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Re: O'Brien-Fleming spendinf function-Hodag"Which brings us back to the key question; when is the company going to submit a file?" If you are specifically referring to the FDA, I'll hazard a guess at 4 or 5 years time. I don't think you fully appreciate their existing filing strategy. An FDA filing is clearly not seen as a priority. When they do go to the FDA, they will want to be armed with more post-marketing real-world data derived from the priority jurisdictions. |
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