Thanks TT for your considered views. I would also add that FDA...

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Gekkowolf

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02/02/22

13:44

Post #: 59301277
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Originally posted by tinyteddy: ↑

I hate to think.

Approval for anything from FDA is a big sign to the market that the product has enormous potential. So while the sales from the HDE approval won;t be huge, the impact on the acceptance of the company will be. In a sense, FDA are looking at the Panco study and deciding if they think there is good safety data and potential for effectiveness. They still need a randomised trial to approve it for pancreatic cancer, but allowing its use in any way means that think its safe and see the value of it based on current work. Which is worth a lot.

I'm still encouraged by the presentations on file at FDA where they have already classified under what regulations oncosil would be approved.

I'm also still of a view that the indication "distal cholangiocarcinoma" is really just a backdoor indication for some pancreatic cancers. However, there is effectively no treatment for cholangiocarcinoma, so it lowers the bar in terms of approval. I guess thats why it was chosen.

Getting approved in any capacity means US doctors get to see it and use it occasionally, which is extremely important, as the funds in the US for research are vast.

So, in summary, I guess that not getting approved wouldn't mean that much in terms of sales, but it would in terms of reputation. And that would affect its ability to raise capital from the US.

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Thanks TT for your considered views. I would also add that FDA approval for bile duct cancer would make eventual sales in the US more easy since Medicare reimbursement would be available. So, I think getting FDA approval for bile duct would be a huge boost for Oncosil.

OSL Price at posting: 4.0¢ Sentiment: Hold Disclosure: Held
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Thanks TT for your considered views. I would also add that FDA...

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Thanks TT for your considered views. I would also add that FDA...

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