A Wall Street Genius's Final Investment Playbook-Chapter 146

“It seems like it will take about a year.”

“A whole year?"

My eyebrows shot up before I even realized it.

It is generally expected that Phase 1 clinical trials take around six months to a year.

But…

“Even with the accelerated approval process?"

Since the introduction of the U.S. FDA Safety and Innovation Act in 2012, the ‘accelerated approval’ system had been gaining traction.

And now, it was 2014.

Even in this peak period of the system's implementation, taking a full year just for Phase 1 was…

Difficult to accept.

Seeing my reaction, David explained the reason with a somber expression.

“Castleman’s disease is an idiopathic condition, and that’s a major obstacle. A surrogate endpoint needs to be designated, but that’s proving to be a significant challenge…”

As I listened to his explanation, the situation slowly became clearer. freeweɓnovēl.coɱ

‘So that’s the issue…?’

The FDA had introduced a streamlined accelerated approval process to address unmet medical needs, and one of its core principles was the use of ‘surrogate endpoints.’

Endpoints serve as a kind of finish line—

In other words, they are the criteria used to determine the completion of a clinical trial.

Typically, endpoints measure things like survival rates, disease recurrence rates, or progression-free survival time.

This is precisely why FDA approval takes nearly a decade.

Clinical trials must continue until symptoms are entirely eliminated.

However, in the accelerated approval process, this endpoint is replaced with a ‘surrogate endpoint.’

Instead of waiting for final results, decisions are made based on intermediate indicators.

For Castleman’s disease, an endpoint could be something like ‘considering the trial successful if CRP (C-reactive protein) levels reach a specific threshold.’

The moment the threshold is met, the trial is deemed successful and concluded, regardless of whether the patient has fully recovered.

However—

“There’s a prevailing opinion that, because Castleman’s disease still has too many unknowns, the surrogate endpoint must be determined with extreme caution.”

Castleman’s is an idiopathic disease—

Meaning, ‘a disease we know nothing about.’

When the exact cause and mechanisms of onset remain unknown, how can one determine a biological marker to serve as an ‘endpoint’?

This must have been an immense burden on the clinical trial designers.

And in the end, they chose the safest approach—

Setting the trial endpoint as close to the final outcome as possible, rather than relying on an uncertain intermediate marker.

“If an arbitrary criterion is set and subsequent trials yield different results, approval could be revoked. That would ultimately lead to an even greater waste of time and money. Moreover, since this is directly related to patient safety, they are opting for a more conservative approach.”

It wasn’t entirely wrong.

Safety should always be the top priority in clinical trials.

But…

‘We don’t have time to waste.’

I already knew that rapamycin would be approved.

With an effective and safe drug at hand, wasting time meticulously checking every step for a ‘just in case’ scenario was unacceptable.

Especially under these circumstances.

“If Phase 1 is delayed like this, Phase 2 will inevitably be delayed as well. That would make our initial goal of gaining approval within three years nearly impossible… And as I mentioned before, if that happens, discovering a second treatment will be virtually out of the question.”

That was the real problem.

I needed to find not one, but two treatments.

To borrow David’s previous analogy, this was like a relay race.

The first runner, rapamycin, had to receive approval before the next runner—the third treatment, the one I truly needed—could even step onto the track.

‘This is a problem.’

“Did they mention the expected duration for Phases 2 and 3?”

“Yes, at the fastest, about eight years.”

I had ten years.

And one of those years had already passed.

Now, out of the remaining nine years, eight would be spent on the first runner?

That was practically a death sentence.

“Then let’s look into contracting a different firm.”

“We’ve already requested quotes from five companies, but they all responded the same way.”

The clinical trial designers were all sticking to the safe path.

They had no incentive to sacrifice safety in favor of speed.

I fell silent for a moment, lost in thought, before finally speaking again.

“Were there any treatments granted accelerated approval last year that targeted idiopathic diseases?”

The intent behind my question was clear.

I wanted to find a precedent for an idiopathic treatment that had already been approved.

