Theo Jaffee

We're talking about basically progress reform in the Chinese clinical trial space.

The headline here from Kremo is that China is ahead on all of these, has kind of just pulled ahead just recently over the last few years on new drug approvals and particularly on new drug approvals for drugs.

kind of novel clinical targets, which is like, I mean, and the significance here, we can talk about it later, but it seems significant in a bunch of different ways potentially.

The takeaway here is the thing that drove, or at least in part, the thing that drove this change

has been some major process change, some major reform in China about the actual process of running a clinical trial and taking a target through to approval.

And this, I mean, it's good to just, I think it's good to just pick one out.

We can kind of get lost in the detail here, but it sounds like this particular example that you're talking about, Krem, is like, how do things work in the U.S.

?

In the US, you go through a clinical trial.

Throughout that process, you have to provide a bunch of different data and assurances to the regulator.

And I imagine there's a review period for that.

So they say, submit it by this date.

We'll get back to you in 60 days.

oh, you got something wrong.

We'll have another request for information.

That'll take another 90 days to get back to.

So you just have all of these kind of like, kind of stop points in the process of bringing a drug to market.

What you're saying is that the model that China is using right now that they've gone to as part of this reform process is that each, if you're bringing a drug to clinical trial, or if you're bringing these ventures to clinical trial, you kind of keep all of the records throughout the entire process.

You abide by a certain set of standards set by the regulator, but they don't check them

until you reach the final phase three trial.