O'Brien-Fleming spendinf function-Hodag | NWBO Message Board Posts


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Msg  16745 of 17014  at  9/20/2023 7:02:58 AM  by

longfellow95


 In response to msg 16742 by  Hodag
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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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