Target's subsidiary, Target Medicine, officially submitted an application to the U.S. FDAfor import approval of Luktic's two new drugs.
I had signed a contract with Target stating that Target's pharmaceutical distribution subsidiarywould hold exclusive distribution rights in the United States for five yearsfor both the Skin Regeneration Agent and Elixir.
In return, Target agreed to leverage its influence within the U.S. marketto ensure that the FDA approval process proceeded as smoothly as possible.
The FDA was famous worldwidefor having the strictest and most thorough regulatory review procedures.
In some countries, products approved by the FDA were even exemptfrom additional domestic approval processes—a testament to the agency's immense authority and prestige.
However, the advantages we had been able to securewhen dealing with Korea's MFDScould not be replicated during the FDA approval process.
In Korea, Luktic had been recognized as a promising domestic company,and the President himself had taken a special interest in us—allowing us to benefit from exceptional support and preferential treatment.
That kind of advantage was simply impossible with the FDA.
They would follow procedures strictly, by the book.
That was precisely why receiving support from a major American corporation like Targetduring the approval processwas a tremendous advantage for Luktic.
And that was why we had signed the exclusive supply agreement with them in the first place.
Director Kang Joo-tae, our CTO, explained it to me clearly.
"Approval in Korea does not automatically mean approval in the United States.To sell and use the drugs in the U.S., we must obtain FDA approval separately."
"Director Kang…Are you saying we might need to conduct clinical trials in the U.S. all over again?"
"Not necessarily.If the clinical trials conducted in Korea meet FDA standards,it's possible that the FDA will accept and reference those results as-is.However…"
"…Because our trials in Korea were conducted at an unusually fast pacedue to strong government backing,there's no guarantee the FDA will fully recognize them?"
"Exactly.There are many intertwined variables.Whether the FDA will accept Korea's approval data—especially the clinical trial results.And whether Elixir, which shows outstanding effects against cancer and rare diseases,will qualify for fast-track approval or emergency use authorization in the U.S.All of these factors will determine how quickly approval proceeds."
"In that case…Target's capabilities will be the biggest variable."
"That's right.In complex administrative processes like this,what matters most is how effectively one can respond to constantly emerging variables.And in the U.S., corporate lobbying plays a significant role in administrative procedures."
***
Howard—Head of Overseas Product Planning at Target—was living through a series of breathless, exhausting days.
Since he had personally overseen the entire contract with Luktic,he was now also responsible for directingboth the second shipment of imported productsand the import and approval process for the new drugs.
"Damn it…I'm practically a complete amateur when it comes to pharmaceutical imports.How am I supposed to handle all this?"
Howard stared despairingly at the mountain of FDA manualsand import approval documents stacked across his desk.
He was no stranger to FDA reviewsfor food or health supplement imports—he'd dealt with those countless times.
But directing the import of actual prescription drugswas an entirely different matter.
In the end, he concluded that he would need extensive supportfrom specialists and practitionersworking at Target Medicine,Target's pharmaceutical subsidiary.
After spending several sleepless nights studying the issue,Howard identified two critical factorsthat would determine whether Luktic's new drugscould be imported into the United States smoothly.
Key Variables
1.Would the FDA accept the clinical trial dataconducted in Korea for Luktic's new drugsand proceed with review based on those results?
Or would they reject themand require new clinical trialsconducted in the United States under FDA regulations?
2.Would Elixir and the Skin Regeneration Agent—which showed unparalleled effectsagainst rare and severe diseases—qualify for fast-track approvalor emergency use authorization from the FDA?
Depending on whether these conditions were met,the approval timeline could differby dozens or even hundreds of times.
Muttering to himself, Howard sighed.
"…I'll definitely need expert help.I should coordinate closely with the professionals at Target Medicine."
After nearly a week of overnight meetingswith Target Medicine's specialists,Howard officially initiated the FDA approval processfor the Skin Regeneration Agent and Elixir.
***
Carter visited the hospital again todayto see his ailing father.
His father looked thinner with each passing day.
"Carter… you're here again.You must be busy—there's no need to come so often…"
Once strong and commanding,his father's voice had grown weak and fragile.
"Don't say that, Dad.We finally have hope now."
His father was diagnosed with stage-three pancreatic cancer.
Even surgery offered virtually no chance of recovery.
Because his prognosis was so poor,the doctor gently advised the familyto prepare themselves emotionally.
At first, despair and grief consumed them.
After several weeks passed,they decided to spend what little time remainedas beautifully as possible.
His father had less than half a year to live.
And the final months would be a nightmare—writhing in pain and screamingunless constantly sedated with narcotic painkillers.
That was why Carter resolvedto take his father on tripsto the places he had always wanted to seewhile he was still physically able.
When Carter explained the situation to his company,they readily granted him several weeks of leave—a reflection of the American cultural emphasis on family.
As they prepared for this final journey,a miracle-like piece of news arrived.
A new drug developed in Korea,showing remarkable effects against severe diseases,had received official approval.
