Well it's not total BS. Back in February they said.
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Based on data Marker provided, the FDA permitted the Company to initiate its AML trial, beginning with a safety lead-in portion. The FDA placed a partial clinical hold on the trial for the use of the MultiTAA-specific T cell product manufactured using one of the reagents supplied by the alternative supplier, until the final data and certificate of analysis for the reagent are reviewed and accepted by the Agency.
The safety lead-in portion of the trial is expected to enroll approximately six patients as part of the amended trial design. Three patients will be dosed with MultiTAA-specific T cells manufactured using the legacy reagent, and three patients will be dosed with T cells manufactured using the reagent from the alternative supplier.
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I found it odd (and typical for the FDA) to stop the trial because of a reagent and then approve a lead-in to the trial but they HAVE to use the old reagent.
Wait, What? We found a new supplier! Too bad, you still have to use the old one too.
It's time they get started. No; it's well PAST time they get started.
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