RE:RE:RE:What is Pre-BTD Submission to the FDA?Drug application. I posted initially b/c of Dr Uddin's comments in the analst article about "pre-BTD" advice request submission. Then, I thought I found the answer to my own question. It appears to be a real thing. Of course, we have no idea whether Theralase has requested & received such advice. But who knows, maybe that's why they revised the way they were presenting the data and the CR numbers.