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by marcelsalathe 769 days ago
I'm a bit puzzled why one would hold a press conference for a trial that hasn't happened yet - especially as this seems to be a phase 1 trial to test safety in humans.

The development of medical interventions typically goes through a number of stages.

The earliest stage is called the pre-clinical phase, where a candidate intervention is tested outside of humans, either in vitro or in animals. The images of the mouse and ferret teeth suggest this has been done.

Phase 1 is when the intervention is first tested in humans, typically in small groups of usually dozens of participants. The aim here is not to evaluate efficacy - phase 1 studies are often too small for that - but to assess tolerability and safety, and to find the optimal dosing with respect to side effects.

If an intervention appears safe in certain doses, it can then be evaluated for initial efficacy and continued safety in a phase 2 trial, which is larger (usually hundreds of participants). Think of it as a kind of pilot trial to see if the intervention has the desired beneficial effects without serious negative side effects, and to identify the dose with the best benefit/risk ratio. About half of the studies get past this stage.

Those that do can enter phase 3, which is the full efficacy and safety assessment of the intervention. Again, about half of the phase 3 trials eventually make it to market. Of course, the intervention first needs to go to the health authorities for regulatory approval before it can be offered on the market.

For an interesting study on costs during these phases, see e.g. https://pubmed.ncbi.nlm.nih.gov/32125404/

I'm obviously very excited about medical progress but if we had a press conference for every planned phase 1 trial we wouldn't be doing much else ;-)

3 comments

> I'm a bit puzzled why one would hold a press conference for a trial that hasn't happened yet

This is something Japan loves to do. We joked during covid that they kept making announcements that they were planning to have a meetings to prepare announcements.

Ironic there is so much red tape yet having original ideas are still frowned upon.
I you live long enough in Japan this is just concept as viewed by an outsider. Their dollar store is full of almost useless ideas put out in the market. Even the blue LED was discovered because a company owner invested millions and his scientist was not afraid to try new ideas. You will find all sorts of camera styles on their electronic stores. Even their appliances have all kind of categories and you wont see the west even trying to put it out in the market.
Meh. My experience working there wasn't so much that original ideas were frowned upon as much as thinking/saying you're better than your group-mates for having them was. It's a subtle difference, but I saw plenty of novel ideas take root, but only after an excruciatingly long period of socialization. In the states and in most of Europe, it seems if you have a good idea, you just blurt it out and people say "hunh. that sounds like a good idea. let's do that thing." But Japan and Sweden required A LOT of planning and hemming and hawing about whether the new idea was a good thing to do.
What you’re referring to is called nemawashi in Japan , literally “digging around the roots of a tree”. It’s formal business etiquette understood by all office workers. One shouldn’t blurt out ideas to an unprepared group, but spread the idea around before especially to the superior. If they reject the idea they don’t have to embarrass you in front of others, or lose face in public for being taken by surprise.
In the states and in most of Europe, it seems if you have a good idea, you just blurt it out and people say "hunh. that sounds like a good idea. let's do that thing."

It might vary from company to company, but I find the response is more “you should do that thing”. People are too busy with their own ideas to waste time building yours.

Biotech companies go public incredibly early compared to tech not sure if these guys have yet but it would have a huge impact on their stock price and likely hold of getting into conversation with a major pharma Co that can pay for the later trials
This is the correct answer. Biotech VCs invest very large amounts based on early scientific results and the vast majority of biotech companies go public before they even have revenue because they can't legally charge a penny until regulatory approval. This is how the pharmaceutical has been offloading their increasing R&D expenses onto the public since the patent cliff picked up speed in the 1990s.

A major PR push exposes them to as many investors as fast as possible both at the VC and public level. When the science is particularly solid, this process can happen fast and involve ridiculous amounts of money (i.e Sofosbuvir discovered 2007, first tested 2010, bought for $11 billion in 2011, approved 2013).

I assumed it’s to drive up interest among potential investors.