Replies to post #31600 on Marker Therapeutics Inc (MRKR)

[Phantom Lord]

The BLA is only filed after they have data to support a review. If the optimistic timeline holds, and while early it looks like it will, then we should see interim AML data on the active group end of Q1 2022 and potentially the full readout mid 2022 (sometime end of Q2 or beginning of Q3). If data is good enough to support a review then I would expect a BLA filing by the end of 2022. Since MT401 does have orphan designation I would expect a decision from the FDA no later than mid 2023. This is not an absolute timeline but just based of my best guess from the DD I have done.