304 - If a PAAB opinion is requested for a specific, does a positive or negative opinion affect the outcome of a subsequent clearance review?

  • You'll see that there is an association between opinions and latter submissions of same/similar content. This is best described as a correlation (which is indicative of consistency) rather than a causative relationship. For example, if XYZ is not acceptable, it will be questioned whether it is submitted as an opinion or a full submission. However, the fact that something was questioned earlier does not in and of itself render it unacceptable (what renders it unacceptable is likely whatever triggered the comment in the first place). Note that this correlation is not absolute. On occasion, something is questioned in an opinion submission, but is accepted in the following complete submission because the client addressed the concerns (e.g. by providing acceptable evidence to support the claims and/or by adjusting the context). Submitting an opinion does not impact the PAAB timelines associated with the eventual complete submission. However, the line by line review during the complete submission process may run smoother if PAAB feedback from the opinion is incorporated onto that complete submission.