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Well yes, it's a convertible debt. It still holds a 12% interest rate and it is backed-up by assets (the UK property), warrants wouldn't have had nothing to do IMO with a similar transaction.
Today's transaction is quite good and anyhow, better than most expected.
First of all, it is much better than the very last transaction, which diluted shareholders much more in comparison. Indeed, while the principal amount is of 6M (including an OID of approx 9%), the convertible debt has 3 year maturity, no interest payment during the maturity period, and while it holds quite a high interest rate (12%...considering that it's also backed-up by the UK property), it has a reasonable conversion rate.
Considering a non-composed interest and a potential conversion right before maturity, the conversion of 8,160M would be as follows:
4,080M for 16,32M shares;
2,040M for 4,080M shares;
2,040M for 2,040M shares.
All in all around 22,5M shares: a quite good transaction.
around 90% received the vax at some point.
Very quickly. This is from clinicaltrials.gov:
Primary Outcome Measures:
The primary objective of this study is to compare progression free survival from time of randomization between patients treated with DCVax-L and control patients. [ Time Frame: Time to tumor progression or death ]
Secondary Outcome Measures:
The secondary objective is to compare overall survival and time to disease progression between DCVax-L treated and control patients. [ Time Frame: Until Death ]
As I commented in an earlier post, it talks about control patients. Now, again, as I said earlier, IMO this is why they chose PFS as a primary and OS as a secondary. IMO the OS would have not been feasable with a crossover arm as a primary endpoint, therefore PFS as primary and OS as secondary. As BioInfo pointed out, it is possible that they might also consider statistics for a third arm.
The fact that everyone is living longer can be interpreted in many ways.
If anyone seems to be living longer included those in the placebo arm, it might be for the inclusion criteria. If anyone is living longer because they progress later and that happens in both arms, obviously it is good for patients, but IMO it might affect study's results.
If anyone seems to be living longer but that is due to the fact that a high percentage of patients, either in the vaccine or in the control arm, received the vax, then it's all a different story.
However anything could be, and that is part of the uncertainty.
Yes, IMO you get compelete dataset for PFS.
This is why I believe the PIII trial has PFS and not OS as a primary endpoint, which IMO was a choice due to the presence of the crossover arm. When the trial was designed they didn't think (IMO) that it would have lasted this long, so they designed it and accepted the crossover arm and that pushed the need to choose PFS as a primary, instead of OS. The fact that they observed a long tail was IMO unexpected and they did prefer to gather all of the possible info in order to try to push it to some for of approval, just in case PFS would eventually fail. This is all IMO obviously.
Again, I agree on this, too. You make valid points.
I agree. That's why IMO they had PFS this time as a primary endpoint and not OS, which would have been in my opinion better fit without crossover.This way you can have a clean stat on PFS, since you crossover after progression, while keeping the benefit of the vax in consideration of OS as a secondary endpoint.
Interesting timing.
Long article to confirm that I am right, didn't need that, but ok.
If a company files for Ch. 11, most of the times shareholders get wiped out.
Sorry but I don't see anything in the info you provided that supports the fact that the control patients that will be compared with those treated will include those ones who crossed-over (I refer to OS obviously, for PFS it is self-explaining, as they will get treatment after they progress).
Where did you get that information/idea?
The trial lists:
Primary Outcome Measures:
The primary objective of this study is to compare progression free survival from time of randomization between patients treated with DCVax-L and control patients. [ Time Frame: Time to tumor progression or death ]
Secondary Outcome Measures:
The secondary objective is to compare overall survival and time to disease progression between DCVax-L treated and control patients. [ Time Frame: Until Death ]
While there's no hurdle in the primary endpoint as it measures PFS and you can have good statistics on that, I believe there will be hurdles on OS, unless (and thus the choice for OS as secondary endpoint) the study will give extraordinary results for OS as a whole compared to SOC.
Othernot I wouldn't understand as the "everyone is living longer", which is great for patients, might not be that great for the study.
Not true at all IMO.
I don't want to think anything, I just rely, as anyone should do, on company's PRs!
I do not to think anything, I am relying on company's PRs, and you should, too.
Statistical analysis is obviously done after data lock, therefore willing or not, final results won't come right away after data lock.
Why the statistical hurdle or why chances of some kind of FDA approval?
IMO right concern. The trial results will compare the two arms, no matter what. There's IMO a high probability of a overall good result on OS, but the statistical part will be a tough one. In my opinion, even if the trial would "statistically" fail, at this point it should somehow find a path toward some sort of FDA approval.
I totally disagree on this hypothesis.
If you think noone discussed the pace of enrollment then you must have seen the wrong board.
Then I believe I am right that PFS might fall somehow shorter than many expected.
Again, while I look at page 12 with the recruitment graph, I ask myself: where is the 25%+ long tail?
Actually the more I look into the recruitment slide, the more I personally get the feeling PFS will fail. I am a bit more optimistic about OS, but.
Yeah right, 400K OS shares, very very low. LOL. Ok, next.
A RSS doesn't require shareholders' approval.
Usually they have a set price of 0.01, so that they are considered prepaid even though you have to put a penny up to exercise each of them.
Patient? If OS events will be reached in July and from then on the co. will need a couple of months for statistical analisys, I wouldn't even want to think on how many more shares might be issued before final results.
Naked shorting? lol
I believe market cap is killed by outstanding shares, not the market you decide to be listed on.
You are wrong as the presentation already estimated when those 233 will be reached, you might want to watch it again.
"I think you will find it interesting when that publication comes out". I liked this comment a lot!
The IP world is not that easy. This is from the last 10K:
"We have recently also been exposed to claims (without a lawsuit) by a competitor asserting or implying (and commentaries by third parties based on the claims by our competitor) that a patent issued to our competitor covers our products. We believe these claims to be without merit. However, if a lawsuit for infringement were brought against us, there can be no assurance that a judge or jury would agree with our position, and in any event such litigation would be expensive and time consuming. In the future, we may again be exposed to claims by third parties - with or without merit - that our products infringe their intellectual property rights."