Why did a different FDA team review the resubmission?

Both documents say the review team changed. The letter gives the reason as objectivity. The 8-K says the company learned of the change with the letter and that the new team did not meet with it, and quotes a public statement by a senior member of the prior team.

The letter: To maintain objectivity and account for potential bias, the review team members for this BLA resubmission were different than those who reviewed the initial BLA FDA · Apr 10, 2026 · p. 1. Its conclusion, it says, was reached by that team, supervisory leadership and experts from the FDA's Oncology Center of Excellence, who unanimously determined data presented are insufficient to conclude substantial evidence of effectiveness FDA · Apr 10, 2026 · p. 1.

The 8-K: With the CRL, the company learned that a different review team was appointed for the resubmission and replaced the prior team who had interacted with the company 8-K · Apr 13, 2026. It quotes a senior member of the prior team as having said publicly that the BLA clinical team thought the applicant had provided adequate evidence to support contribution of effect of RP1 plus nivolumab but leadership did not agree 8-K · Apr 13, 2026, and adds: The new team did not meet with the company during the review process despite the company offering 8-K · Apr 13, 2026.

Not in this record: the statement the 8-K quotes, in its original form.