Ann: Appendix 4C Quarterly Activity Report, page-64

You'll recall the FDA, in its ODAC submission, did indeed call into question efficacy, so that hurdle is yet to be jumped despite the ODAC input.

While the ODAC vote was indeed 9-1, the transcript shows the participants did not have an overwhelmingly positive view, so you get comments like 49/51, but safety got me over the line. Indeed the overwhelming impression from the discussion in the transcript was that it's safe, it might or might not work, there need to be further trials, there's few alternatives, so let's give it a go!

The FDA stance is perhaps best summed up by this quote:

"Therefore, it is unclear how to interpret the results of one statistically-positive single-arm trial in a landscape of multiple negative clinical trials, including several randomized, controlled trials that failed to show a treatment effect."

You'll also recall the FDA scepticism around the appropriateness of 45% as the null Day-28 ORR, an issue that still remains to be addressed.

Some water still to flow under this particular bridge!!