RE: This is what I'm thinking10 May 2024 07:41
@LL&P, there are 2 parts to reach cohort study: safety & tolerability, with efficacy showing during the second part.
The safety part is 2 doses followed by a two week observation period and then SDMC review. It doesn't matter when the first patients were dosed for Q2W cohort 1, the important dosing was patient 3's first dose as, so being well, the end point for the safety evaluation would be 4 weeks later. That we are now 7 weeks later strongly suggests, given the importance of completing this trial in the project timelines, that there has been a problem with one of the patients. Although incompetence in not arranging a SMDC [sic] review can't be ruled out.
The multiweek surveillance is part of the second part and is to monitor the patient, including measuring tumour sizes.