GREY:IMVIF - Post by User
Post by
bikkel78on Dec 10, 2020 6:31am
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Post# 32074852
Breakthrough Status for DLBCL
Breakthrough Status for DLBCL I spoke to the company and they are convinced they will get Breakthrough Therapy designation from the FDA. The biomarker data is so strong, this will propell the stock into 2021!
Drugs that have been granted breakthrough status are given priority review. The FDA works with the sponsor of the drug application to expedite the approval process. This expedited process can include rolling reviews, smaller clinical trials, and alternative trial designs.
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