US full FDA approval will take time but sale data from NZ and EU...

US full FDA approval will take time but sale data from NZ and EU is important... IMO.

What is interesting in this announcement that the application was withdrawn with word " the Company has decided to withdraw the application on the basis that the provision of additional clinical data comparing the performance of the OncoSilTM device directly with other standard therapies is expected to support the application" now question for OSL is "did TGA provided written advice to OSL that their application will be supported with comparison data?"

if TGA has not provided written correspondence with a statement that "a comparison data support the application" then why OSL in their Business transcript issued on 26/02/2021 page no. 4 Nigel's response to Shane Storey says "However, we believe that we’re not competing with existing standard of care chemotherapy." so now OSL can not assume contrary to what they believed all along that they are not competing with existing standard of care as if they are not competing then they can not provide competing data.... !!! They can not withdraw application from TGA by making assumption contrary to what they told shareholders.... IMHO.

IMO it would have been better to kept the application with TGA until next Thursday meeting to get TGA decide (may be rejection) but if TGA reject application then they would provide reason for rejection IMO and in that reason it will be easy for OSL to ask "which standard of care do you expect us to compete with?" and we as a shareholders know what happened with the application and also company could have clear path on resubmission.... IMO.

I have my doubt on the management now... on how they removed previous CEO and how they were silent on Hong Kong Approval for few days.... and now they started believing what they didn't believe earlier... I am sure they are not kids to change their believes so easily ... IMO.

More clarification and justification needed from management on their reason for withdrawal and all of sudden change in their believe and if they really changed believe then time is up for the board who change their believe in a matter of few months (Feb announcement vs June withdrawal)... Also require clear future direction for TGA and FDA approval and key sale milestone target they are aiming to achieve over next six month.... IMO.