RE:RE:RE:RE:Clinical Trial Size in Orphan and Rare Diseases With 10 SCCA (anal carcinoma) already enrolled in the GOBLET-1 cohort study it would likely require just another 10 more clinical trial patients to be enrolled in a follow on study at a total cost of under $3 million, to be sufficient for ONCY to gain FDA drug approval for pelareorep in this rare disease indication.
The achievement of gaining FDA drug approval in this rare disease indication would significantly raise pelareorep's profile as a treatment option for the various other cancer indications that ONCY is seeking approval in, namely HR+/HER2- mBC, PDAC, and GI cancers.