Will the FDA grant a resubmission path (not new-trial) for relacorilant Cushing's by 2026-06-30?

Industry base rate for specialty NDAs with existing clinical data leading to resubmission path post-Type B meeting is 50-70%. Corcept's revealed-preference signals are strong: 60 to 175 rep endocrinology expansion and maintained $3-5B Cushing's forecast only make economic sense under resubmission assumption. Lifyorli's 4-month PDUFA acceleration signals functional FDA-Corcept cross-divisional relationship. Offsetting: management's qualitative credibility discount (GAP_BULLISH across three guide cuts), and the strict 2026-06-30 disclosure deadline creates a ~40% chance that a resubmission is agreed but not formally 8-K disclosed within the window. Net probability lands slightly above base rate at 0.58.

Two pull-forwards from base rate: (1) CRL public record did not disclose safety or efficacy fundamental failure, which suggests the deficiencies are amendable; (2) FDA Oncology division's 4-month PDUFA acceleration on Lifyorli demonstrates the agency is productively engaged with Corcept on the SGRA mechanism class. Two pull-backs: (1) the 2026-06-30 resolution date requires that the April meeting outcome be formally 8-K disclosed within roughly 8 weeks - realistic for material events (4 business days standard), but if outcome is 'ambiguous' (resubmission requiring additional clinical work), the disclosure may classify as 'additional clinical data' which resolves NO under the strict criteria; (2) Endocrinology division and Oncology division operate independently, so Lifyorli signal transferability is weak. Probability 0.52 reflects coin-flip-plus given these offsetting forces.

The decision-tree structure: P(meeting yields resubmission path) * P(disclosed by 6/30 | resubmission agreed). P(resubmission | meeting held) is probably 0.65-0.75 given revealed-preference signals (SG&A buildout, guidance, management conviction) AND the fact that FDA CRLs on specialty orphan NDAs with existing Phase 3 data rarely require full new Phase 3 in practice - more commonly they ask for additional analyses, dose justification, or label modifications. P(8-K by 6/30 | resubmission agreed) is approximately 0.85-0.90 given the 4-business-day standard for material events. Joint probability approximately 0.65 * 0.88 = 0.57, but with upward adjustment for the meeting having already been scheduled for April (so minutes will have been received by May, giving 6-8 weeks buffer for disclosure). Lands at 0.60.

The question is really two questions: will FDA grant resubmission, AND will Corcept disclose it by 2026-06-30? On the first: industry base rate is 50-70% for specialty NDAs; Corcept's SG&A buildout and management's continued $3-5B forecast are strong revealed preferences. On the second: Type B meetings in April produce written minutes ~30 days later (late May), and Corcept has a 4-business-day material event disclosure obligation. Both resolve favorably in most scenarios. However, Myth Meter's GAP_BULLISH read on management credibility cautions against reading management's signaling as probabilistic. Net: slightly above coin-flip at 0.55.

The strict resolution criteria are important. Resubmission 'path' means NO new trial required AND path is amendment/analyses/label. Many Type B meetings produce outcomes like 'submit additional clinical data' which would ambiguously resolve between YES and NO. The disclosure threshold adds friction - a conciliatory but non-definitive outcome might delay 8-K until clearer. Management credibility discount (three prior guide cuts) means their revealed-preference signals should be weighted at ~0.6 rather than face value. Net: slightly below coin-flip, reflecting strict criteria + ambiguity risk.

Rational base rate of 0.55-0.65 for specialty orphan NDA resubmission paths, anchored by: (a) Lifyorli's rapid approval demonstrating Corcept-FDA working relationship is functional, (b) Corcept's substantial SG&A commitment, (c) CRL public record not disclosing fundamental failure, (d) management's confidence rhetoric (to be discounted, but not zeroed). Timing risk for the 6/30 disclosure deadline is ~15-20% (most material events are disclosed promptly but aggregate Q2 earnings timing in Aug could absorb the disclosure if meeting runs late into April). Net: 0.56.

Base rate for FDA resubmission path on specialty orphan NDA with existing Phase 3 data is about 55-65%. Corcept's SG&A expansion and maintained $3-5B forecast are consistent with operator expectation of resubmission. Discount slightly for management credibility and disclosure timing risk. Probability 0.55.

Coin flip with mild tilt. Pro: industry base rate 50-70%, operator buildup consistent with resubmission, Lifyorli process signal positive. Con: strict criteria (no new trial required), disclosure by 6/30 requires clean meeting outcome. Management credibility discount offsets operator-signal weight. Settle at 0.50.

FDA Type B meetings on specialty orphan NDAs with existing Phase 3 data and clear reformulation pathways tend to resolve favorably toward resubmission in 55-65% of cases. Corcept's operator preference signals (SG&A + guidance maintenance) pull slightly above baseline. Timing risk on disclosure is 10-15%. Net 0.57.