My oxymoron alert went off when you wrote "completely transparent" in a paragraph about any biotech and their protocols/results. You have been involved or at least watched the obfuscation and tap-dancing of dozens of CEOs and CSOs when asked direct questions about trial issues. I have never expected transparency from any biotech and we all spend lots of time trying to unwind the confusion (ie: this board).
I don't think that the Ph III protocol is very complicated at all. Part 1 has to pass a PFS endpoint for the trial to continue. The primary endpoint for the entire trial is survival. The survival of the patients in Part 1 can be followed in parallel to the enrolling of part 2 and the total enrolment is adapted to the stats of Part 1. As compared to HIV, Alzheimer, MS, Prostate cancer, obesity trials, these stats are a walk in the park. Not much screwing around with a primary endpoint of overall survival.
All of my information comes directly from conference call questions, conference discussions or calls to the company. I attend the conferences where the raw data is presented. After lots of talking, the information slowly crystalizes.....it is not perfect, but it is better than a guess or conjecture. Sometimes, conflicting ideas come up and it is time for a call to the company. I find them pretty open to discussion if you ask reasonable questions.
Cheers, Geneman
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