Nonsense. This is 15 years of data, not just the first 2 most important endpoints. And yes, I believe there was interest by a journal who had declined the interim blinded data, which I wouldn’t blame them for frankly. I may have the timeline wrong, but I believe the data analysis and the back and forth between the independent statisticians, the Primary Investigators (on two different continents), the SAB, and independent consultants including lawyers who are understanding of Regulatory Submissions and Approvals all have chimed in. Further, it’s not unusual for partial manuscripts, tables, etc. to be prepared and discussions with Editors occur even before final results are created. This is big for a small company and for these investigators, much bigger than anything they’ve done before. Maybe it’s not been submitted yet to the Journal, and maybe the Journal already has it in Peer Review and there’s a back and forth as to the wording, tables, how much to include, etc. But this is the document they’re going to use to get consensus leaders involved and on board as advocates as well as the Regulatory Agencies of 4 separate domains.
You offer no evidence of anything. You offer no evidence of your experience here. If you have it put it out there and say what you do. Everyone on the board knows my background. Why then is the median time to publication 14.8 months from final data collection? What are all those brilliant people doing for all that time if what you say is so simple that “Linda could knock off a clean draft in a couple of days”. Tell me your timeline, why that’s reasonable, and why you’re making this an issue please. I’ll listen.
