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Posted On: 10/27/2020 9:07:00 AM
Post# of 148908
For me the real importance of the MHRA’s clearance for BLA @ 350 mg lies in the fact that this puts the FDA under a "sword of Damocles".
Now, there is the possibility that we will get approved somewhere else in spite of their slow-rolling us and their shenanigans' in benefit of their BP sponsors through the last years.
What it is really important here is not U.K.'s approval and market (of course important). Is that they believe we are can be approved (after review, of course).
So, FDA: you time is up. The genie will be out of the bottle soon !!!
Now, there is the possibility that we will get approved somewhere else in spite of their slow-rolling us and their shenanigans' in benefit of their BP sponsors through the last years.
What it is really important here is not U.K.'s approval and market (of course important). Is that they believe we are can be approved (after review, of course).
So, FDA: you time is up. The genie will be out of the bottle soon !!!
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