I think the reason that passage about Covid still impacting the entire process relates to and has delayed several different matters including:
Obtaining clarification on something related to the trial and/or to the trial data.
Despite data lock, the steps (outlined in the PR) by which management moves forward with the data and its release may take the path, at times, of taking two steps forward and one step back. When and if that is the case, it would be difficult to update the shareholders as to where they are in the process outlined in the PR. And when clarification on something pertaining to the data is required, or something is identified that requires being addressed, obtaining clarification may involve contacting the authors, the PIs, the SAB and steering committee, the statisticians, possibly at times even the trial sites, etc. So if Covid is affecting any one of of those that might be involved in making a decision on something, or clarifying an issue, this process is inevitably slowed down. There are, of course, some regions and states in the US, as well as areas in the UK and the EU (where “the waves of COVID-19 cases” are especially), where Covid has jammed up so much, and so that passage in the Q is likely meant to remind and explain how so many things that could already take some amount of reasonable amount of time to wrap up, might take double or triple the time.
There is also the additional data that this trial is accessing that involves a deeper dive into some of the other GBM trials’ external control arms that may have, at times, required additional information that might require the assistance of specialists who have also been impacted, at times, by Covid.
That same passage also states that there has been a reduction in compassionate use cases due to Covid-related travel restrictions.
I believe there are, at times, restrictions as to how far one can drive in the UK from their home, and if the patient can’t reach the area in London where they are currently able to administer DCVax, then the patient unfortunately misses out on that treatment.
Another area where Covid would have impacted the build up of Sawston as well as the certification process with the regulators.
Readying Sawston for inspection likely involved the hiring and work of many specialized professionals, some of who might have been unavailable, or unable to work at times for reasons related to Covid. I think that is also severely slowed down the build-up there at Sawston.
Covid has ground so many things to a halt, so it’s entirely understandable that it has tangled and tied up the process of getting the DCVax data and manufacturing along the pathway that’s been established for getting it ultimately to approval.
Seeing as you work with neurosurgeons and neurologists on an everyday basis, this explanation might make sense to you. It's likely that it involves the publication at times (as hopefully explained in the first paragraph), but doesn't imply (IMO) that the journal process, at this time, wouldn't involve having submitted a first draft of the article yet. As to experience and lack of urgency, I'd disagree as first, everyone has a lack of experience on dealing with the slow down all things Covid, and I'm sure the NWBO management team is fully attuned to the lack of urgency of moving DCVax as quickly (but thoroughly) though the process as possible.
AI
