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CH56 | DI
🕑 Added 2025-03-16 03:00:04 +0000 UTC“This is a requirement from the FDA. Proof of financial ability to complete the clinical trial to the end is essential….”
To start a clinical trial, secure the necessary budget first and then begin.
The condition set by the FDA is reasonable.
If funding runs out mid-trial, forcing a premature end, it would be a disappointment to the participating patients.
“How about a partnership with the pharmaceutical company?”
“Unfortunately, it’s not very likely. I asked Kaize, who owns rapamycin, and they started talking about licensing agreements right away.”
Far from discussing a partnership, they brought up the issue of usage fees.
“If we can’t proceed with the pharmaceutical company jointly, we need to raise the entire $400 million ourselves. That’s quite unreasonable…”
“Is there no way to reduce the costs?”
“It’s going to be difficult. The basic operational costs are enormous...?
If major pharmaceutical companies do not join the research, the Castleman Foundation has to conduct the clinical trial alone.
Then, things get complicated.
From designing the trial, searching for participating hospitals, communicating with staff from various institutions, to collecting and analyzing data…
There were numerous costly items.
It was when I was coordinating the details with David.
Ring—
The phone rang.
The caller ID showed it was Dobby.
[Where are you? Pierce is looking for you?]
I am still working as an analyst for Goldman. Managing a shady fund and the Castleman Foundation are just side jobs, my main job is here.
I had to wrap up with David urgently, and returned to my main duties, finishing the day’s work when it was already midnight.
It’s about time for the death notification to arrive.
‘Please……’
Although always treated as an unwelcome guest, today was different.
Looking forward with anticipation, a familiar window popped up.
【Death Date: March 11, 2023】
【Remaining Time: 3,329 days】
【Survival Rate: 6.1% (+2.3pp)】
As expected, it increased.
The survival rate, previously only 3.8%, had surpassed 6%.
This change occurred after finalizing a new plan with David.
Even without implementation, the figures had risen.
If the right direction is set, it immediately reflects in the numbers.
And the current figure suggests that the new plan I devised is correct.
Meaning, clinical trials on rapamycin must be conducted within three years.
‘By the end of the year, $400 million……’
That’s the amount of funds I need to raise.
Honestly, it’s not that difficult.
Just quadruple the $100 million I currently hold.
2014 is when the biotech boom began.
All the top performers in my memory went on to record returns of over 300%.
Just by placing them in such stocks, $400 million will be filled on its own.
Does it seem too easy?
Yes, it’s easy.
The problem is what comes next.
‘This would deplete the seed money…’
If I withdraw the entire $400 million by the end of the year, I’d be left penniless.
My funds would evaporate and I’d have to start from zero again.
Of course, it wouldn’t be a complete reset.
I can still take fees from the funds of shady investors.
‘So, should I somehow prevent redemptions……?’
Gerard, Judy, and Ferguson.
The money they entrusted has ballooned to $150 million.
If I manage it to yield 300% and take half, I could salvage about $300 million.
However.
The necessary period for that is one year.
I need to hold them for at least a year to realize that profit.
“Sigh….”
A sigh escapes me naturally.
Until just yesterday, my pockets were full and I had no regrets, but overnight, it’s come to a point where I might have to cling to Gerard’s coattails.
As I let out a frustrated breath, Dobby’s face suddenly appeared over the cubicle.
“What’s up, have you seen the news?”
“News?”
“Huh? You haven’t seen it? This, look at this!”
Excited, Dobby shoved his smartphone screen in front of me.
There was an article prominently displayed.
<Genesis, Planning PBC Trial. Discussing Accelerated Approval with FDA>
It’s a follow-up article about Genesis’s new drug OCA. But the moment I saw it, I felt strange.
A chilling sensation in the corner of my heart.
‘Why?’
The reason was unclear.
But as soon as I saw this article, an ominous premonition overwhelmed me instinctively.
I took the screen and carefully read through the article.
‘There’s nothing much….’
The news was about Genesis expanding the indications for OCA.
From the existing NASH to a rare disease called primary biliary cholangitis (PBC).
The reason Genesis is showing this move is one.
They’re aiming for accelerated approval.
Rare diseases allow for a simplified process, enabling quicker authorization.
Dobby peered at my expression from the side and asked.
“So, does this miss your prediction? You said it would take 10 years for approval, didn’t you? Seems possible within 5 years now, right?”
In truth, even 5 years might not be necessary.
OCA would eventually get approved in 2016, but only for the rare disease PBC.
I responded to Dobby in a calm tone.
“Even if it gets approved, the stock price will hover around $400. The key is expanding into the NASH market.”
“But they say the cholesterol side effects aren’t severe? The stock has already recovered to 300.”
“I don’t know.”
“Why, is there something else?”
“You can’t be sure it’s just cholesterol.”
The real danger of OCA isn’t a change in cholesterol levels.
It’s liver damage.
By 2017, the first death due to liver damage would occur.
However, the stock price wouldn’t plummet immediately.
The cause of the patient’s death was due to overdose, not a defect in the drug itself.
The FDA considered it a misfortune caused by the user’s error.
Such an incident could not discard a promising new drug.
So they wrapped it up by demanding a change in packaging.
They required warnings on the product like ‘Serious side effects (death) can occur from overdose.’
But the tragedy did not stop there.
After over twenty more victims followed, the FDA could no longer stand by.
In 2020, the FDA took a tough stance.
They restricted the use of OCA to rare diseases, and outright denied its expansion into the jackpot, NASH.
That’s when Genesis’s stock price plummeted.
Dreaming of an El Dorado called NASH and riding a rollercoaster, all hope was dashed, crashing down by 90%.
