Regulatory . MHRA still asking questions . NICE submission had contractors working on it a year ago and now crickets . FDA. Other RAs were a priority 2 years ago and now not going to happen until after an MHRA decision.
Trials . Direct: Supposed to start this last year (like 2015,16,17,..._). Now officially on the shelf . Roswell trials: inlicensed trials have been suspended (though if longs have ID'd the correct trials they have been completed/terminated with a total of 1 patient) . Combo trials: Not the hoped for -L combo, but an early stage trial with some Roswell tech that will likely be starting 2027 or later.
Manufacturing . Eden: Previously had a GMP design complete and now have 2 contract firms working on it. Oh, and 2 feet made it too big to fit in a cleanroom? So I guess they are not getting dozens in as longs suggest. . Class C; A month ago supposed to be complete in Q2 2026. Now not starting until end of Jan
At least they did not show video of the man in the red hoody.
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