And among the diseases it treatedwas pancreatic cancer.
Through a pancreatic cancer patient support group,Carter gathered more detailed information.
Clinical trial results showed that in patientswith the same stage-three diagnosis as his father,metastasized cancer cells were significantly destroyed,and survival rates increased dramatically.
The moment Carter learned this,he collapsed to the floor and wept.
Hope had returnedto a man who had been waiting quietly for death.
He felt nothing but overwhelming gratitudetoward the young Eastern entrepreneurwho had developed such a drug.
Carter looked at his father and said,
"Dad… don't worry anymore.I heard that Target recently submitted an FDA approval applicationto import that new drug."
His father smiled faintly and replied in a weak voice,
"But… will it be approved while I'm still alive…?I don't even have six months left, haha…"
"Don't say that, Dad.Do you know how many pancreatic cancer patients there are in the U.S.?The government will definitely consider people like usand issue emergency approval as fast as possible.The drug has already been approved in Korea.They say when there's precedent in another country,approval in the U.S. becomes much faster."
"I hope you're right, Carter…I'd like to see my grandchildren before I go… haha…"
"Dad, please stay strong.Once you're treated with that drug and get better,I promise I'll have adorable grandchildrenand bring them to see you."
Carter prayed with all his heart.
That the drug would receive FDA approvaland be imported into the U.S.as soon as possible.
***
At the headquarters of the multinational pharmaceutical giant WhiteLily,Chairman White sat with a grave expression.
"Target is attempting to import Luktic's new drugs into the U.S.They've already submitted an FDA import approval application."
Several directors stood before him—the most powerful and influential membersof WhiteLily's executive leadership.
"If Luktic were handling the import themselves,approval would take a long time," one director said."But with Target involved, it's a different story."
"That's right, Chairman.Target already owns a pharmaceutical subsidiary—Target Medicine.If their experts are involved,approval could come much faster than expected."
"And since Elixir shows strong effectsagainst cancer and rare diseases,fast-track approval is not out of the question."
Chairman White pressed his fingers hard against his furrowed brow.
"The moment fast-track approval is granted,our specialized prescription drug sales will take a severe hit.And even now, the Luktic products Target is already sellingare hurting our over-the-counter drug revenue."
"Yes, Chairman.Since Luktic Drink began selling nationwide at Target stores,our OTC drug sales have dropped by over 10%.And that decline continues to accelerate."
"Is there no way to stop this?If this continues, WhiteLily will suffer catastrophic damage…"
At that moment, one director spoke up.
"What if we coordinate with other pharmaceutical companiesto contain Luktic?They must feel the same threat we do."
Chairman White thought for a moment—then nodded.
"Indeed.At this point, everyone may be willingto put aside their rivalriesand unite against Luktic.Prepare meetings with executivesfrom the major pharmaceutical companies."
"Yes, Chairman.Our stock price has already begun to collapse.If we fail to respond properly,we could all be dismissedat the next shareholders' meeting."
WhiteLily was a publicly traded American corporationwith a strict separation between ownership and management.
Chairman White and the directors herewere all professional executives,hired by shareholders.
If stock performance faltered,they could be fired at any time.
Since news brokeabout Luktic's drug approval in Koreaand the FDA application in the U.S.,WhiteLily's stock price had plungedby 30% in just one week.
Other pharmaceutical giants were in similar situations.
A single, overwhelmingly effective new drug—capable of replacing numerous treatments for severe diseases—had instantly priced future lossesinto the entire industry's stock values.
Chairman White spoke tensely.
"Call in every top-tier lobbyist in New York."
***
Luktic began its second shipment to Target.
A long convoy of freight trucksloaded with Luktic Cream and Luktic Drinkstretched toward Busan Port.
I visited the Yangseo County factoryto see the shipment operation in person.
Dong-sik, who had approached my side, said,
"Wow… I still can't believe it, Si-woo.All of that is being exported to the U.S.?Our products are really selling that well over there?"
"Honestly, it still doesn't feel real to me either.But if they're already requesting another shipmentafter the last one,then yeah—it must be selling incredibly well."
"Man… at this rate,Luktic's annual revenue is guaranteedto hit the trillion-won range starting this year."
"That's right.And considering the new factory is only operatingat around 60% capacity,there's still room for far more growth.Building this factory six months agowas truly a masterstroke."
"Heh—don't forgetthat I played a big role in building this factory too."
"Of course, Dong-sik.How could I forget?"
Dong-sik—always bragging playfully whenever he got the chance.
Soon, we would officially announcethe development of the hair-loss treatment.
It would likely cause an uproareven greater than the approval of Elixirand the Skin Regeneration Agent.
Meanwhile, we had already submitted an applicationto the MFDS for approval of the hair-loss treatmentas a modified new drug.
Given the simplified approval pathwayand the government's strong backing,approval was highly likelyto be completed within a few months.
At last—
The miracle medicine humanity had dreamed of.
The hair-loss treatmentwas about to reveal itself to the world.