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drkazmd65

05/15/24 4:26 PM

#43758 RE: imanjen13 #43757

You might be a bit optimistic on the 'before the fall' comment for getting full enrollment. Otherwise I agree with your point here.

Back in late 2015, they were enrolling a steadily climbing 25-35 patients per month for the main Phase III trial. They did enroll a total of 340 patients during the whole of 2015 though. Assuming they push as hard as their CRO did in that year, I could see enrollment by end of Q1 of 2025 though. Once enrollment is filled - they should have data for an initial phase 1 (lower case intended) readout of their confirmatory trial by (I would guess) the next quarter.

Also, keep in mind, that the confirmatory trial has a more limited pool of patients than did the world-wide trial BECAUSE they are going to focus in on a subset of the potential patients with their confirmatory trail. I was tracking enrollment fairly closely back in 2015 when I still occasionally wrote summaries on Seeking Alpha. Part of how quickly they can fill a new trial is going to depend on how much human and financial capital they have available to throw at the problem.

https://seekingalpha.com/instablog/1033940-just-one-lab-nerd/4684406-cel-sci-company-cvm-continues-to-slog-forward-in-populating-phase-iii-trial-for-multikine