This is an important point in terms of what Pharma view as derisk v. development stage.
If we take a new molecule that is going through it’s first P1-P2-P3 then efficacy and safety are paramount. Often this remains uncertain until P3.
Bisantrene is different in that it has 50+ trials and approval under its belt. Also the recent ODD and RPDD is testament to FDA acceptance of the Bisantrene API.
My thoughts are the derisk point is bought forward from a Pharma perspective due to the following;
- Mechanism of action / scientific publication / peer review
- CPACS readouts anti cancer cardio protective
- Break through designation status
- More preclinicals
The market narrative of ‘wait and see’ to P3 is stronger IMHO so a lot of heavy lifting to change this perception. How?
- Regional licensing
- Industry / KOL interest / conferences
- Early stage development partnership
- Lots and lots of education (PR)
Feel Race has good momentum and communication at the moment. Hopefully this continues!
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