Some speculation---and I stress speculation---on the SAP.
In my experience as a regulatory attorney(involving the FCC, not the FDA), it appears that regulatory agencies have their own agendas and in reviewing and rendering decisions desire broad leeway without committing or seeming to commit to those whom they regulate. Perhaps nothing new here and even obvious to all.
Accordingly, it is my speculation that the RAs are not going to "bless" or otherwise give any assent or even guidance wrt the SAP submitted to them by NWBO. I believe that the RAs, after a rather cursory review, will essentially and simply tell NWBO...."Let's see what you got and what the data shows." I don't believe they will go much beyond that.
Accordingly, I don't believe that RA "blessings" or "comments" on the SAP submitted will be a significant pacing item. I am reasonably certain that with their many contacts with the RAs, NWBO knows the regulatory game pretty well by now. They pretty much "know" that the foregoing reaction is most likely. They may still not have submitted the SAP to the RAs by now and are using silence and even innuendo that it is the RAs who are "dragging" their feet, not NWBO, giving NWBO an excuse and even more time to delay TLD in the name of dragging the trial out further.
Just a thought and a concern that TLD may not be announced in 2019. Are they pointing to ASCO 2020? What happens to the warrants? Do they expire "just like that"? Kind of scary and not such a bizarre thought after all. The games frustrated minds can play!! JMHS(peculation).
