Pillar 2 - Breast Cancer, page-96

A PRV is granted after a drug for a rare paediatric indication achieves approval.



https://archive.bio.org/sites/default/files/docs/toolkit/FDA-Priority-Review.pdf

The granted PRV can then be used to accelerate approval for another drug in development by the holder of the PRV (or the PRV can be sold).

For this reason I see the potential of a PRV as being attractive to a Big Pharma. The PRV won't directly benefit RACE unless Bisantrene is first approved for Paediatric AML.

A possible scenario where the PRV might benefit RACE is if RACE achieves approval for AML for a cohort of patients classed as paediatric. A trial for children is unlikely to start until after a trial in adults has reported first readouts. I don't see a trial for a paediatric group of patients starting until 2022 at the earliest.

I think RACE could be bought out before a Paediatric trial even starts since:

1. Breast Cancer trial is starting in 2021 and will likely have first readout in H1 2022
2. AML trial in adults is starting in 2021 and will likely have first readout in H1 2022
3. Preclinical data for FTO will be reported in 2021

These 3 things together are the main things that could trigger a buyout ( which is likely before a Paediatric trial reads out sufficient data for an FDA approval for Paediatric AML ). At the moment I don't see the FDA approval condition being met for a Paediatric condition until 2023 at the earliest.