Agreed that the order has been in process but in n
Post# of 148337
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Posted On: 03/27/2020 9:04:07 AM
Agreed that the order has been in process but in normal times the manufacturer needs to be FDA approved (which Samsung is), the validation batches need to be concluded with summary reports signed off by the quality department.
This assumes that the CMC process is approved by the FDA already.
Since these are not normal times and the trial is 6 weeks - there is time to get these commercially necessary activity completed and hopefully FDA approved.
IMO
This assumes that the CMC process is approved by the FDA already.
Since these are not normal times and the trial is 6 weeks - there is time to get these commercially necessary activity completed and hopefully FDA approved.
IMO
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