I’m happy the Q is out and done. That being said I think we need to consider greatly the following; I’ve been discussing the publication aspect of the delay in getting out the TLD with some friends more in the research side of Medicine. They have confirmed my position that any and all of the top 3 or 4 Scientific Journals in the world are going to be directing the timeline of TLD release to some extent.
The data NWBO has collected is expansive and has implications way beyond GBM. If, during the time of data analysis the investigators and/or the company/SAB/Outside experts, etc. see much more useful data than even anticipated previously and add to this further expansion of DCVax-L indications such as rGBM and beyond then this could represent, to a Scientific Journal, the opportunity of a lifetime. I’d say to not underestimate the incredible power that could come from a top 3 Journal article, and if it’s really outstanding this may mean the cover story. Clinicians want to know when to switch treatment modalities and they look to a top Journal to guide this. That gives the Journal clout, and there could even be competing Journals vying to publish the DCVax data.
So, when you consider this you can see some possible scenarios of the timeline, while adding all the crap that’s slowing everything down right now due to COVID. We’re consistently hitting 4000 cases/day now in the US and it’s not seeming to dissipate. While deaths may be lesser per positive test hospitalizations are not. I’ve seen an increase over the last month in my ERs and it’s worse in other areas. This has a profound effect on all aspects of clinical practice (it’s directing almost all aspects of our large system’s clinical practices, and leaving little time for the normal things that need to be accomplished management and logistics wise), including those doing research. Relying on outside entities in this space must be having a continued impact maybe even with people working in the Journal space. So, I’m giving some wide berth here. However, I think the main point I’m going to make is this:
1. A major Journal is going to be directing what the company can and cannot say regarding TLD; they will absolutely require a full embargo of news put out by the Company if they’re doing a cover story.
2. A major Journal is going to require a partial or full embargo of news if they’re going to perceive DCVax as a stunning breakthrough treatment, even if not on the cover (I think their will be a cover story personally)
3. Even if a major Journal is simply agreeing to publish they’re going to want a partial embargo, like maybe a public TLD announcement with primary and secondary endpoint disclosure only and a remark that they have an agreement in hand for publication at such and such a date.
4. The more remarkable the data and the breakthrough the more quickly a major Journal will publish. NEJM published Pfizer’s work in 2 weeks of final data anlysis; so it can be quick, and I think once any major Journal has the data set, with it’s analysis, it will be very quick. I can assure you Pfizer had negotiated timing with NEJM way before the publication, and while data analysis was in progress.
All of these scenarios require a kind of delicate maneuver between the company and the Journal, with the Journal having the upper hand in some ways. And, remember the COVID issues; a top editor who has a sick family member? A top editor who also has duties to other issues? The company still waiting on some final analyses by SAB, some outside experts, etc. who also may be dealing with COVID or other responsibilities. Remember, while you’re anxious for results and while the company is anxious to get results out, those they’re relying on probably do not have that same urgency; they’re scientists, not shareholders. Their interest is in the science, not the business.
I believe we’re already in this last phase. I believe the data is almost ready and any delay is the delicacy of the play between a major Journal and the researchers trying to get the T’s crossed and the I’s dotted so that a major Journal will have what they need to splash the DCVax story to the world. I believe it as completely as I’ve ever believed anything. I’ve been wrong on stuff regarding this company in the past, but most was timeline related. So, I’m not going to make a remark about the whens, just the whats. And I guarantee this story will be told and told big.
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