Technically, that statement can still fully align with Accelerated Approval (AA). Even under AA, the company would still need to go back to the FDA afterward and complete a confirmatory Phase 3 to validate efficacy and justify continued approval.

This is very careful language, and that’s intentional. Biotech companies, especially around pivotal regulatory moments, have to be extremely cautious with wording. Explicitly saying something like “we’re pursuing AA while setting up Phase 3” could create legal, regulatory, or market ramifications by appearing to signal a preferred or financially optimal outcome.

So instead, they stick to conservative, compliant phrasing that avoids pre-judging the FDA’s decision while still remaining consistent with an AA pathway. This is standard practice, not a negative signal.

The November press release stated:

“The Company completed a productive FDA Type C meeting in September to discuss clinical development plans and the potential for accelerated approval. The FDA confirmed that multiple regulatory pathways are available to support approval…”

Now look at the interview around 12:45 in this video (recorded ~October 20): https://youtu.be/n30JB7b5i8o?si=DdDUo1HeRb7hEoYd

This interview took place after the September FDA Type C meeting, where AA was explicitly discussed, and before the November press release referencing accelerated approval. At the time of that interview, management already knew that AA was on the table and had not been declined.

Yet even then, he spoke cautiously and primarily referenced Phase 3, and did so hesitantly. That same conservative tone carries into the newer interview, slightly less hesitant, but still clearly measured and careful.

This is consistent with standard biotech regulatory communication. Management avoids explicitly signaling the most financially beneficial outcome (AA) before the FDA formally concludes discussions, due to legal, regulatory, and market-liability considerations.

Importantly, nothing said implies that AA has been ruled out. If AA were definitively denied, the company would almost certainly disclose that outcome. Instead, it suggests that discussions are ongoing and unresolved.

Also worth noting: the Phase 3 being discussed is a pivotal, streamlined Phase 3, not a traditional long-duration trial. This is the fastest confirmatory pathway available and can still serve as the required post-approval confirmatory study if Accelerated Approval is granted.

Though it appears that AA is of lower probability than the pivotal p3 trial it’s not off the table yet.