I believe the silence regarding the reason why the DCVax-L Phase III trial has been temporarily halted for additional patient screening is about to break, as the company has decided to end enrolment and complete the trial pending the accumulations of the targeted 248 events.
As a result, it may have no reason to keep the general public in darkness in regards to the reason of the halt, as it will no longer compromise the trial because it is ending anyway.
As many of you have been aware of my theory for the halt, but for those who have not been aware of, let me just simply say the reason for the half may be due to the two main factors, 1) the low event rate, suggesting efficacy of the vaccine; and 2) the identification of biomarkers which correlate with long-tail survivals of a significant patient population, accounting for about 30 ~ 40% of the total patient population.
As a result, the FDA and its equivalent in UK, Germany and Canada have placed the partial halt for screening, because the authorities would not want to subject the vaccine to the potential placebo patients if screened and randomized, and would also not want to subject the vaccine to some potentially not reactive patient population, such as the proneural gbm patients. The authorities want to the trial to continue as it is, and want to the answer from the trial data. Fortunately, today we are very close to that.
In the meanwhile, the company would not want the reason to be known since that would compromise the trial because patients in the trial would demand to know whether they have been actually receiving DCVax-L or just placebo. It also doesn't want to compromise its ongoing dialogue/discussions with the authorities.
So the saga has been ongoing for one and one half years, and finally it is about to end!
When the reason becomes public knowledge when the 248 events are reached and the company announces it along with the reason for the halt, the only shackles that have prohibited Neil Woodford from buying of additional nwbo stock in open market will also be shattered, although I don't care much about his buying or not and he has done more damage to the company and its shareholders than that of the whole wolfpack combined.
On a related issue, the current financing was expected but honestly it was a bit of surprise to me in terms of its not favorable term considering the moderate market reaction we have seen recently until the share price which was peaked in and around 14 December crates in and around the time when SEC requested information from the company and it is made known in the financing prospectus.
With that piece of information known, it is easy to understand why the company could not secure the financing in a much better term, and I would guess the company initially had a much better deal on hand, but could only see that deal aborted due to the so-called SEC inquiry.
In summary, I am not happy with the term of the recent financing deal, but I have realized that may be the best deal the company could have secured under that specific circumstance.
After the deal is announced, I have reviewed my investment thesis once again, and I have found nothing "untoward" and instead my confidence has grown even more thanks to LL's recent presentation and her subsequent email response to the inquiry of an investor. It is simply, if the target 248 events had indeed not been reached in November or have not been achieved as of today, I believe we will have a very good odds to see a very successful DCVax-L trial.
So I could not help but have bought more shares and I am going to see how things turn out in the near future when the trial data are known.
This is my only post for today. Good luck to all!
