Ann: Appendix 4E and Annual Report, page-19

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Gekkowolf

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22/08/21

14:16

Post #: 55478242
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Originally posted by tinyteddy: ↑

The company is not allowed to advertise that it''s available on Special Access Scheme. On social media or anywhere else.

Vrs I agree, but the fact is they did get a CE Mark and they can sell it in EU. I think you need to remember that there are very very few options for these patients. This isn't a new antihypertensive or cholesterol agent. This is likely the factor that swayed the CE assessors, and the same will apply to FDA. FDA has shown this year with Alzheimers, than where there are few options, they will take a balanced look at studies and outcomes. The TGA won;t - Australia has a derivative scientific community and the rigidity is a sign of immaturity not wisdom. NZ is different too - it's frankly typical and ridiculous that NZ has approved it and Australia hasn't.

So, I agree the evidence isn't perfect, but in the face of limited options, some doctors will offer it.

The original sirtex trial was tiny (although controlled) and the larger definitive studies subsequently showed no OS benefit. Yet they developed a solid business because there are limited options and anecdotally the docs felt it had benefit. Then the studies flow after approval and add to the evidence. Same with oncosil. Doctors will use it a bit, then publish their own experience outside of pivotal studies.

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Correct TT. That’s already happening with the interviews of surgeons and doctors.

Plus Oncosil received a write up in Rad Magazine in April/May.

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Ann: Appendix 4E and Annual Report, page-19

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