It was because he realized that the other party might have really encountered a lot of difficulties that
Liam Weaver was not angry at all because of the other party’s lateness.
Instead, he nodded very understandably and politely said, “It’s okay, Mr. Smith.
I have nothing else to do.
Don’t worry.”
“Thank you!” James Smith thanked him and smiled politely before sitting in front of Liam Weaver.
The two ordered some meals at will, and James Smith asked Liam Weaver, “Is there anything
important for Mr. Weaver to come from China so far away?”
Liam Weaver laughed and said, “Mr. Smith, you should have heard of Oracle Pharmaceutical?”
“I’ve heard of it.” Smith nodded and said, “Do you have a drug under review by our FDA?”
“Yes.” Liam Weaver said quickly, “It has been a long time since the review cycle, and it has not entered
the next stage, so I want to ask if there is any way to speed up.”
Smith said in a dilemma, “Now the FDA’s review of imported drugs is very strict.
This process is indeed very long, and I can’t clearly tell you whether it meets our standards and can be
approved for listing after going through all the processes.”
Liam Weaver explained, “Mr. Smith, the ingredients of our proprietary Chinese medicine are very safe,
without any toxic and side effects, and the effect is very good.
It can be said that it is immediate.
Will this medicine also be rejected by the FDA?”
Smith nodded and said, “In recent years, we have been receiving applications for drugs from Eastern
countries, and the vast majority of them are proprietary Chinese medicine you mentioned.
Not only China, but also Japan and South Korea have submitted a lot, but the vast majority have been
rejected.”
Liam Weaver asked puzzledly, “Why is this?”
Smith said very seriously, “Mr. Weaver, our Western requirements for drug testing and auditing are very
different from traditional oriental medicine.
One of the most important points is that there must be clear pharmacokinetic tests.
You must clearly tell us what the effective ingredient of this drug is, for what reason, and what role it
plays.
You must also tell us whether this drug has toxic side effects in the body, especially the liver and
kidneys, and how long the metabolic cycle of its ingredients in the body.
If I don’t know this, we can’t allow it to enter our market for sale.”
Liam Weaver said quickly, “Many Chinese prescriptions have very complex prescriptions, so their
internal ingredients are also very complex.
Unlike Western medicine, most of them are chemicals, there is often only one active ingredient, such
as penicillin and aspirin.
One molecular formula can reflect its actual composition, and all proprietary Chinese medicines are
difficult to reach.
This kind of request from the West, but shouldn’t it be like this to seek common ground while reserving
differences?”
Smith shook his head and said, “I’m sorry, Mr. Weaver, we can’t seek common ground while reserving
differences.
The rule is that all drugs that want to enter the U.S.
market must in principle comply with all our rules, otherwise they cannot be sold on the market.”
Liam Weaver said quickly, “Our medicine works very well, which is recognized by all patients and are
best-selling drugs in many countries.
As far as I know, many American patients buy our Nova Dias through purchasing agents, but this
method is not only long, but also much more expensive.
They also hope that the FDA can approve the medicine to enter the U.S.
market.”
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