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Posted On: 01/08/2020 6:43:53 PM
Post# of 149028
CTC levels are checked every 21 days. With the checks on time to new metastases I would expect the very end of February, very early March for BTD submission.
Since a sufficient number of patients would be needed to try and file an early BLA submission, the timing of a BTD submission is not crucial.
https://clinicaltrials.gov/ct2/show/NCT03838367
Since a sufficient number of patients would be needed to try and file an early BLA submission, the timing of a BTD submission is not crucial.
Quote:
The change from baseline in circulating tumor cells (CTC) level in the peripheral blood. [ Time Frame: Every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months. ]
https://clinicaltrials.gov/ct2/show/NCT03838367
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