Avid Bioservices Inc (CDMO)

[mskatiescarletohara]

TW..nope, the NABTT has decided upon the therapeutic dose as part of the registration study. There wasn't enough data accrued in the Phase I and Phase II studies to support dose confirmation, dosimetry, and labelling, furthermore, they have to test twenty eight patients for the planned dose for recurrent glioma specifically.

If you will review the old datum, you'll find there were several different doses tested on different types brain tumors. These studies helped determine which dose was best on which type of brain tumor.

PPHM and NABTT have determined the dose they want to proceed with and now will meet the objectives outlined in the registration study for approval. PPHM making the decision to proceed with a registration study was sound strategy given the indication is for recurrent glioma. They would never be able to enroll two large pivotals in a timely manner, would cost way too much as well. The FDA SHOULD by all means accept data from one pivotal for this indication since it is deadly and has orphan drug status.

katie...