Biotech Values

[iwfal]

That's your read, not my read based on FDA Review:

Ok. Understand how you read it that way. But I think it is ambiguous given the huge difference in what it means for result contamination. Almost blasé about the distinction which I'd suggest they wouldn't be if they knew a large number of people had access to the unlocked database at interim. So I read it as more along the lines of defendant's attorney assuming the worst unless there is proof of chain of custody.

PS this important distinction may be why there are such polar sides in the twitterverse. One side thinks of this as just a topline results thing, and the other ... .

it happens in small biotechs more often than outsiders think especially for non-registration trials because they don't have strong SOP or follow SOP strictly.

I have no doubt whatsoever that biotech, especially small biotech - but sometimes even big Pharma - violate data cleanliness protocols sometimes. Especially for non-registrational trials. But my question was if anyone has a scenario where a top line result release (only) at the interim somehow caused a substantial bias at the final. I've never seen a really plausible/credible scenario.