OSL oncosil medical ltd

What happened to FDA approval?, page-2

  1. 927 Posts.
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    No. FDA don't care about CE Mark.

    And, in reality, FDA approval is worth much more than CE mark in terms of sales. Much more.

    They will need to partner to progress this through FDA.

    I would have though that given the terrible state of pancreatic ca treatment, they could get FDA approval for compassionate use fairly easily. But even so, the time not advancing this is being wasted.

    This partnering could and should be happening now. It will be that partnering discussions are influenced by CE mark approval. Potentially CE mark makes a deal much more valuable to OSL. But delaying partnering and thus delaying FDA progress is also costly and in my view always a stupid idea. Why? because new stuff comes along. These guys need to learn to walk and chew gum.



 
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