The Magician’s Memorial - Chapter 409
Only Noblemtl
409. Good misunderstanding (4)
Centrian was a melting pot of festivities.
The researchers who succeeded in developing a MERS treatment in a short period of time were enjoying a break and joy for the first time in a long time.
“Congratulations!”
“Thanks to the Chairman, we were able to develop a MERS treatment so quickly. Of course, we have only passed the first clinical trial, but the results were very good.”
Dr. Jangwoo Kim’s voice was cracked.
He provided room and board in a laboratory to develop a treatment for MERS, and did not hesitate to work overnight.
“This achievement was possible thanks to the doctor and researchers.”
“Actually, we didn’t do much. The data on the SARS treatment developed by an American pharmaceutical company was very helpful. It would have been impossible if we started from nothing, but it was possible because we had a reference book on the SARS treatment.”
This was David’s ball.
An American pharmaceutical company said it would sell SARS treatment for $100 million.
David, with his greed, reduced the price by as much as 50% and purchased the treatment for only $50 million.
Of course, $50 million was by no means a small amount.
If a MERS treatment could be made in a short period of time, it would be worth the price.
“When can a cure be released?”
“Clinical trials are conducted in four stages. We have only completed stage one. And no matter how quickly we move, it will take quite some time to release a treatment because we have to follow the Ministry of Food and Drug Safety’s schedule. At the earliest, a treatment will not be available until after this year. can.”
All keys were held by the Ministry of Food and Drug Safety.
It is not for nothing that in the United States there is extensive lobbying on ministries such as the Ministry of Food and Drug Safety.
If the Ministry of Food and Drug Safety was late, the launch of new drugs would inevitably be delayed.
In the pharmaceutical industry, the Ministry of Food and Drug Safety was said to be the best.
However, the Ministry of Food and Drug Safety was ultimately nothing more than a government department, and it was in a position of inferiority in front of the Blue House.
“The MERS treatment could be released within the next month.”
“Is that possible?”
“The one in most urgent need right now is not us, but the Blue House. Our approval ratings are falling rapidly due to the MERS outbreak. A MERS treatment will be essential for our approval ratings to rebound.”
There was no need to lobby the Ministry of Food and Drug Safety or the Blue House.
From the beginning, there was no intention to make money with the MERS treatment, and it was just a cornerstone for developing a treatment for COVID-19.
However, the Blue House’s position was different.
A cure must come out quickly so that we can overcome the current situation.
“If the Blue House takes an active role, the Ministry of Food and Drug Safety will move quickly. However, the clinical trial stage cannot be reduced.”
“That will depend on how urgently the Blue House views this situation.”
I paused the conversation for a moment, picked up my cell phone, and called the planning director.
“Inform the Blue House that we have succeeded in developing a MERS treatment. However, also inform them that due to the Ministry of Food and Drug Safety’s clinical trial stage, the treatment will not be released until next year.”
[I will deliver it right away.]
Taewoo Group’s planning director had several hotlines.
One of them was a hotline that could connect with the head of the Blue House.
In particular, after Taewoo Hospital decided to take full charge of the MERS outbreak, constant contact with higher-ranking officials became possible.
* * *
two days later.
I was watching breaking news with a vice president.
It was breaking news that showed how seriously the Blue House views the Messr incident.
[The Ministry of Food and Drug Safety has introduced an emergency use approval system for MERS treatment. This is a system that reduces the complex clinical trial stages and allows treatments to be released as quickly as possible. This is a system used by the US FDA, but was introduced for the first time in Korea.]
I burst out laughing at the breaking news.
Vice Chairman Han could not keep his mouth shut, as if he could not believe the current situation.
“It seems like the Blue House really made up its mind. I never even expected to introduce an emergency use authorization system.”
“The approval rating has fallen so much that something needs to be done. Of course, just because the emergency use approval system has been introduced, we cannot launch a MERS treatment right now. It is just that the clinical trial stage has been reduced from stage 4 to stage 3.”
The government’s approval rating fell to 29%.
As the approval rating fell, the Blue House’s power weakened, so it had to resort to evil and turn the situation around.
“Looking at the current atmosphere at the Blue House, it looks like clinical trials will proceed quickly. And as was the case during the first clinical trial, there are quite a few infected patients who want to participate in the clinical trial.”
“The arrows of anger may shift to the Ministry of Food and Drug Safety, so we will mobilize all of our manpower to expedite the release of the MERS treatment.”
“A cure may be available within a month or two.”
The launch of a treatment was a foregone conclusion.
However, it was unlikely that the government’s approval rating would rebound even if a treatment was released.
There has already been a lot of hate, and a significant number of lawmakers from the ruling party have turned their backs on the president.
* * *
Exactly 41 days.
Now, 41 days after the emergency use approval system was announced, a MERS treatment has been officially released.
I visited Centrian to check the situation for myself.
MERS treatment was being produced under the leadership of Dr. Kim Jang-woo.
“Thank you for your hard work. Do you need to manage the production process yourself?”
“I know very well that performance will not improve even if I step out, but my feet keep heading towards the production plant. Hehehe.”
It was Dr. Kim Jang-woo, who looked bright.
The results of the second and third clinical trials conducted jointly with the Ministry of Food and Drug Safety were also very good, so he no longer had to worry.
“How much MERS treatment are you producing?”
