FWIW...
IMU clearly stated that the p1a would consist of numerous dose expansion cohorts (9-18 patients). Then, once the optimal dose was established, the last remaining cohort would add an additional 10 patients.
This clearly didn't happen -
https://cdn-api.markitdigital.com/a...pdf?access_token=00077ukb38ol9ODU1nyBxp6GFjA2
There was a total of 14 patients enrolled in the p1a dose expansion study and only 4 of those were dosed in the final 'optimum' cohort.
This dose expansion cohort looks to have been cut short after a Grade 5 adverse event (fatal). Based on the stated trial design; it would appear,
although not certain, that the grade 5 event occurred in the final, optimal dose cohort. This concerns me.
IMU look to have rushed through the P1a, based on their own submission to clinicaltrials.gov, and into p1b (combination). They now appear to be terminating the trial with a total of 24 patients enrolled. This is against a planned patient population of at least 67 but up to 94.
It's possible, and I hope, that the 10 patients that received the combination therapy have achieved some outstanding results and that IMU can license the B Cell platform for
@AlCp's forecast of $400m. But I'm not willing to take that risk based on the above.
Any acquirer should go back to the drawing board because the initial 10μg cohort arguably delivered better results than the 50μg and 100μg cohorts (25% CR rate).
(20min delay)