it's common for phIII results not to mirror PhII results. If it wasn't, than why do a PhIII? It is where drugs go to die, always has been.
I read it as this:
Systematic means that the only way we screwed up is if all of your coded variables tx vs. non-tx were reversed. Otherwise, Galena, your drug did worse than placebo. You need to stop the study. On the incredibly, holy#$%$-how-could-anyone-be-so-stupid remote chance that all 140 of your testing sites reversed the codes in the spreadsheets you gave us, resubmit. But do it fast, as this doesn't give you the right to dither, it's just a way for us to cover our #$%$. If that's not what happened you need to stop the study asap.
James. Everyone here understands you are comin from a place of true darkness right now. I feel for you. Like you, I had a lot of hope for bc patients that this would work out, and lost a lot of money. You're starting to sound like a anti vaccine crazy person who still insists that vaccines cause autism. They don't. Neuvax failed. It happens. You're better off using your energy on treatments that maybe still show efficacy. I know for a fact that I'm not alone in thinking you're comments are sounding more and more depressed. You are in denial. That's ok, but you need to speak with your family about getting some help and good therapy. I'm not joking, I'm just trying to help.
It is mind boggling how many of you don't understand what it means for a trial to be blinded.
Galena has not looked at the data. If they have, that's grounds for terminating the study for violating a CORE PRINCIPLE of the scientific method.
Unreal that you would even say this.
I would like for them to time it about an hour after a PR stating the the legal issues are a non-factor. Usually after one good news piece, there is an uptick followed by shorting within the hour. A second PR right after shorts take advantage of the pop/correction (to prevent the correction) would be crippling and might trigger the squeeze we have been waiting for.
I am of the opinion that no news is good news here.
Tell you what, if there's a readout, I'll stop posting. If there isn't, you stop posting. Deal?
And I'm long, by the way. I don't know why stating facts is "subtle bashing" but it's clear that you would rather ignore facts than debate reasonably.
Statistics. They are entirely different statistical equations. Even if the IDMC were to assess for efficacy, which they won't, they are legally obliged not to reveal the statistics to anyone. If they did, which they won't, and it leaked somehow, that would be horrible - here's why - It's unlikely that, at this point, we would hit our primary endpoints. It's likely, however, that we would show a trend towards efficacy. But just by looking, that would cost statistical alpha, require a correction, and thus you would need to meet a higher level of significance at your next read. It's best not to look early for this reason. I believe this is why Bijan has stressed so much that this is not an efficacy read, as he wants people who understand stats to know that they are not spending alpha at this readout.
A. Pop up a lot on good news but then get taken back down in anticipation of the 3 and a half plus years it will take to get to a new drug app.
B. Pop up a little then back down because of cash burn issues? We have enough cash for 2 plus years before they need to raise.
C. Start a 3 year run into a buyout / partnership and never look back. The best for us longs...
D. A little blip and the same old market manipulation for another 2 years.
E. Fill in the Blank with your thoughts.
E. Pop up a modest amount (to around 3-3.50 by early July, and then manipulated down to around 2.50 until next offering in late July,which will be between 15-40 million shares, then down to 2s unless another catalyst occurs. Will trade in 2-3 range until next data peek which is for efficacy and not just futility, and then either crash into bankruptcy or rocket to double digits.
slow and steady wins the race. We are building a ton of support at 2 bucks now. This will be a good foundation before a run up.
From the Q4 conference call - Dr. Bijan Nejadnik
Bijan, 4Q2015 Conference Call:
"It is important to note that the study is double-blind, which means the physicians, the study staff, the company, the patients and all people working on the trial are unaware of whether a patient is receiving is NeuVax or placebo. The EAC is also blinded to the treatment of site. The IDMC is the only committee that will receive information on each patient's treatment assignment...Let me remind you this is not an efficacy analysis, once the 70 qualifying events are confirmed by the EAC the clinical data is compiled and submitted to the IDMC. The IDMC then needs to evaluate the data package for safety and futility. To reiterate what marks there earlier, regardless of the timing of the 70th event, we expect the IDMC review to be completed and the result of interim analysis to be announced by the end of June."
Actually, I believe you are wrong on the second point. The analysis by IDMC in this case is for futility, not for efficacy. Bijan has reminded, reiterated, and restated this several times. They are totally different statistical equations, one by which the goal is to determine whether the drug is unlikely to beat the control, based on specified "likelihood" estimation, in this case, 20% likelihood of eventually reaching the qualified endpoints and/or surrogate endpoints. Again, the 20% is not a RRR endpoint itself, it's a likelihood of eventually reaching the endpoint by the end of the prespecified trial timeline. That is a very, very low bar for good reasons. Efficacy is an evaluation of whether the drug is already and significantly better than the control (RRR at the current time).
Thank you for this, though can you please clarify how they would know whether it shows superiority on any or all of the PRESENT subgroups if there are no unblinded data provided to Galena? Obviously, if the recommendation is to halt for efficacy, they will clearly submit an NDA/BLA, but if not, how would they possibly get this information regarding efficacy without unblinding?