They sue me because the medicine is illegal, but if it is legal, they say I can't afford it?
Chapter 270 Preparing for Phase 2.
……
A few days later,
Chen Xuan came to Antai Pharmaceutical Base again.
He did not go directly to the laboratory, but first found Luo Shiyun and Yang Qingfeng.
"The first phase of clinical trials has come to an end."
"From all the reports so far, the results have basically exceeded expectations."
"Both the therapeutic effect and the adverse reactions are far higher than initially expected. Even patients with advanced lung cancer have seen significant improvement."
After inviting the two to sit down in his office, Chen Xuan directly told them the result.
The results of the clinical trials of the effective drug for lung cancer have indeed brought great surprises.
Not only did no unexpected situations occur, but the actual performance was much better than expected.
Judging from the current results, the lung cancer specific drug is already a very successful specific drug with almost no adverse reactions.
The side effects are minimal.
For patients, as long as they can cure their diseases, these side effects can be completely ignored.
Although the results of this clinical trial are very ideal,
Luo Shiyun and Yang Qingfeng also showed joy on their faces.
Happy with the result.
This means that the launch of the effective drug for lung cancer is almost a certainty, without any suspense.
"Results from Phase I clinical trials."
"We've figured out the best dose, delivery method and route of administration."
"So, now we can start applying for phase II or even phase III clinical trials."
Chen Xuan then immediately stated his decision.
The reason why I asked Luo Shiyun and Yang Qingfeng to come here this time was also for this matter.
And he didn't discuss with them, but informed them.
Based on the results of the Phase I clinical trial, there will basically be no problem in applying for the Phase II clinical trial.
Given the importance the country attaches to special drugs for lung cancer, it will definitely give it the green light.
Of course, there is absolutely no problem with the performance of lung cancer specific drugs, which is also the main reason for accelerating the progress of clinical trials.
It is not that lung cancer-specific drugs have privileges. Any other innovative drugs that can perform in this way can also receive this special treatment.
It’s just that other innovative drugs have too many uncertainties during clinical trials, which makes the entire process very long, and it mainly depends on continuous trial and error.
The three points of optimal dosage, administration period and administration method alone need to be verified multiple times.
But a specific drug for lung cancer is not a problem.
Chen Xuan provided very comprehensive guidance, so that targeted experiments could be carried out.
In other words, everything about other innovative drugs is unknown, and only through continuous experimentation can we know which method is the best.
But he can know which method is the best and most suitable from the beginning, so there is naturally no need to repeat the experiment.
In this way, the trial time of lung cancer specific drugs can naturally be more efficient than other innovative drugs.
Therefore, Chen Xuan believed that if he applied for the Phase II clinical trial now, the drug administration would basically have no objection, let alone any obstruction.
As long as the specific medicine for lung cancer is confirmed to be effective, there will be no problem.
So both the country and patients hope that this drug can be available on the market as soon as possible.
After the second phase of clinical trials are launched, the third phase of clinical trials can basically be carried out at the same time.
By then, the specific drug for lung cancer will be close to being approved for marketing.
"Based on the data we have now."
"I think the Food and Drug Administration should agree to let us conduct the second phase of clinical trials."
"Moreover, lung cancer-specific drugs are indeed very mature drugs, and we have all the conditions."
Yang Qingfeng immediately expressed his support for Chen Xuan's decision.
"I agree too." Luo Shiyun followed suit.
She also knew that the specific drug for lung cancer was very mature and its trial results far exceeded expectations.
Even if Chen Xuan didn't make this decision, she would still make this suggestion.
Not to mention him, even if the country knew the results of the first phase of clinical trials, it would probably encourage him to directly start the second phase of clinical trials.
So it is indeed very appropriate to conduct the second phase clinical trial now.
"Phase II clinical trial."
“How big of a scale are you prepared to participate?”
"A typical Phase II clinical trial involves around a hundred participants."
Luo Shiyun asked again.
How many participants are needed for Phase II clinical trials?
For other innovative drugs, a Phase II clinical trial with hundreds of participants is considered very good.
But the specific drug for lung cancer is different. In the first phase of clinical trials alone, more than 300 people have participated.
It's impossible that the number of participants has decreased in the second phase of clinical trials.
"I plan to tentatively enroll 1000 people in the Phase II clinical trial."
"As for the list of volunteers, try to screen as many people as possible from the group outside."
"It's not easy for them to wait outside for so many days. If they meet the requirements, they will be given priority."
Chen Xuan made the decision directly.
The people outside he was referring to were those waiting at the Antai Pharmaceutical Base.
Since the clinical trials of the lung cancer drug began, many liver cancer patients have been waiting outside the pharmaceutical base, hoping that they can be selected.
Even though the Phase I clinical trial has already begun, they still haven't given up, hoping to get a chance to be a substitute midway or become a volunteer for the Phase II clinical trial.
For these people, the specific drug for lung cancer is their only hope, the hope that they or their families can survive.
……
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