Dftx up another 20% after dilution with 5m volume. Cmps not moving as much yet part B around the corner. Help up after public offering.
Am i missing something ?
Anyone planning on joining and can debrief. Would love to hear what former fda staff say
​
The key efficacy numbers:
COMP005: "25% of participants receiving the 25 mg dose had a clinically meaningful benefit at the Week 6 primary endpoint after a single administration, and 40% of those who received a second administration went into remission."
COMP006: "Nearly 40% of participants had a clinically meaningful benefit after receiving two 25 mg doses."
On durability
"For some patients, one or two treatments may have an almost immediate, meaningful and durable benefit out to at least six months."
(Specific percentage at Week 26 not disclosed.)
On functional unblinding :
"A lot of attention has been paid to this issue of unblinding... But it's actually true of all antidepressants and all psychiatric drugs."
On regulatory expectations :
"The regulatory standards for demonstrating evidence of safety, efficacy and quality are no different than for any other psychiatric compounds."
"The usual standards of evidence apply."
On Patient-Reported Outcomes :
"MADRS... doesn't necessarily measure what we've heard from patients is most important, which is quality of life and level of function as opposed to the symptom reduction."
Good watch.
depsite having been deep in the rabit hole since jan 25. i learned a lot reading this piece which author was highlighted by u/therealseba !
CMPS unknowns 👀
The five variables Borecky says will decide everything
few extracts to peak your interest :
Compass’s Phase 3 retained the one-to-one Certified Psilocybin Session Monitor structure that the FDA’s guidance treats as an uncharacterized variable; the company is now attempting to translate that trial architecture into a lighter commercial model.
BPL-003 excluded prior non-response to ketamine, esketamine, ECT, VNS, or DBS, which excludes the patients for whom every prior interventional option has already failed [21]
The trial tells you what the drug does in a population the drug will struggle to reach.
Consider the modal patient who sits in an interventional psychiatry clinic after two or three failed SSRI trials. She is sixty-something. She is on 25 mg of sertraline, a dose her primary care physician started her on four years ago and never titrated; her daughter is on the same medication at the same dose. She has heard of ketamine, has strong opinions about it, and is not sure whether those opinions would survive her reading the label carefully. She has not heard of Spravato. She has not heard of COMP360 by name. She has heard of 5-MeO-DMT exactly once, on a podcast her adult son sent her, and what she heard was enough to make her decline the conversation before it began.
She is not the exception in the clinic. She is the modal TRD patient. The likelihood that such a patient consents to inhale a drug whose cultural footprint consists of Tyson, Pollan, Johnson, Town & Country, and a set of recent federal headlines drops sharply relative to her likelihood of consenting to a ketamine infusion, and drops further still relative to her likelihood of accepting a fifth oral antidepressant. Multiply her across a practice and the constraint becomes visible. The infrastructure constraint is real. The recruitment constraint is upstream of it.
Compass’s 3.8-point MADRS delta looks modest until the question becomes who it applies to. COMP360’s Phase 2b enrolled 6% of its patients with prior psychedelic experience, the lowest proportion of any modern psychedelic TRD trial; [11] its cohort is more naive, more representative of the average TRD patient’s cultural distance from the drug class. The six-hour session with a therapist in the room is operationally worse on every AtaiBeckley slide. It is also the model that can absorb a patient who would otherwise never consent.
A model that maximizes per-room throughput is not necessarily the model that maximizes treated patients.
The reader who sees only the short-acting elegance is missing the denominator. The reader who sees only the denominator is missing what the short-acting architecture genuinely solves.
The model that produces the cleanest trial result is not necessarily the model that treats the most patients.
The patient who will decide which bet was right exists in every interventional psychiatry practice. She is on a submaximal dose of an SSRI her daughter also takes. She has heard things about 5-MeO-DMT from her son’s podcast, none of them reassuring.
The spreadsheet does not see her. The clinician who might prescribe the drug does.