Let’s clear up some misconceptions. TWO seems to be key for some here.... It seems that people have some weird ideas and it’s not clear to me or others that don’t have the same misconceptions until someone says something. You can think I’m wrong but you’ll have to prove it.
ONE: 578 “events” mean 578 deaths.
TWO: If someone dies after the 21 month, it does not add to the “Event” total. The data may be used but it’s not with the 21 month statistic as the primary goal.
THREE. This all means after the first 387 events, they need to enroll the remaining group to reach the 578 events WITHIN the 21 month period.
FOUR: Secondary goal should be complete so they can potentially report on it since it affects comet-2.
FIVE: The Prednisone standard that I looked up was HR: 0.63 at 20.5 months. That is what the FDA need them to beat to show significance. Thus if 99% of the patients were enrolled by june 2013, we still need to wait until March 2015 for the 21 months for the trial. If they reach 578 events by then, it’s likely the trial has failed.
If you disagree, tell me why so we can understand the specific points. If you think I’m wrong just because I accidently type 2014 instead of 2013, then you should probably give your money to your mommy instead of investing.
Assuming that it was mostly enrolled by June 2013, that would still put it March 2015.
FIRST:After the 21 months, the patients are done. If they die off, it's not used in the same way. The data may be recorded but it's not officially part of the study. They may have all died but it does not count as the "EVENT". BIG MISTAKE.
Also, the interim appears to have been designed to signal a go or no go. i.e a partial study that would not meet the FDA requirements. This is common to save money on a product that will clearly fail. Then they enrolled the remainder to finish the trial. Sometimes they get lucky with an overwhelming signal or unlucky with an underwhelming signal.
I intended to say thrid quarter of 2013. It's 2014 and I have to write the date a lot so it's habit. I admit it so get over it.
Thanks for pointing out sept 2013... Now count to 21 months. It does not come to March 2014.
I may type the wrong year out of habit but I can count 21 months.
I'd like people to quit being ignorant. I got the distinct impression that people didn't realize that "event" meant death. Say they had 387 patients completed at interim. They hoped for a clear sign of go or no go. They either go a dubious result or a go result.
So they have to finish the trial. They could have enrolled the last third of the study the third quarter of 2013 which mean they won’t be complete until the middle of 2015 with the 21 month trial period. Simply assuming that enrollment was continuous or mostly up front to get the 578 “event”s to finish the trial for significance is wrong. No other way to put it. Wrong.
Thus, to say the data is “late” is wrong. Yes, they said by March 2014 originally and they did report on interim. They were hoping for an early end but they didn’t get it so the trial continues. Assumptions lead to misconceptions.
Remember that you’re lensing information through the CEO and people who have confidentiality agreements in place to keep specifics quiet.
Thumb me down all you want. It won’t make you right. You’re still wrong.
It’s truly unfortunate that the majority of the population is average and below intelligence.
The secondary goal is finished; thus, they have something to report on comet-1 and I don't deny that.
If they need 578 events to satisfy the FDA and don't beat prednisone for the 20.5 month with HR 0.63, then it is no better than prednisone. If they finish too far ahead of the 21 month after final enrollment, it's bad for us. If they finish well after the 21 month, then it's good.
The issue is that I doubt anyone knows how enrollment went. They set up an interim analysis for ~387 even. Now the question is, did they continue recruiting as heavily? Did it fall off? I don't know, they could have enrolled the last 1/3 of patients in the third quarter of 2014, which means we will not have the data.
Unless someone can step up and tell us what the exact enrollment was each month, no one can possibly predict the final data. However, it should be not be too long after june 2015 if we have not heard anything. The longer the better.
Everyone here has beliefs and hates me but they're beliefs are back by nothing. We can expect to wait. There is no reason to actually believe the data is "late"? No one can determine that.
It is literally on the same level as "when is Roche going to buy Exel". No one knows for sure. No point in believing it's true until more solid information comes our way.
I'll just go over to enamresu's posts. At least the parroting is entertaining unlike this flat-out wrong misinformation..
As I've been trying to tell others... The trial will end if they reach enough events. Everyone seems to agree with that but the problem is "event" means death. If they reach the "event" limit to end the trial, it failed. Otherwise, to meet the primary goal of 21 after "start", they have to carry out 21 months past last enrollment.
The metric for Prednisone is 20.5 months with an HR of 0.63. I don't know what the distribution of patients is but 578 deaths would bring it within the lower 95% of the current treatment which means cabo is less or equally effective than the Prednisone. If it's equal, it has to lead to better quality of life than Prednisone.
The sooner we the data, the worse it is. We could get the data before June 2105 if all the study fails or the remaining patients die but do not bring the HR too low in which case, later would be better.
I hope we do not get news before June because the sooner we get it, the more right the shorts are.
Let me tell you what’s likely to happen. You’ll see a run up of price and block buys leading up to the 21 month after final enrollment. Then there will likely be a sell off to take profits before the announcement (good or bad) for hedging purposes dropping the price. Good news, we’re good. Bad news we’re not so good.
You do understand that if they reached the "event" end rather than the trail end, they failed significance? It's better they trail ends at the end of the 21 month period after last enrollment because that meant they're not all dead before the end.
It would be much much better for our investment if it did.
And would that have been the prednisone arm or the cabo arm or both? How many were enrolled in each?
Where is the link to your certainty? What was the enrollment rate after 3/25?
I'll clue you all in. The HR at 20.5 months prednisone is 0.63. Thus at the lower bound 95% of prednisone or 578 events (i.e. deaths) signal statistical insignificance is nullified and comet-1 fails.
Now tell me. If you get data before June 2015, did the trial fail or potentially succeed? It's clear that you or any parrot on this board does not understand what "event" means.
The HR for enzalutamide is 0.63. If EXEL beats enzalutamide with 960 patients, the study will not reach 578 events.
GET IT? PROBABLY NOT......
I'll add to that. I hope that we have to wait until June 2015 because that means that last enrollment lived 21 months to end the study.
If you want the data sooner, you're hoping they die and you're shorting this stock.
All of you are barfing up the same #$%$ and you still don't have the data. It's clear that you've failed to understand the details. You take the advice of people that you determine "know better" but don't. Clearly you're all wrong. The proof is in the pudding. According to all of you, it should have been done in Jan 2014. But where is the data? You and all your "friends" are wrong. PERIOD... It has been proven. You do not understand. PERIOD.
You have to wait. At best, we'll get bone data as that should be done as a secondary goal of comet-1.
The median OS was 18.4 months with enzalutamide, genius. How do you get it with 6 months of data?
You need to take it past the enalutamide standard.
I meant final enrollment was sept 2013, counting 21 months makes the final date june 2015. The trial does not begin for the last enrollment until they enroll. Thus, if you can count, it would be clear.