Dear Reader,
T.G.I.F.!
While we’ve been focused on geopolitics this week due to events in the Middle East, there’s been a quiet revolution happening at the FDA thanks to RFK Jr.’s initiatives.
It’s kind of been like “AI month” at the FDA.
That’s what I want to talk about today.
On June 2nd, the FDA launched an agency-wide AI tool named Elsa, to optimize performance.
The agency is going to be using Elsa to accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high priority inspection targets.
Basically, they want to speed up the drug development process.
Then, on June 17th, the FDA announced a national priority voucher program.
This is a big deal.
The new voucher may be redeemed by drug developers to participate in a novel program where the FDA shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission.
RFK Jr. is shortening the timeline, speeding up the movement.
Notably, both of these announcements came by saying, we’ve integrated Elsa into the FDA and we did it on time and under budget.
I love that.
That’s one of the things I love about the Republican party…
We’re proud of doing things on time and under budget.
What we see happening here, after first focusing on the breaking and the dismantling of the old way of doing things, we’re now starting to see the whole picture come into focus…
And it’s really just getting rid of government and unleashing American companies…
Unleashing the drug discovery process, which is very, very exciting.
The biggest change in the works right now is a new law that’s working its way through Congress with bipartisan support.
It’s known as the FDA Modernization Act.
This is one of the big centerpieces of the MAHA movement - make America healthy again.
It’s called H.R. 7248.
It’s a bill that replaces animal testing with AI testing.
As this really starts to wind its way through, it has a lot of implications.
Here’s where it gets very, very interesting…
Right now, the way companies test…
Before human clinical tests, they test rats, monkeys, etc.
They put these drugs in animals and see what happens.
That’s a very time and labor intensive, costly process.
The science may have been appropriate for the 19th and 20th centuries, but it’s primitive compared to the tools we have now.
So basically, we’re going to be ditching animal testing for AI testing.
And here’s where it gets interesting…
There are 6,653 firms in the U.S. that could be forced to replace animal testing with AI testing.
We weren’t planning to have a webinar this month, but this news is too important to ignore, and too urgent to wait on...
AI is THE trade of this decade, and this is the first time in history a cutting-edge technology is being federally mandated.
And unlike all the AI companies you’ve likely heard of (you know, the ones trading at all-time highs)...
The AI firms that will benefit from this federal mandate are in a hated sector that’s been beaten down all year.
The urgency here is that this mandate could go into effect as soon as June 27th. If we don’t position ourselves before then, it could be too late.
So we’ve cleared our calendars to meet with members for a one-hour briefing on this time-sensitive situation this-coming Tuesday, June 24th at 1:00pm Eastern time.
We’ll walk you through what this mandate means…
All the research we’ve been putting together since the announcement was made…
And the top AI companies already positioned to lead the initiative.
Because look, there are as many as 6,653 firms in the U.S. that might be forced to replace animal testing with AI testing, starting with an announcement coming as soon as June 27th.
There are little-known players leading this space right now that we need to talk about - backed by smart investors like Bill Gates and NVIDIA.
Those 6,653 firms could be forced to turn to these companies for all their simulation models and testing. And it could happen as soon as next week.
There’s little time left to take action.
We need to talk about what it really means to modernize the FDA in this way.
It’s going to create hundreds, thousands, of customers worldwide for firms that provide this solution.
This is a real event. It’s happening. And it’s a BIG, BIG DEAL.
This is worth talking about.
Please join us.
Here is your private link to RSVP.
It’s going to be fun.
We’ve done a LOT of research the past few weeks. We’ve done our homework.
You won’t want to miss this.
If you missed the biggest gains in NVIDIA…
Or the big gains we were able to show readers on Palantir…
This is a rare second chance to invest in the biggest AI story you haven’t already heard.
So again, that is this-coming Tuesday, June 24th at 1:00 Eastern. I hope you’ll join us.
Simply click here to let us know you’ll be there, and we’ll send you your private link to join.
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