Ann: OncoSil TGA regulatory update, page-25

it means that the submission was likely to be rejected so company’s decided to withdraw it rather than have to accept a formal and public rejection which could be damaging. It allows them to go back later with new data. It’s not unheard of to withdraw.

it also means Tga must have taken harder line than BIS/ CE mark and need more proof of the device’s efficacy. Probably they’ve taken more of an FDA line. My hunch is they will need to go back with a randomised control trial showing unambiguous evidence device adds benefit over standard of care chemotherapy. That’s really the only way. I can’t think current trials will now provide anything new now.

disappointing that the device won’t be available in the home market though, probably not for a long time. Perhaps they should all relocate to Europe.