Will Lantern Bioworks' Treatment be self-certified and the FDA will not contest by EOY 2024?
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278
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resolved Apr 24
Resolved
N/A

See here for more detail: https://www.astralcodexten.com/p/defying-cavity-lantern-bioworks-faq

It can be approved as any type. Resolves YES iff FDA approves. (this has been updated, see below)

Edit:

Scott Alexander says that the process does not involve actual approval.

New resolution criteria: Resolves Yes iff Lantern "self-certifies" and the FDA does not contest.

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N/Aed. See comments for details.

Lol now c an this be naed

@strutheo Hmm, I'm not really sure what to do. I'd be happy to N/A it if a mod confirmed that it does not make sense. But I changed the resolution criteria like on the same day I created it, so I think that it seems fine to me. Waiting for mod input.

@BruhMoment1d78 was a half joke because theyre taking away the power to NA soon, also mods wont tell creators what to do, they will just strongly give their opinion (seemed like a few i talked to think it should be)

@strutheo I see. Lol. If any comment here I will.

@BruhMoment1d78 If this were my market I'd N/A and remake it, yeah.

@Joshua Ok thanks! Will N/A

update from scott

What happened with the FDA testing?

In the original FAQ, I wrote:

Professor Hillman started a company “Oragenics” and applied for FDA approval. The FDA demanded a study of 100 subjects, all of whom had to be “age 18-30, with removable dentures, living alone and far from school zones”. Hillman wasn’t sure there even were 100 young people with dentures, but the FDA wouldn’t budge from requiring this impossible trial. Hillman gave up and switched to other projects.I got this information from (company CEO) Aaron, who says he got it from (original inventor) Jeffrey Hillman.

Commenters (and Kevin Drum) searched publicly-available archives and found a slightly different story, with three trials:

  1. A Phase 1 trial, scheduled April 2005, on 26 people, age <55, with dentures. The company couldn’t find enough people who met enrollment criteria, so they renegotiated with the FDA and switched to (2).

  2. A second attempt at Phase 1 trial, scheduled October 2007, on 10 people, age 18-30, no dentures necessary, done in a hospital setting. This trial succeeded, escalating the process to (3)

  3. A Phase 1b trial, scheduled January 2011. Nobody can find any details on this one, but Oragenics says it never took place because of “the very restrictive study enrollment criteria required by the FDA”.

Some people have tried to argue that someone must be lying, because I wrote about a 100 person trial age 18-30 with dentures, and this doesn’t match either of the two trials we know about.

I think two more likely explanations are:

  • This is Trial 3, the one we know nothing about

  • Or someone in the Dr. Hillman → Aaron → me chain mixed up details of the three trials into a mishmash with some characteristics of each.

@BruhMoment1d78 how do you see self-certification intersecting with approval? FDA approval is an ardous, significant process, and I think a lot of traders acted based on that assumption. I'm also unclear on what "self-certified" means in this case: is it like a homeopathic medication saying "Yo, this solves all health problems* (not approved by the FDA)" or?

I think the ultimate underlying question here is if you're asking whether Lantern Bioworks will be APPROVED BY THE FDA or if the FDA will NOT CONTEST their treatment, and it's best to clarify this earlier rather than later.

If it's the latter, I think you're outwardly asking the wrong question, and perhaps rephrasing along the lines of whether the FDA will block the treatment is more appropriate

@Stralor Okay good point. I am going to resolve as Scott Alexander recommended below. This will resolve YES (as in the description) iff Lantern "self-certifies" and the FDA does not contest.

@BruhMoment1d78 I hope this was clear enough in the description with the EDIT.

@BruhMoment1d78 but this doesnt mean anything... cant anyone just self certify? i dont understand what that means

@strutheo like this market is no longer asking anything, its just saying 'will lantern bioworks eventually sell their treatment in the usa' , which is not the spirit of the original at all. really think this should be NAed after so many title and description changes

@strutheo i def did not notice the comments or description when betting, i thought it was in line with the other FDA markets, probably should have been NAed when scott made that comment

@strutheo the main thing is the FDA not objecting to the self-certification. The resolution criteria haven't changed since Scott's comment (4 months ago); only the title has (to better reflect the criteria). And I hate to say this, but you gotta read the resolution criteria! I made the same mistake but in the other market on FDA approval and just ate the losses.

@agucova the title didnt update to match the description until just recently

@agucova still think this should have been NAed at the start, especially if the title didnt change too

wait this title doesnt match the resolution... feel like it should NA

i bet assuming it was seeking FDA approval, not self certifying

sold Ṁ2 NO

@strutheo i dont think opening preorders counts as FDA approval OR self certifying at any rate.. any anyone selling anything can say theyre self certified then? the question becomes fruitless

@strutheo Sorry for any confusion. I'll resolve to what the mods think is most fair if there is any confusion at time of resolution. See below for context on why I changed the resolution criteria.

bought Ṁ300 YES

Lantern has opened pre-orders in the US, starting on June. https://x.com/lanternbioworks/status/1777843986193056022?s=61

Just a warning: my understanding is that if everything goes well, Lantern will "self-certify" and the FDA will not contest, which doesn't involve actual approval. You might want to rephrase this market to make that clear.

predicted NO

@ScottAlexander Ahh, ok, will rephrase. Thanks!

Would this resolve YES if the "drug" application doesn't pan out and instead they get approved as a "probiotic"?

bought Ṁ15 of NO

@Nikos Yes, that is why I said "it can be approved as any type"

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