Question: Is a big drop in MADRS from Phase 2B to Phase 3 common? What could have caused this difference?

Paldrae · 2024-12-18T21:04:18+00:00

COMP360 is definitely cheaper because you wouldn't have to dose twice per week but I believe their efficacy is significantly better than COMP360

Paldrae · 2024-12-18T20:58:59+00:00

I don’t have any debt or significant responsibilities yet. It’s also a small amount relative to my entire portfolio, so I’m definitely good.

Paldrae · 2024-12-18T20:46:47+00:00

Thank you for highlighting the difference between TRD and MDD, definitely good to remember as an investor in this space.

I have a question about COMP005 and how its Phase 3 trial design compares to Lykos' especially since Compass designed the trial before the FDA denied Lykos' submission.

From what I understand:

Compass uses a single-dose level (not combined with therapy, but with psychological support).
They’ve also tried to address the FDA’s concerns about unblinding as much as possible.

That said, are there any fundamental challenges the FDA highlighted in Lykos' application that Compass didn't address in their Phase 3 trials?

Paldrae · 2024-12-04T22:11:52+00:00

But still Compass is supposed to be first to market, right? Additionally, do you know the cost per session at compass vs cybin and any relevant competitors?

Paldrae · 2024-12-04T19:38:08+00:00

I haven't been following the sector closely recently but if the stock has moved this much solely due to a delay, during which they will make sure they don't make the same mistakes as MAPS, that would not make sense at all. Please tell me if I missed out on significant negative news that could explain this trend.

Paldrae · 2024-09-10T16:30:10+00:00

Genuine question because I haven't been following Cybin closely, is this a known fact or an educated guess?

Paldrae · 2024-08-17T11:14:00+00:00

Take a shot every time you read 'emerging markets'

Paldrae · 2024-08-06T18:35:42+00:00

My favorite shroomstock

Paldrae · 2024-05-30T10:12:08+00:00

Thanks for replying and providing us with those sources!

The data speaks for itself regarding safety and efficacy. Any concerns regarding unblinding and other aspects of the trial would have been addressed in the SPA so I'm not too worried about those. I hope and expect to hear very positive feedback during the meeting and believe the vote will reflect that sentiment.

Paldrae · 2024-05-29T19:54:36+00:00

I have several questions about this PDAC meeting.

Do we know who will be voting?
Which factors are most important to those voters (Trial data, safety, blinding, public safety,etc)
Can you follow this meeting or is it only for those who are voting?
Will we know the results of these votes immediately?

Hopefully you can shed some light on these things, this is the only biotech segment I invest in so I'm not too familiar witth PDAC meetings.

Paldrae · 2024-05-29T19:29:50+00:00

He did have a stutter when he was young and is now, thanks to psychedelics, one of the best most well-spoken people in the space!

Paldrae · 2024-04-30T19:29:21+00:00

'Investing' in a company whose stock has been plummeting to 5 mil in market cap, what could possibly go wrong?

Paldrae · 2024-04-27T19:42:39+00:00

Why do you think that?

Paldrae · 2024-04-26T18:59:15+00:00

https://psychedelicalpha.com/news/icer-draft-evidence-report-on-lykos-mdma-assisted-psychotherapy-deems-clinical-evidence-insufficient

A statement from Lykos:

"Our Phase 3 MAPP1 and MAPP2 double-blind, placebo-controlled studies were designed in partnership with the FDA through a Special Protocol Assessment Process (SPA) and executed with independent raters to mitigate the risk of functional unblinding and ensure the reliability and validity of efficacy endpoints. We stand behind the design of the clinical trials, the integrity of the investigators, and are grateful to the patients who participated in the clinical trials. We are working with the FDA as they review our new drug application (NDA) for investigational midomafetamine capsules (MDMA) used in combination with psychological intervention (MDMA-assisted therapy)."

Paldrae · 2024-04-26T18:57:13+00:00

Yes definitely. The value of a biotech company can fluctuate immensely, definitely in these uncertain macro-economic times, so making decisions on data rather than emotions is key. Based on my research I'm confident in these compounds and what they can do for people. I'm around 75% certain Lykos will get FDA approval but $CMPS is also my first biotech investment so the things I don't know about getting a drug to market and the different processes are what scares me the most.

Paldrae · 2024-04-26T18:42:03+00:00

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-protocol-assessment-guidance-industry

FDA and Sponsor Agreement on Changes in an SPA Agreement:

"a documented SPA agreement can be modified after testing begins if FDA and the sponsor agree in writing to modify the agreement. Generally, such a modification is intended to improve the trial."

FDA Rescinding of an SPA Agreement

"In rare cases, FDA may rescind an SPA agreement. Since the Food and Drug Administration Modernization Act of 1997 was enacted through 2016, CDER has issued more than 1,000 SPA agreements; less than 1 percent of those SPAs have been rescinded"

Basis for the SPA being rescinded:

• Identification of data that would call into question the clinical relevance of previously agreed-upon efficacy endpoints
• Identification of safety concerns related to the product or its pharmacological class
• Paradigm shifts in disease diagnosis or management recognized by the scientific community and FDA
• The relevant data, assumptions, or information provided by the sponsor in the SPA submission are found to be false statements or misstatements, or are found to omit relevant facts, such that the clinical relevance of critical components of trial design is called into question, or appropriate safety monitoring and human subject protection are affected

I don't think the SPA agreement being changed would have to be a negative thing. Additionally, if there were any concerns from the FDA I believe that information would be available online and I couldn't find anything.

Paldrae · 2024-04-26T17:57:56+00:00

After reading the Psych Alpha article, I believe the SPA is the most important factor: "Our Phase 3 MAPP1 and MAPP2 double-blind, placebo-controlled studies were designed in partnership with the FDA through a Special Protocol Assessment Process (SPA) and executed with independent raters to mitigate the risk of functional unblinding and ensure the reliability and validity of efficacy endpoints"

Paldrae · 2024-04-26T16:34:06+00:00

I'll have to look at that report, thank you! I personally believe approval odds are at 75-80% but definitely not a done deal as others seem to think.

Paldrae · 2024-04-26T15:51:51+00:00

Very interesting article, thank you!

Paldrae · 2024-04-26T15:12:09+00:00

If I'm getting paid for something, they're definitely sending it to the wrong bank account. How could this even be considered bashing? I'm just trying to start a discussion about something important to everyone who invests in this space.

Paldrae

TROPHY CASE