RE:RE:Fast Track + PR (CR) = Accelerated ApprovalNoteable,
You have mentioned this in the past but I did not really understand its implications. If I understand correctly, there is actually nothing stopping ONCY from applying, given the dire nature of panc cancer and our results.
If that status were granted in combo with Roche, we could be selling pela during 2023.
That is a huge win-win-win-wim: for patients, regulatators, Roche and ONCY shareholders. No losers that I can see.
Moreover, the panc combo of Tecentriq plus chemo is ALREADY APPROVED and being sold, IIRC. Adding pela is not going to make the combo a greater safety concern. So there is no real obstacle.
Maybe we can draft up some kind of letter of application to send to ONCY, or a petition among panc patients, to prompt the company (jk).