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Posted On: 10/20/2020 6:40:36 PM
Post# of 148892
The BLA was finished two years ago for the FDA, not for the UK. We've been in the process with the FDA since, constantly having to adjust something or give them different data that they request. Yes, in theory they could have also given that package to the UK and gone after approval over there. But we're talking about a pre-revenue company in the US trying to get their little drug over the finish line in their own backyard. There wasn't and isn't endless amounts of time and money to seek every possible approval path around the world. They chose the US and now that we are in a better position, and a different position because of Covid, they are going to use that same finished packet to try for approval in the UK now. Would have been great if they'd done it years ago but it likely wasn't really a possibility then.
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