RE:RE:RE:RE:RE:RE:Expanded Access
China has a billion ppl, bur all TLT has is a patent in China, no approvals to test, enroll, etc. China has a similar process as the FDA, it used to be called the CFDA, but I believe there is a new name. Trying to start a trial in China will take years and resources away from the current goal. Once any Country sees a successful Phase II trial, think will be much easier. Below is a excerpt from the Chinese approval process, it is not as simple as some posters believe:
"Only 100 new drugs were approved between 2001 and 2016, about a third of the number in most Western countries. Approval times have been cut from six to seven years down to two or three years and data from overseas clinical trials is now accepted"
G1