Avid Bioservices Inc (CDMO)

[nuke661]

Thanks for the information co3aii.

It certainly appears to be pertinent information that we should keep in mind when assessing the location and ethnic makeup of a trial population. It would seem to me that the US FDA would especially be looking at this issue due the wide ethnic diversity of this country.

I would also assume this issue is known to the US FDA. If so then the regulators should be looking for data from drug trials to address this issue. If regulators are looking for this issue to be addressed by drug trials then the regulators would almost certainly have provided regulatory guidance/requirements on the ethnic diversity in the makeup of clinical trial populations.

Therefore, I believe that the planners of the PPHM trials would have to know about this issue (if applicable to PPHM's trials) and have or, will have, the necessary plans to address it when and if necessary; or they would have no business in this business.

I would think that once past the issue of safety (usually occurring in phase I) this issue would most likely be addressed in a Phase III study where the largest patient population is required, which would allow the best opportunity to evaluate a drug's actions on a variety of ethnic populations.