Very smart people make this mistake all the time. More to the point, CROs make this mistake on behalf of smart people all the time.
It is actually rare in P2 randomized trials to randomize by center or even by country. Oncologists and management teams have a blind spot about cancer in that they think patients are all the same regardless of the country. Some realize this isn't the case, but not many.
We see small biotechs enroll outside NA/EU and then have their P3s run in the EU/NA blow up all the time. How many P2 trials run "cheaply" in Russia resulted in blown P3 trials run in the US?
Lots.
It's a good question to ask management.
Unless otherwise indicated, this is the personal viewpoint of David
Miller and not necessarily that of Biotech Stock Research, LLC.
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