In an email posted on v2 (now gone) Brad said the length of time for analysis would depend on "how complicated" the analysis was. I'm not sure what that means. The data (OS) on virtually all (150/167 or even more) patients should be fixed at this point. Is "complicated" a hint that he anticipates data mining subgroups/types will be necessary? Knowledgeable responses appreciated.
Tried 3x to post this onV2 (that epicenter of user unfriendliness) without success.
It's not complicated - how many are OS's? Brad is buying time IMO - data mining is to try and get some good news out of bad - same as more P2 PR's. This does not sound good but I will ride it to the end of P3.
Knogonads - Let me begin by saying I am a staunch defender of freedom of speech. People should be able to voice their opinions no matter how foolish. But that said, why would you want to keep repeating your conviction that the PIII will shortly fail, the stock lose 60-65% of its value but you are not shorting nor selling nor hedging your position. I'm trying to figure out what you're aiming for. If the failure happens and you lose 2/3ds of your current investment are you planning on saying,"you think I'm stupid for holding but I'm really smart because I called this?". ??? The word pyrrhic comes to mind.
I don't read BT's comments as the analysis will be more or less complicated. Like you, that is how I originally read it but that, but off course can't be the case. Now that they have almost all of the data, the just need to bin by treatment/control, determine the PFS and OS, and calculate the confidence interval. And, of course break out mets and local for these groups.
I think the complexity he is talking about comes from the range of answers they get. If there is no stat sig on anything, the announcement is fast: H&N is over. If the p is greater than 0.05 but good enough to get this with another trial, they would want to have a disscusion with the regulators, getting their agreement that this is worthy of pursuit in another trial. Although the could make this announcement without the FDA having commented, it would be better to say: this is good enough to proceed and the FDA agrees. If the The p is less than 0.05 and Europe say this is approvable based one trial, this would take more time because Europe would probably ask for data from the PII's before saying this.
The point is this: all of these scenarios might play out, and the amount of time to craft the appropriate response for whichever one presents itsself is quite variable.
I don't disagree, but I think some of the complexity goes beyond your scenarios as they mine data according to genetic responses by 3 subsets of the trial. All in an attempt to try to narrow the scope of the confirmatory trial and increase chances for success in context of reasonable sizing in the final confirmatory P3. I think they are getting better ideas on where responses are best as hinted at in remarks regarding the lung data to be discussed in a few weeks. I think this may mean KRas, but we won't know until we get the next pieces of the puzzle. I do not think the stock price is implying expectations of statsig, as the company has never indicated those expectations and the company has little credibility in the investment community anyways, and of course the share price is laughable. That's not to say there wouldn't still be a painful capitulation upon bad results, which I don't think are expected either. While the trial wasn't sized for statistical significance initially, the size did double and the new size for the overall trial could very well be enough to achieve statsig, or hopefully very close to it. The most promising subset is the smallest subset - mets, which is least likely to be big enough to achieve statsig. Hopefully the data will be good enough with impressive tail responses to encourage a final P3 at a reasonable size. I believe this is the path management would like to take this trial on, and it may be the least statistically conclusive. So mets results may require some more complex data analytics and then there's crafting a message that conveys the promising outcome and why the company chooses that path. Wherever they go with this next leg of P3, there's a good chance pending P2 findings will reinforce the likelihood of positive outcomes. If they get statsig in mets, that would be overwhelmingly positive. But let's don't confuse hope with expectations though.
Sentiment: Strong Buy
nome - thanks. Sounds right. One thing tho - I have thought all along that .05 from this trial was a very long shot given the n. And that a pivotal trial (hopefully modest in size and duration) was expected. I thought the company had been saying that. I'm somewhat surprised that the consensus now seems tobe we reach statsig here or bub-bye. And what about neo adj? Is that no longer anapproval path?
D2, the email is still on the V2 board (message #16968). Here is Brad's email to spdstr56:
"There is a time relationship to long term survivors that supersedes the event number.
The time from un blinding to announcement is highly variable based on how complicated it is!
We don't have to consult with the FDA prior to announcement. FYI our FDA reviewers are working from home, unpaid right now. A very dedicated group of people.
I don't take Brad's statement, "The time from un blinding to announcement is highly variable based on how complicated it is!", as a hint in any direction. They are blinded so they don't know how simple or complicated it will be. Brad just wants people to be aware that the length of time can vary.
It seems to me that all of Brad's comments over the past months have been cautious and designed to give "space" regardless of whether or not statsig is achieved in part 1. As CEO of a company in a important phase 3 double blinded trial I think he has to be cautious in his pronouncements. This is the time to wait for the data to speak.
noses. - I do and have always appreciated your civil, rational replies to my questions rather than kneejerk hostility of the mindless. It's the main reason I try to ask serious questions on the other board. But for some reason I can't post there from my ipad. Nor at times unscramble the convoluted way the "fixit" doctors have structured following threads there now.
I'm surprised so many now seem to be anticipating statsig from the trial about to be concluded. All along I expected the results would require a further pivotal trial and, if I'm not wrong, that has been the company's guidance. I do however think that the stats on 90% of our trial patients should at this point be fixed. All of them were stage IV and all have been on trial for 13 months. All but 10 or 11 in the treatment arm for 14 months. And very likely all but 4or 5 mets only treatment arm. The numbers for the control patients are extremely similar. Unless something truly bizarre is going on (historical norm 4.5 mo OS) those late stage patients who have had NO THERAPY whatsoever for nearly 8 months must have passed even if they responded unusually well to the carbotax before last March. Reo apparently does but carbotax AFAIK does not mediate a supercharged immune response.
I know some dislike my thinking about the known and unknown data but you have never been one of them.
When I look at that message with Google Chrome, I see the truncated message but there are also 3 little dots below it. Click on the dots and the message gets expanded. This may be what you're both (Probo and Fred) experiencing. Another Yahoo unadvertised feature.
Proboscises - in D2's defense when I go to message 16968 on the V2 board all I can see is the following verbage "I asked Brad a few questions last week and this was his response;" and can not see Brad's response. It is probably a browser issue with a special character or some such thing. Nothing nefarious I'm sure.