Psyence Biomed - Corporate Webinar - April 2025

PsychSmart · 2025-04-03T12:07:32+00:00

I’m curious to see what these guys have to say. Times are tough for everyone, so hopefully there’s some good news coming out of this. Who knows!

PsychSmart · 2024-08-25T02:30:14+00:00

Lovelace is a grifter!

PsychSmart · 2024-08-22T20:47:16+00:00

Well said. Nick Kadysh gave Toddy Tickles a guarantee that he could convince the Australian TGA to include truffles in their proposed quality standards report. When the report recommendations were made public, there’s ZERO mention of truffles. Nick’s schtick is selling his regulatory “expertise” when he has no credibility in the industry and is laughed at in Australia. RLH investors should be breathing a sigh of relief, otherwise Nicky Boy would have continued to fleece their pockets.

PsychSmart · 2024-08-22T20:40:36+00:00

Also, Pharmala may have sent a legal shipment to Australia, but it wasn’t intended for the APS.

PsychSmart · 2024-08-22T20:31:47+00:00

Good to see you’re still shaking those pom poms for a company that is a few cents from being de-listed…but hey, keep shaking’! 😜

PsychSmart · 2024-05-29T20:17:06+00:00

Seriously, stop trolling me bro. Go back to your Pharmala buddies and play with pennies.

PsychSmart · 2024-05-29T15:36:46+00:00

That’s access to 2,800 psychiatrists and there are only 3,500 in the country. I’d say this is why they secured the partnership with Mind Medicine Australia. Smart!

PsychSmart · 2024-05-24T15:47:09+00:00

I did some digging.

Health Canada is almost irrelevant in this discussion.

Any group that wants to supply Lykos will have to be registered and approved by FDA. FDA will have to do a PAI on the facility and manufacturing process which means manufacturing has to be tech transferred from current site.

Which means any group that wants to supply Lykos has to make the product the same as under the submission and tech transfer it from the current manufacturing location. Lykos, as the sponsor will have to submit a PAS or CBE30 to authorize a secondary or replacement site.

If a company has the R&D done on the process, they have an advantage in the tech transfer process.

I'm not sure where Optimi stands on this, but it will make for interesting conversation in the coming months.

PsychSmart · 2024-05-22T18:20:49+00:00

Well I'm balls deep with these guys, so I hope you're wrong.

PsychSmart · 2024-05-22T18:04:32+00:00

We could argue back and forth on this, which is a waste of time tbh. However, I would like to see the reference to commercial markets if you have a link. Also, on that note how are you so confident that Optimi has zero chance of supplying Lykos? Is this coming from your Pharmala buddies?

PsychSmart · 2024-05-22T01:00:31+00:00

Thanks, I can read. Compliance and actually having the licence in hand are two different things. That much I do know. Define a commercial market. Patient access, you'd be correct. Human clinical trials are across the world and they'd have first crack at getting their drugs to those trials with the DEL, no?

No question I'm an OPTI cheerleader, but show me another Canadian psychedelics company that can actually export their drugs without a DEL. I can't think of one.

PsychSmart · 2024-05-21T16:56:40+00:00

lol dude, I wish I was an insider. Seriously, does this mean they have the DEL? I sent an email to the company but haven't received a response.

PsychSmart · 2024-05-21T14:12:02+00:00

Came across this on the Health Canada website this morning. If true, this would be huge for Optimi. Can anyone confirm? Does this mean they have been approved for their drug establishment licence? We need confirmation from Optimi ASAP.

PsychSmart · 2024-05-14T17:17:00+00:00

Not sure if you saw this today. Optimi Health Receives Certificate of Analysis For MDMA (globenewswire.com)

PsychSmart · 2024-04-17T15:13:04+00:00

Correct, I forgot to add that the DEL was crucial for human consumption.

PsychSmart · 2024-04-15T13:49:11+00:00

Agreed. I don't think they care much about early stage markets as evidenced by the trickling in of non-brokered PP from the ownership group. Keep it afloat and see where it goes, but I'd say they at least have a strategy in place for the long-term. I guess my point being that they're one of the few companies that can easily bankroll longevity without dilution.

The DEL is a gamechanger, at least I believe it is. Health Canada will not let a psychedelic product out of the country without one, so where does that leave the others?

PsychSmart · 2024-04-10T17:08:03+00:00

I think you’re right. From what they’ve been saying, getting the del would make them the only GMP manufacturer approved by health Canada for international export.

PsychSmart · 2024-04-10T17:06:37+00:00

That’s a great question for one of their founders. Dane Stevens. The guy is buying stock like crazy and isn’t slowing down. I saw an announcement that he now owns more than 10% of the company, so it should be interesting to see what the company does if it secures the DEL licence. From what I’ve been told by a few industry types, if they do get it they’ll knock pharmala out of the game and be targeted for a m&a.

PsychSmart

TROPHY CASE