Pillar 2 - Breast Cancer, page-94

On this note, do we know if a PRV is still in sight for RAC @RaceOncology? It hasn't been addressed anywhere for a long time as far as I can see. Was hoping the AGM would have brought some light to it, but can't seem to see it in my notes. Whilst it isn't a big deal now in the scheme of things, it would definitely be enticing to package up with the RAC bundle at sell-off time. I wonder though, now with FTO in play PRV may be harder to achieve with such a large addressable market. Imagine the deck presentation:

1. Previously approved for AML in France, over 2000 patients in over 40 clinical trials - no significant long term safety issues noted
2. PRV to advance your drug quicker in the 6month period it grants
3. Already proven in P1/2 in ~8 disease states, targeted to highlight 3 different mechanisms/applications (3 pillars) and shown efficacy, all ready for you (big pharma) to do the P3 the way you see fit

It'll be so neatly bundled that you'd almost be tempted to take it all the way, but I'm more than sure big pharma wouldn't want it to get away from them by then. I've attached below a summary of the PRV that I found helpful. As @mcexplorer noted though, PRVs are readily sold between companies to fast track approvals - a handy way to fund RAC through the long term should that be the tactic?

I'm firm in my belief that news hasn't been baked in, as we've had some incredibly impressive Ovarian and Breast CA news over the last few weeks and have not adjusted accordingly imo. Holding on tight for the next few weeks and will not budge on the impending volatility. If there's one thing that RAC has proven to me, it's that with such low SOIs, 'gaps' don't seem to be readily filled, and retraces (if at all) are very very short lived. I feel the George Clinical scoping study will provide a lot of answers as to the direction forward - FTO ++.