I think it’s time I said a few things because it’s become quite clear to me that people simply can’t comprehend how COVID is effecting things, and it’s a huge part of what’s happening with TLD/Publication.
At my institution we’ve been at war for almost 2 years. Working a shift in the ER now is nothing but inefficient “work arounds” that we have been forced to deal with. We are losing nurses by the droves because as they get sick of being abused by overwork, underpay, and complete lack of respect they become travel nurses often making up to 4-5 times more on the road. As that occurs we’re then forced to hire travel nurses from a shrinking pool of available candidates. So the administration, to save money, lay off the unit secretaries that make and take phone calls, the phlebotomists and radiology techs, and the lab technicians that we rely on to keep the flow going. And with COVID spiking again in our area we have no place to put the patients so we’re running mini ICUs in the ER all the while being unable to shut the door to stem the tide of patients. It’s unsafe, sometimes unethical, and always exhausting. We can’t get medications and even normal saline at times because of shipping delays. We are in constant crisis mode so much that it’s now just considered the standard routine.
Now, try having statisticians, a Scientific Advisory Board, outside consultants specializing in Regulatory Approvals and Journal Publications, Peer Reviewers and Editors from a major publication, 2 lead investigators on separate continents that are also still sought after and busy clinicians, and the management of NWBO who’re trying to hold this all together and keep people in focus while all these other people have other jobs, other responsibilities, families, lives outside of work, etc., DURING A PANDEMIC and who aren’t investors in the company. And they’re all trying to get this right because it will be the biggest news regarding the major scourge of human life in history.
I’m a bit familiar with the type of things that are most likely happening and I believe the following:
1. The publication wants to break this unprecedented news and capture the attention and prestige this will bring to them not to mention as scientists be a part of this ground breaking treatment. But they are undoubtedly requiring certain things to be clear and may even be asking for additional clarifications in the analyses. There may be one or two reviewers who’re wanting no stone unturned because their reputations could be tarnished if any controversial crack can be worked by critics.
2. I believe the SAB also has requirements and clarifications so that when they attach their names to this they are safe from negative criticisms if the minutiae that may not be needed for regulatory approval is able to be picked apart in any way. People in these roles are defensive and have egos, and they’re being paid to be that way to protect the company
3. As stated Drs. Liau and Ashkan are busy clinicians and in demand for other issues and anything that may be needed from them is also asking for additional work no matter how dedicated and motivated they are for this to be done. Think about the statistical analyses that were required to be reviewed, recalculated for accuracy, and vetted by Dr. Liau and Ashkan, the independent statisticians, consultants, the SAB, etc. for use as the comparator trials for SOC. Do you actually think she just grabbed the first 3 she came across and said “yeah, these look good, let’s just use these.”
Now, add in COVID; all of these people are susceptible to being sick, having family members being sick, having difficulty in the other work they have on their plate especially if they’re clinicians or academics during COVID. What about having access to MRIs that might need another review? What about tissue samples that need to be looked at again because a reviewer has a question about something they feel important? All of these things take a working and efficient infrastructure in other institutions and offices around the globe as well as shipping of items or documents. And, I believe there are ongoing dealings with regulators who themselves are under the same stresses and inefficiencies adding yet another layer to the 10 dimensional chess game that’s going on.
At my job we’re at 50% over capacity in patients and 50% understaffed. Everything we do is harder, takes longer, and takes fortitude to keep at it. Those who’re not involved in these types of things, whether it not having their own business, not being in health care/science, or any other endeavor who’s inner workings have not been thrown into turmoil cannot imagine how COVID has probably taken a toll on everyone involved in bringing DCVax-L to the finish line.
There is no bad news and I believe we’re not only close to TLD/publication but we’re going to have manufacturing not just in the clean rooms at Sawston but also a quick certification of FlaskWorks fairly early in the year. NWBO is going to get this precisely right because this is going to blow the lid off of the science universe. Mark my words, the PRs that will come out will be on the front page of The NY Times, Dr. Liau will be on every morning TV show and nightly news, the BBC will interview Dr. Ashkan, it will be the talk of social media, and NWBO will be plastered all over the financial media. This is not some run of the mill trial results and this is a tiny company who’s life and death depend on how this is brought to fruition. I believe the publication brought out much more than was bargained for and they simply could not afford to dismiss the opportunity despite this lengthy cost. As much as investors wish reality was the fantasy they imagine, it’s simply not. But the end will justify the means, and the hand wringing will give way to the elation everyone wants right now. Don’t sweat the wait, it’s illogical and sweating is succumbing to one’s emotion. The big payoffs always reward those with the courage to see beyond what makes the pussies give in right before the reward. This is not some new concept.