“The quantity is not that large. The number of infected people in the country does not exceed 200, so there is no need to mass produce.”
“Wouldn’t it be a waste to only sell the treatment we made domestically? So, we are going to proceed with the US FDA approval process.”
“Will the strict US FDA easily grant approval?”
Everyone in the pharmaceutical industry knew about the strictness of the US FDA.
In particular, when it comes to new drugs, approval could only be obtained after going through a process so complicated that it was difficult to compare with Korea.
“Approval will not be difficult. The results can be confirmed directly at a large-scale clinical trial site in Korea.”
“That’s true. There is no place other than Korea where MERS is being treated on such a large scale.”
In addition to Korea, people infected with MERS were appearing in many countries.
However, there are few cases where the treatment process is disclosed as transparently as in Korea and various data are fully preserved.
“And Taewoo Group has had a very good relationship with the FDA for a long time. It looks like it will be able to get approval within this year at the latest.”
“Is that so? That’s really good news.”
“It is also welcome in the United States because a Korean pharmaceutical company has created a MERS treatment that even American pharmaceutical companies do not make because it is not profitable.”
This was the case in the case of SARS treatment.
An American pharmaceutical company first began development, but eventually gave up due to economic feasibility issues.
MERS was no different from SARS, and its economic feasibility was not high.
However, this does not mean that there are no MERS patients in the United States.
Therefore, it was necessary to secure a certain amount of treatment at the government level.
Since we had solved that problem, the U.S. government would welcome us with open arms.
“There are more than 100 samples of Korean infected patients, so the U.S. FDA will be able to give approval without difficulty.”
“We plan to take this opportunity to go through the FDA approval process for a diabetes treatment along with a MERS treatment.”
Diabetes drugs were already undergoing the FDA approval process.
However, the FDA’s schedule was so tight that no progress was being made.
Therefore, if we went through the same procedure as 1+1 with the MERS treatment, we could get approval more quickly.
“The effectiveness of treating diabetes is excellent, so we expect to receive FDA approval without any major problems. The clinical trial results are also very good. There are very few side effects, but they do not have a negative impact on health.”
“Are you talking about the weight loss side effect? If anything, the new drug will be in the spotlight more because of that side effect. So I have one more thing to ask you.”
Dr. Kim Jang-woo was a person with strong pride.
I was trying to ask that person a favor that could be hurtful.
“I hope to create a new drug by adding more ingredients that cause weight loss side effects. I hope to use it as a diet treatment for weight loss rather than for treating diabetes.”
“You’re asking me to create a new drug to treat obesity.”
“I apologize if this is a rude request.”
“No. We have long been concerned about various diseases caused by obesity. Personally, I believe that obesity is also a part of the disease.”
It was a different reaction than expected.
I was trying to create a treatment for obesity for cosmetic purposes.
However, Dr. Kim Jang-woo thought that obesity treatment was a disease treatment.
“Then, please, please move up the schedule so that obesity drugs can also go through the FDA approval process as soon as diabetes drugs are approved by the FDA.”
“It’s not very difficult. It’s just a matter of slightly adjusting the ingredients of a new drug that’s already been made, so it can be completed in a short period of time.”
I felt sorry for Dr. Kim Jang-woo.
Because I gave him a new homework as his voice cracked and his body sagged.
Of course, we were providing the highest level of salary and benefits in the industry, but we were planning to pay him the largest bonus ever once this job was over.
* * *
A few days later.
David came to Korea.
After a long time, we held a small welcome party with Vice President Han at Captain Kang’s office.
“Do you know how much I miss this place? I miss it more than my hometown.”
“Staying in a luxurious, palace-like office, what do you miss so much about here?”
“Just because the office is big doesn’t mean it’s good. It just makes me feel more lonely.”
I enjoyed beer with ramen as a snack.
Only after emptying a can of beer did David reveal his purpose for coming to Korea.
“I came to Korea with the FDA people. There is also great interest in the MERS treatment in the U.S. Thanks to this, I was able to bring the FDA staff to Korea without much lobbying.”
“Have there been any discussions with the Korean Ministry of Food and Drug Safety?”
“I heard that the FDA and the Ministry of Food and Drug Safety have decided to secretly share clinical trial results. In the case of MERS treatment, there does not seem to be a need for a separate FDA approval process. It seems they are planning to give approval after looking at the treatment status of infected patients in Korea.”
It was never a bad situation for us.
It was very rare for the FDA to come forward proactively.
“How is the approval of diabetes treatments going?”
“Now that the FDA staff are here, we can push hard. Wouldn’t trust increase since it is a diabetes treatment made by the company that developed the MERS treatment? Moreover, it also produces insulin.”
What if a new company developed a diabetes treatment?
The FDA would have reviewed it more strictly, and even if it met the conditions, it could have delayed approval until it was sure.
But Centrion has been taking steps step by step.
A new flu treatment, insulin production, MERS treatment, and even diabetes treatment.
“Then try to get your diabetes treatment approved by the FDA within this year.”
“The FDA is already planning to visit Centrian in person to check the MERS treatment. At that time, you can also show us the diabetes treatment. If you can see the clinical trial results and related data with your own eyes, approval will be faster. Won’t you lose?”
New drugs are ultimately divided into success and failure depending on the results of FDA approval.
If a diabetes treatment could be approved by the FDA, Centrian would have wings on both shoulders.
Huge wings that will soar not only sales but also stock prices.