Hyperopia,
I agree with you, this is how it is today. I just don't believe that it's how it needs to be.
Here's a question for you, if all of the staff at all the regulators merely read the JAMA peer reviewed article and were asked to vote at that point, I believe the results would overwhelmingly say, approve the vaccine. Perhaps a Phase 4 requirement to track each new patient would be included, but such decisions could be made year before the regulator will act on million page documents.
I know it will never come to this, but how about if we cut it down to 10,000 pages, even 100,000 would be a huge improvement. There is an old saying that goes something like, if you can't impress them with the facts, dazzle them with tons of bullshit. I'm not saying that what we're providing is bullshit, but it's bullshit that the regulators require what they do.
If there is one thing that the information you supplied from the FDA does prove is that the FDA provides many opportunities to speak with them. So many here try to make us believe that what the company does is independent of advice from the regulators, but I believe they all provide about the same access, and smart companies take advantage of it. I believe that all along NWBO has been a smart company. Clearly the company doesn't have the staff needed to do most anything themselves, I believe the regulators have given them a great deal of guidance and may even suggested contractors who could be of assistance in certain places.
Once DCVax-L is approved and NWBO has increasing revenue each quarter, perhaps the company will decide to dramatically expand, and be able to take on more tasks in house. That isn't a sure thing by any means, certainly they'll grow some, but the intent may still be to stay small and contract out with specialists whenever it's needed.
In my career I was only involved in developing a publication once. I was in one of six govt. agencies ordered to create something new for the Navy, a Technical Repair Standard, it was to be done without specific funding out of our overhead. Of the eight, ours was the only one to develop a document that was acceptable to headquarters, and we were funded to produce more. It was roughly 400 pages, so a drop in the bucket compared to anything for the FDA, but it was still scrutinized by higher authorities who accepted it. I supervised the group, who also had never done anything like this, but in the end we had become good at what we were doing. I'm not saying I didn't write many reports, memos, etc. but none of that was comparable to publishing, this was.
Gary
AI
