DFTX: Highlights from the RBC Healthcare Conference

研报英文原文证据摘录

DFTX: Highlights from the RBC Healthcare Conference

d that the 50µg arm was included as a "confounding" dose to preserve blinding integrity: because

the 25µg and 50µg doses were perceptible but showed no benefit in prior work, including a dose arm where pts are told not

to expect effects allows for transparent pbo-like reporting; the primary analysis remains 100µg vs. pbo, even if the 50ug arm

looks similar to 100ug.

• Recall that DT-120 has Breakthrough therapy Designation (BTD) in GAD, and the co indicated that they would likely also seek BTD

in MDD following ph.III data (this seems to be why they did not yet secure a CNPV). If Emerge reads out compellingly, they might

also look to file MDD and GAD simultaneously noting precedent exists for single-trial filings supported by data across indications;

however, mgmt indicated that even a sequential GAD-first/MDD-later path would not meaningfully extend the overall timeline.

• PTSD had always been on the pipeline roadmap, but mgmt noted the recent Trump EO on psychedelics pushed them to accelerate

these efforts.

• Recall that the psychedelics EO also allows for DEA to review drug packages in parallel to FDA review, potentially enabling quicker

timelines (recall DEA pathway is 90-day post-approval review); however, given different state laws, individual roll out within

states is likely to still be the gating factor, though more states have "trigger laws" in place and the co continues to advocate for

these across other states, with some success so far.

• On pre-commercial preparation, mgmt sounded well-prepared to rapidly target the 500-700 high volume Spravato centers (recall

~7K nationwide) and have already begun to build out relationships with those sites; the approach extends beyond sales reps to