This ODD just added at least another 4.5 + mill in AUD value...

This ODD just added at least another 4.5 + mill in AUD value through savings alone...

”... It also results in a waiver by FDA of fees for a marketing application, under the Prescription Drug User Fees Act (PDUFA fees), which are just under US$ 3 million in FY2020. In addition, drugs with ODD may be eligible for orphan grants by FDA.”

there is also Fast Track Designation which no doubt has been applied for in Glioma including DiPG which can be seen from this table in the release - note a vacant box and not an n/a


More good news on the way!