No offense suzuki, and I'm no expert in the difficulties faced by Aussie bio/medtech, but I am very experienced in biotech and especially with small to tiny US pharmas and their investors say the same thing, that the deck is stacked against them with the FDA. I understand where that sentiment comes from and acknowledge that large biotechs, whether they be in the US or not, do have advantages with being able to afford extensive expertise or with even having privileged access to FDA personnel that small companies don't, but my experience is that data ultimately rules and that the FDA greatly wants to approve drugs or devices that can make significant improvements in patients' lives.
I feel confident that if Anteris submits the required documentation to the FDA backed by strong evidence, that submission will be judged on its own merits. That doesn't mean I'm against a buyout, I'll gladly take a big profit on way or another, but I don't have nearly so dire opinion of the chance of approval. And I think we could probably make a lot more money in the long run going it alone, even though it is more of a gamble. Just my opinion.
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