Avid Bioservices Inc (CDMO)

[freethemice]

Bungler, I agree with you. I don't think the trial data was violated and the double-blind was not broken.
No one knew about any of this until the last 3 weeks at most when the data was being given a complete
going over in preparation for the meeting with FDA. Even if some of the data couldn't be used and the statistical
significance of the pooled data was reduced there is no requirement from the FDA that you have to have
statistically significant data to start a phase 3. If that were true very few phase 3 trials would have been done.
I also feel that the independent monitoring board saw that the two treatment arms were giving results so
alike at the time of unblinding they felt that it was statistically valid to do a pooled analysis. I don't think
they knew of the "problem" with the treatment arm samples and were trying to some how "fix" it.