Type B FDA meetings are publicly communicated. Following NWBO's P3 trial completion, they requested a Type B meeting to share the data and ask FDA if it is sufficient for a BLA application. FDA provides guidance as to whether the data is sufficient for considering a BLA application. If FDA says it is not, the biotech (NWBO) knows that more clinical data or go to other regulators to try for approval.
FDA does not normally make any public communication about the content or even the occurrence of a sponsor’s Type B meeting (including pre-BLA).
Type B meetings are governed by FDA’s “formal meetings” guidance, which sets timelines and procedures but does not contemplate routine public disclosure of meeting requests, briefing books, minutes, or advice. Under FDA’s disclosure regulations (for example, 21 CFR parts 20 and 314.430), information shared on pending applications and related communications is treated as confidential commercial information (CCI) and not disclosed unless the sponsor has already made it public. NWBO has the right to release any information of the results of the Type B meeting but has not made any communication. But NWBO clearly knew that FDA wouldn't accept an application so they made a quick pivot to filing in the UK with the MHRA without explaining why.
The sponsor often chooses to disclose that a meeting occurred or what feedback they received (e.g., “FDA has agreed that our Phase 3 trial is adequate to support an NDA”) via press releases or SEC filings; that is company-driven, not FDA-driven.
This is why there is no public communication of why FDA would not accept an application. But the evidence is clear when NWBO did not file and did file in the UK, a much smaller market, 1/10th the size of the U.S. NWBO has previously refused to release any information about the FDA action in the partial hold on their P3 trial. So it is not at all unexpected that NWBO would not provide any information of the FDA Type B meeting direction from the FDA.
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