The people who designed those trials had already taken the risk of setting uncertain surrogate endpoints, meaning they were more likely to be open to taking on risk compared to other firms.

That meant all I had to do was find them and hire them.

However, even after I said this, David’s expression didn’t brighten.

“There were five cases of idiopathic treatments receiving approval, and of course, we reached out to all of them.”

It seemed he had already considered this option and acted on it.

But judging by his face, the results hadn’t been good.

“All five companies conducted their trial designs internally.”

“And why is that a problem?”

“That means the trial designs weren’t outsourced but handled by in-house personnel.”

“That’s great news. If you’ve identified them, recruiting them should be easy.”

“…Excuse me?”

“Let’s just hire those people. While we’re at it, it’d be beneficial to establish an internal clinical trial design team at RP Solutions. Even if we outsource the execution, having someone in-house to oversee the big picture and direct the process will be a huge advantage.”

“…Excuse me?”

Something felt off about this conversation.

David blinked a few times and gave me a bewildered look, as if to ask, ‘Are you serious?’

So, I responded with a look that clearly said, ‘I don’t see the problem here.’

“Wouldn’t hiring the right person solve this issue easily?”

Our primary challenge was accelerating the clinical trial process.

If that was the goal, then we simply needed to bring in someone who had successfully designed fast-moving trials.

After reiterating this point, David hesitated before responding with a troubled expression.

“That’s not the issue… The people I mentioned all work for major pharmaceutical companies. It’s highly unlikely they would leave a secure position at a large corporation to join a small foundation-backed startup like ours. We can try, but realistically…”

Oh.

That’s what this was about?

I let out a small chuckle.

Looking directly at David, I calmly spoke.

“I think you’ve forgotten something I said before.”

“…What?”

“I told you from the beginning—I intend to solve this problem with money.”

“…….”

For a moment, David’s face went blank.

Then, realization slowly dawned in his eyes.

I nodded, confirming his thoughts.

“Offer them double their current salary. If they refuse, double it again. Keep increasing it until they accept.”

“Until… they accept?”

They don’t want to work for a small startup?

They don’t want to leave a stable position at a major pharmaceutical company?

That just means the price isn’t high enough.

If the offer is right, those concerns will vanish in an instant.

‘I could personally handle this even faster… But for the next six weeks, I won’t even have enough time to sleep.’

Therefore, David had to handle this task personally.

‘Being too frugal can be a problem too.’

The way he insisted on working in a cramped office just to save a few bucks was one thing.

But if my long-term business partner kept handling matters with this kind of mindset, it would become a real issue.

‘I’ll need to have a long conversation about this later…’

But now wasn’t the time for that.

For now, I decided to provide a specific plan.

“Set a time limit and increase the offer step by step. That way, it’ll be resolved quickly.”

“A time limit?”

“At first, offer to double their salary and give them one minute to think about it. If they refuse, quadruple it and give them 30 seconds. If they refuse again, increase it to eight times and give them 15 seconds. Then 16 times for seven seconds, and 32 times for three seconds.”

“Up to… 32 times?”

David’s Adam’s apple bobbed.

He swallowed hard, looking shocked, but I remained calm.

“At most, it won’t exceed ten million dollars a year. If that can cut the clinical trial period by five years, it’s actually a cheap investment.”

Time cannot be bought with money.

That was the common belief.

But this situation was different.

A rare case where time could literally be purchased with money.

‘If hiring this person can reduce the trial duration from eight years to three…’

Then it wouldn’t matter if it cost tens or even hundreds of millions of dollars.

“But still… isn’t that way too expensive? Are you seriously suggesting we offer 32 times their salary?”

Beside David, Jessie looked just as astonished.

She seemed to be asking, ‘Are you really going through with this?’

But money wasn’t the issue here.

“It will be effective.”

“Well, yeah, but… logically…”

David and Jessie turned to Rachel, flustered, as if hoping for her support.

However, Rachel’s face remained completely calm.

“It will work.”

