Assess whether to drop a secondary endpoint that will dominate the AdCom

SITUATION The working file is disproportionate reporting signal workbook after a site-change that invalidates stability claims. Labeling negotiator in an RWE group proposing a post-marketing study instead of a new RCT has to name Proceed under protocol or Pause the pathway for this Pharma & Life Sciences Clinical and Evidence Strategy file.

DECISION Labeling negotiator in an RWE group proposing a post-marketing study instead of a new RCT must choose Proceed under protocol / Pause the pathway / Escalate safety review / Hold using disproportionate reporting signal workbook after a site-change that invalidates stability claims.

HYPOTHESES TO TEST 1. Disproportionate reporting signal workbook reads as Proceed under protocol once a site-change that invalidates stability claims is lined up to the same Pharma & Life Sciences population. 2. Disproportionate reporting signal workbook is closer to Pause the pathway after a site-change that invalidates stability claims; Proceed under protocol would over-claim this Clinical and Evidence Strategy extract. 3. Escalate safety review is still live in disproportionate reporting signal workbook for labeling negotiator in an RWE group proposing a post-marketing study instead of a new RCT. 4. Disproportionate reporting signal workbook is missing the fact labeling negotiator needs after a site-change that invalidates stability claims; stop this Pharma & Life Sciences close.

ANALYSIS REQUIRED 1. Trace CMC, labeling, or pharmacovigilance facts in disproportionate reporting signal workbook after a site-change that invalidates stability claims. 2. Separate an isolated adverse event from a systemic quality issue. 3. Test a protocol deviation versus a safety signal versus a filing gap on to drop a secondary. 4. For this Pharma & Life Sciences Clinical and Evidence Strategy file, read disproportionate reporting signal workbook against a site-change that invalidates stability claims and write the one fact that would move to drop a secondary for labeling negotiator.

RECOMMENDATION Choose Proceed under protocol / Pause the pathway / Escalate safety review / Hold on this Pharma & Life Sciences / Clinical and Evidence Strategy packet (disproportionate reporting signal workbook after a site-change that invalidates stability claims). Lead with the Pharma & Life Sciences option disproportionate reporting signal workbook can support after a site-change that invalidates stability claims, then the two facts that force it, then the Monday action for labeling negotiator in an RWE group proposing a post-marketing study instead of a new RCT.

COMMAND RETURNS - Bottom-line Pharma & Life Sciences option on to drop a secondary, then the evidence in disproportionate reporting signal workbook, then the action for labeling negotiator - Hypothesis scorecard against disproportionate reporting signal workbook: supported / rejected / untestable - Owner and next date for labeling negotiator in an RWE group proposing a post-marketing study instead of a new RCT - What changes to drop a secondary if a site-change that invalidates stability claims is later withdrawn