Hi Bio,
First, saying it again: I appreciate you, and thank you for your thoughtful contributions.
Second, I thought the same re the timeline on finalizing these regulations & guidelines, expecting it would be sooner, definitely thinking by 2021 year’s end … tho with less basis for my opinion than yours :)
In my experience, but not FDA-related, I’m a bit familiar with the agency rulemaking process, federal register publication, comment submission periods, etc, preceding finalizing revised regulations. So I guess the surprise here for the wait, as I’ve not seen anything like this long process.
Sorta analogously, but from experience, I do understand how strong the BP lobby is, not that I’m inferring anything here. There was a period in my career when I, together with a number of my contemporaries/colleagues from different corporations, were meeting with members of Congress, on both sides of the House, re a particularly significant legislative reformation effort. We were a fairly high level corporate delegation. It was surprising and eye opening as well.
This legislative effort had bipartisan support on the House of Reps side, but when discussions with Senators and their Legistative Directors (LD) then ensued, it became apparent the legislative reform supported by corporate America writ large, would die. Why, one can really never know, but during a subsequent, and private conversation I had with a key senator’s LD, I sorta clearly sensed that if BP didn’t support legislative reform here on the Senate side, it was doomed; and it died. One of my colleagues (and former clients) was head of a big corp organization, similar to mine, different industry. He was there at these meetings and we had many shared corporate interests, but not all apparently. He subsequently became the executive Director of PhRMA. Looking back, for me, the bottom line is BP is (to me) incomprehensibly powerful and not to be taken lightly.
Through that experience and subsequent investments, a lot can fit in about why NWBO management may be proceeding with cards closely held. I have a sense of the power & capabilities of BP. Any sophisticated David, versus a Goliath, would be foolish not to tread very carefully. There could be many answers re what’s going on within NEBO and this excruciating “quiet period”, but I’d never discount the fact that there are big powerful forces working to blunt NWBO’s objective and possibly provide a rationale for what we’re watching on the sidelines.
Cap
