Hi Nick,
I've said a few times that I think the FDA is signaling with those articles that they know they are behind, and there is some hang-up with the final guidance, but that that is their policy for now. So I think any journal or others would need to take note of those articles and signals, particularly given how high-up that last article signals there is support for the new policy and in regards to oncology.
So I presume that if there is a hang-up, it is again, simply someone likely trying to make sure that whatever they sign-off on, it fits the requirements of what is anticipated to be that policy. And the policy does have certain requirements that I've also opined on with regard to how I view Roger Stupp's likely contribution. I do not think he has seen the DCVax results nor do I think he would be opining on them, but rather that he would be a blind reviewer and advisor on the creation of the synthetic placebo, ensuring that it is not made to fit the circumstances but is reflective of what such a placebo arm should look like absent any influence from anyone with a bias.
So I have my opinions. I think it seems like all the pieces are there and they are likely working very, very hard to get this over the last humps. But there are likely very careful, curmudgeonly reviewers who are making sure theirs and their journal's reputation are safe with whatever they publish.
I do not necessarily think, therefore, that they are awaiting the final publication of guidance, but I think the looser circumstances can lead to a lot more care and effort on the placebo arm related details. And in fact, some of the detail they may have been "waiting on" that has been signaled as being delayed by the pandemic, may in fact have to do with OTHER trials, other data, other details that were not in the DCVax trial. Or they may have some additional new real world data they want to include, based on things the FDA has advanced. But I think that is doubtful and that any data gathering or delay would be with regard to ensuring that the placebo arm is representative, completely blinded and complete.
All just IMHO.
Thanks for the kind wishes and I hope you're well also!