“Sigh….”
When I remembered up to this point, frustration surged.
Suddenly, a sense of anxiety as if I couldn’t breathe properly attacked me.
There shouldn’t be anything wrong with my respiratory system…
But strangely, it feels like there’s not enough air.
Before regression, when I used money on strange things, I often had these symptoms…
‘Could it be…… a panic attack?’
This is definitely a sign of a mild panic attack.
So it’s even more perplexing.
There’s no reason for me to fall into panic after seeing Genesis’s article.
‘Because I know that a fatal accident will happen in the future?’
I’m the only one who knows this tragedy at the present time.
Do I feel some responsibility for it?
No, after all, side effects are recognized only when they actually occur.
No matter how much I warn about the dangers of OCA, everyone will only move after an actual death occurs.
There’s nothing I can do with my own hands.
Then, there’s only one thing I can do.
‘Short selling.’
In 2020, a huge opportunity for shorting arrives.
In fact, the reason I pulled out of Genesis was because of this.
No need to fret over small fluctuations; just aim for that one big hit.
“Sigh…….”
But thinking about shorting makes my breathing even faster.
Now my hands and feet are ice cold.
Could it be, do I feel guilty for making money off this tragedy?
No, that’s nonsense too.
I’m not pushing anyone towards death.
It’s just making some money off an event that was bound to happen anyway.
Emotions have no place in investing.
Especially since I’m not exactly the type with a highly developed conscience.
If anything, quite the opposite.
Yet…
An inexplicable anxiety is constricting my heart.
‘Why?’
Because of this bizarre anxiety that won’t let me go, I was holding onto the Genesis article for a long time.
‘No, wait.’
Suddenly, a realization came to me.
What wasn’t visible in a previous life, in this life, was clearly visible.
The identities of those who died from OCA.
The deceased…… were all patients with severely impaired liver function.
They had died as a result of taking doses far exceeding what the FDA recommended.
Even though the label on the product clearly warned that overdose could lead to death, the deceased had ignored this warning and ingested lethal doses of the medication.
Why did they make such a choice?
There’s only one reason.
‘These people too…..’
Were playing Russian roulette.
For patients with severe liver damage, there’s only one treatment.
Transplant surgery.
But, transplant surgery isn’t something you can have just because you want it.
It requires a donated organ, and there are conditions attached to this.
Those with a history of alcohol addiction, the elderly, or those with accompanying diseases are deemed unfit.
For these people, the path to organ transplantation is completely blocked.
Then, for those who were just lying in bed waiting for death, news of a miraculous treatment comes along.
It’s Genesis’s new drug, OCA.
OCA significantly reduces the bile accumulating in the liver by affecting the gene expression needed for bile production and transport.
Its efficacy has already been proven.
It’s effective enough to pass if it were only half tested.
However, anything excessive is not good.
OCA was so effective that it suddenly altered the liver’s metabolism, leading to death as a side effect.
In a way, OCA is a double-edged sword.
The effect is certain, but if a certain line is crossed, it results in death.
No one knows exactly where this dangerous boundary lies.
What if, we find that appropriate line?
Enjoying the maximum effect of the drug while avoiding its side effects—finding that last line of defense.
Of course, failure means death is waiting.
But for the patients, it probably didn’t matter.
Since they were patients for whom transplantation was not an option, they were already facing death.
Maybe they chose to gamble with dangerous odds rather than certain death.
It’s clear.
Otherwise, there would be no reason to deliberately overdose on a medication labeled ‘death from overdose.’
The victims of OCA were playing Russian roulette.
Exactly what David and I are doing.
‘So what.’
I might feel sympathy as I am in the same situation, but it’s strange that I feel this anxiety.
However, I soon found the reason for it.
‘The timeline has changed.’
OCA is a real case of Russian roulette.
Then, how the FDA responds to this is an important clue for us.
It shows how the FDA deals with Russian roulette.
In 2017, they observed the situation.
But by 2020, they had turned to a tough response.
If that’s the case again...
If we attempt Russian roulette in 2020 when the FDA adopts a tough stance, there’s a high chance of being caught from the start.
It would be wiser to start in 2017, before the FDA realizes the true nature of this dangerous gamble.
The moment I realized this fact.
“Sigh…….”
A sigh of relief naturally escaped, and even a chuckle followed.
“If I hadn’t seen this…”
It could have been a real disaster.
Thanks to this strange anxiety, I managed to capture an important fact that I could have overlooked.
Now that I think about it, the strange symptoms that had enveloped my body until just moments ago have completely subsided.
“Maybe…….”
I think I now understand why the anxiety I felt earlier was so similar to the symptoms I had experienced in a past life.
The symptoms that no psychiatrist could ever diagnose the cause of…
It was only on the brink of death that I could finally understand the true nature of those symptoms.
It was a warning signal sent by my own cells.
A signal that I must not settle for the present to survive…
That was what my own body was screaming.
I know.
It sounds absurd.
It’s a completely unrealistic interpretation.
But if we’re being honest, the chance I have and the situation of having returned to the past also have zero reality.
This anxiety symptom is a kind of signal.
A signal indicating a risk factor that I am overlooking.
I must continue to listen to this signal going forward.
This is quite encouraging news.
It’s like having a kind of alarm system that automatically detects risks I’m unaware of.
While I was encouraged by this realization, an even more welcome piece of news arrived.
I received this text from Gerard.
[Can you make time this Sunday?]
It was a request for a meeting.
However, the place Gerard specified for the meeting was extraordinary.
Right on Fifth Avenue, at the Metropolitan Club.
It seems the moment I’ve been waiting for has finally arrived.
It’s time to meet Rachel and Gerard’s father.
