I agree it's not the norm Biosect, but what has the company done that is the norm. I've seen it take many months to get TLD, but never over a year, but here we are, well over a year from the company getting the data and still not even a paragraph on the results.
I believe that the TLD statement is essentially what a company says it is, it's rarely over a page long, it's short on specifics, but it conveys the belief of the company about the product. In some cases it's a failure that's announced, they're abandoning the product. In many cases it's optimistic, but admits that something further will be required that will take time and money. Finally in some cases a company believes that they will be granted approval on the strength of the data.
I believe that our data will be strong, and it will support approval, but that's based on Overall Survival, not on the original acceptance criteria. It's possible we fail on some intermediate statistical goal, but I don't believe that anyone will be able to deny the benefits to those in the trial who've lived for years longer than SOC would have permitted, and many of whom are still alive and in reasonably good health looking forward to many more years.
It's not in the best interest of the company to continue to frustrate investors. if they cannot break the quiet period I believe they still can provide guidance as to when they expect to be able to. It may not be a guarantee that it will happen by a specific date, but it would at least be a target they're looking at.
I think Dave I is doing a good job, most who deal with him are optimistic, but in some ways he reminds me of IMGN CEO decades ago who discussed things happening soon. To us soon was a term that meant weeks or months, to him it seemed to be years or decades. We got to the point that we spelled it backwards when referring to his statements. I can understand that Journals take time, but guidance that's not specific on progress should still be permitted, that's all I believe that I and other investors are asking for.
Gary