Tuesday, November 22, 2016 6:52:51 PM
Here she is, talking to Doctors that know a crossover in any trial may confound treatment effects and/or placebos can over or under perform. The question is by how much -- if at all? She did not know because the results are still blinded. However, she certainly did not expect everyone to be living longer than expected, and yet that seemed to be the case.
You and AF find failure of the trial in her announcement. However, she could not know this because the results were blinded. Therefore, you don't know from that presentation whether the trial succeeded or failed.
Crossovers help patients but not necessarily trials. Duh. The FDA required it. IMHO, they will look at the difference and if PFS was strong, likely look for a minimum of no adverse trend for OS, then depending upon the results, either grant full approval, accelerated approval with more trial info required on OS after this trial matures to obtain full approval, or accelerated approval but also require a new OS trial. IMHO.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
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