OSL oncosil medical ltd

Gekkowolf you could be right and wrong on the need for FDA...

  1. 304 Posts.
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    Gekkowolf you could be right and wrong on the need for FDA approval in the US.
    Sirtex, got their approval in the 90's when the clinical trial hurdle was much lower - all power to them. When the rules changed and the FDA approach with it that cost became huge and the endpoints unreachable.

    Therasphere tried to go that that route, was a huge cost and took them more than 15 years to get approval. However they did make a large business under HDE which was enough for Boston Scientific to buy them.

    Its not impossible but a huge mountain to climb. Whats more important for Oncosil in the US is reimbursement, utilisation, peer adoption and enough data for the commercial insurance companies to pay.

    The EU and ROW is aways going to be a dog and a drain on resources. If you cant crack the US you might as well go home. Throw everything at the US, the rest is only good for news flow and a distraction just now. US first ROW later.
 
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