“No, it’s not just about whether it works…”

“I already promised to take full responsibility for financial matters. This is about money, so it’s my decision. Just do as I said.”

And with that, the discussion was settled.

At that moment, a translucent window appeared in my vision.

[Time of Death: March 11, 2023]

[Time Remaining: 3,202 days]

[Survival Rate: 11.9% (+3.1pp)]

***

After spending a night at the Four Seasons in Philadelphia, I boarded a flight to Florida the next day.

This time, it wasn’t some awkward business-class seat arranged by Goldman.

I had purchased a first-class ticket with my own money.

I still wasn’t in a position to fly on a private jet.

So, for now, I had to settle for commercial flights.

I thought first class might be slightly less unpleasant, but…

“Sigh…”

A deep sigh escaped me.

Even first class was far from satisfactory.

No matter how much legroom there was, as long as I had to share a space with other people, there were always distractions.

Passengers whispering two rows away, the captain’s frequent announcements—

[…For your safety, all passengers must remain seated with seat belts fastened…]

Another interruption shattered my peace, sending a sharp headache through my temples.

I tried reclining my seat to rest a little, but…

‘Is this all?’

Even if first-class seats could recline almost flat, they were nothing compared to an actual bed mattress designed for sleeping.

No matter how wide they were, they weren’t as comfortable as a regular sofa.

The only silver lining was that I wouldn’t have to endure this discomfort for long.

The flight time to my destination was just two hours and thirty minutes.

“Sigh…”

Leaning into the uncomfortable seat with my arms crossed, I let my thoughts drift.

I needed to reconsider the meaning of the death notice I had seen yesterday.

‘That was a big jump…’

After the Theranos incident, my survival rate had already risen by 2.5%, reaching 8.8%.

That had been a massive event, a game-changer in securing my position—

And yet, even with all that, the increase had only been 2.5%.

But yesterday… it had risen by 3.1%.

There were two possible reasons.

Either Dylan was an absolutely essential patient for me…

Or the decision to recruit a separate clinical trial designer had a significant impact.

Maybe both.

Whatever the correct answer was, time would reveal it.

For now, I had only one job.

Securing funds.

David’s parting words from yesterday’s meeting echoed in my mind.

—If the accelerated approval process allows us to complete Phase 1 within six months, we’ll immediately move into Phase 2… Will that be okay?

If I succeeded in shortening Phase 1, the next hurdle would appear right away.

One billion dollars for Phase 2, three billion for Phase 3.

Of course, I had the funds.

The Theranos incident alone had secured at least ten billion dollars.

The problem was that it wasn’t my money—

It was investors’ money.

I planned to make a massive investment into RP Solutions.

Four hundred million dollars in six weeks, then a billion in six months.

A total of 1.4 billion dollars—approximately 1.9 trillion won in Korean currency.

But no matter how I framed it as an ‘investment in the future,’ no investor would be thrilled about pouring such enormous sums into a project that wouldn’t generate immediate profit.

Especially if the investment was happening right as the fund launched.

That left only one solution.

‘Diversion.’

I needed to create another event—something to completely capture their attention.

Investors were likely expecting me to pull off another Theranos-level spectacle.

‘Then I’ll meet their expectations.’

I would create an even bigger, more dazzling spectacle—

Something grand enough to completely monopolize their attention.

And in that window of distraction, I would execute the Castleman investment.

Then, by amplifying the diversion event further, I would generate enough returns to cloud their judgment.

So that no matter what decision I made, they would blindly follow.

I had already devised the plan.

Now, all that remained was execution.

Just then, the sharp chime of an announcement cut through the cabin.

[Passengers, we will soon be landing in Miami.]

My destination this time was Miami.

For the next three days, a special event would be taking place there.

The Context Summit.

A prestigious event in the investment and finance world, where hedge fund managers, investors, family offices, pension funds, and asset management firms gathered to network and discuss investment strategies.

The entire financial world would be watching.

Could there be a more perfect stage for diverting attention and steering the narrative?