Marker Therapeutics Inc (MRKR)

[microcapbiotech]

GOOD? BAD? Clinical hold lifted and the FDA permitted the Company to initiate its AML trial, beginning with a safety lead-in portion.
On SIX patients, 3 with reagents from old supplier and 3 from new supplier.

Certificate of analysis required by the FDA, by the end of the second quarter of 2020 (JUNE)?

Final technical specifications and comparability data of the new reagents to the FDA during the second half of 2020 (December)?

The safety lead-in will be followed by the 160-patient randomized portion of the study at approximately 20 transplant centers (in 2021)?

First 120 patients, primary endpoint of relapse-free survival.

And 40 patients, primary endpoints of complete remission and duration of complete remission. Primary endpoints of Complete Remission, GEEZ, REALLY? Can you set the bar any higher. Does the FDA want the patients to start peeing liquid gold too.

Seems like a long road timewise, and a very steep upward road at that.

Sure hope we get another or two complete remissions from the patients we are already working with.

ANY OPINIONS: PHANTOM? THELITTLEGUY? XENA? ANYBODY?