 800 lb gorillas in the room are the the lack of any announcement of the second interim analysis, which was to take place at 88 events. 66 event threshold was announced in early Dec 2013. In a week it will be 7 months. Be prepared for another announcement pushing back the completion date for full enrollment. In addition the lack of efficacy data is a bit dismaying and reason for some concern.
The 400lb gorilla is the next round of dilution which will be coming very soon. Company is burning cash at between 5 and 6 mm a month giving NWBO only about 60 days of cash. The stock is almost certain to tank on the news of the next round of dilution. The drips and drabs of revenue from Germany won't be enough to avoid the necessity of a capital raise.
You will get a better entry point in the next few months and there is no upside catalyst in the near future. Sidelines folks.
most of the get rich quick crowd has run off in search of other magic beans. The culls who still hold the stock are too ashamed to post.-- and a few have probably slit their wrists.
very sad. Donkey's who refuse to reassess based on new info. Trapped in the hopeless fantasy that their lost money is coming back while one of the greatest bull markets in history passes them by. HEEEEEEEEEE_HAAAAAAWWWW.
The greater the measured effect - the smaller the number of patients needed to establish stat sig. Increasing the size of the trial is, generally speaking, not a good sign, although it is certainly not a death knell. This much is very clear. If there was a doubling of median OS, 110 would be way more than enough to yield a p value less than.05.
As for sub group analysis-- that is the Miss Congeniality award in the clinical trial world.
This is all you need to know.
However, the median PFS times for control and treated patients were 8.5 and 24.1 months, respectively, indicating about a 15.6-month or 184% statistically significant PFS increase for treated patients (HR=0.259, log-rank p-value=0.005).
A sad sad case. Mentally ill. I truly feel sorry for him
Unmethylated HLA-A2 patients, differences in PFS are huge 24 mos vs 8. Unable to even calculate median OS yet because too many still surviving. Methylated HLA-A2 OS increase of about 4 months. This is clinically significant and with a sufficiently powered p3 will likely result in approval.
How did you calculate your silly figures? IN the end all that matters is separation between the OS curves. And right now there is a two or three month separation which is likely to get somewhat larger as the data matures.
Duuuuude you have been given "solid info" buy ONCY and her it is--wait for it---THE P3 TRIAL FAILED--REO DOES NOT WORK. Confusing patience with ignorance is the sign od , dare I say it? - A moron.
That is kinda stupid. It is very unlikely that people would fail to progress but once they do they die faster. If PFS improves it it is almost certain to push OS out at least as much.
Duuude. You are kinda clueless. PFS wont move at all because all the data is in Apparently you didnt know this but it's a fact. Additionally median OS is unlikely to move much more to the right on the curve for reason to complex for you to understand. BUT, and this is yet another point you fail to understand,OS is important but reasonably well know and thus it is the P value that matters most at this point. Even if the OS remains at 2 mos, the p value will almost certainly get smaller. A 2 month improvement in OS with a statsig result would most likely result in approval down the road. (This will not happen because the trial is not powered to yield a statsig result with 124 patients But Temozolomide was approved with worse OS results. The stock would likely move to 3 or more simply by acheiving statsig without any improvement in OS. If you think OS is going to be 6 months, or more than 9 mos you are smoking crack. It is statistically impossible at this point. And if it improves OS by a statsig 4 mos (not likely) the stock will go to at least 7 in a matter of weeks and probably higher.