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9 results for “regulatory approval”
of the regulatory risk. And, candidly, it made it really easy for them the diligence. Right? If I said, look at this data. This data means we're gonna get efficacy approval. Your average generalist investor cannot underwrite that. Right? They can't c
9:36 / 10:52
from transcript9:36 – 10:52
in order to get regulatory approval for aging and now just to take a step back. No drug to date has been approved for aging. Yeah. Not one. Not by any of the regulators. Not your metformin, not your rapamycin, not any of the GLP ones. So how do you g
26:10 / 27:19
from transcript26:10 – 27:19
call it excess regulatory burden that's causing these extended timelines on drug approvals. Just just to kind of frame it up a little bit. Sure. So there's an something called the IND, investigational new drug registration process. That's step one. M
13:29 / 14:30
from transcript13:29 – 14:30
...it excess regulatory burden that's causing these extended timelines on drug approvals. Just just to kind of frame it up a little bit. Sure. So there's an something called the IND, investigational new drug registration process. That's step one. Most o
12:39 / 13:53
from transcript12:39 – 13:53
...approval process is through like huge strategy. I think it was the drug, salidamide, that pregnant women were taking that led to number of deformities in kids that were being born from those pregnant women. And since then, FDA started to require not
7:21 / 8:38
from transcript7:21 – 8:38
...of the regulatory risk. And, candidly, it made it really easy for them the diligence. Right? If I said, look at this data. This data means we're gonna get efficacy approval. Your average generalist investor cannot underwrite that. Right? They can't c
8:59 / 10:05
from transcript8:59 – 10:05
...approval process. And, yeah, whoever would come to FDA to deregulate this process would have to take on, like, in a way, enormous personal risk because regulation is a tension between safety and efficacy. And if we deregulate process, we would have t
8:13 / 9:15
from transcript8:13 – 9:15
...in regulatory regimes play into here? Because one thing we often hear when it comes to outsourcing manufacturing to China, whether it's something basic like, I don't know, clothing or something more advanced like medicines, is that it's cheaper to ma
20:13 / 21:17
from transcript20:13 – 21:17
Really hard. Can I tell you an interesting Please? So in The US, we run three phases of clinical trials. Clinical trials. Right? Phase one to test for safety and healthy volunteers. Phase two to test for efficacy to see if the drug actually works in
1:21:00 / 1:22:04
from transcript1:21:00 – 1:22:04
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