RE:RE:RE:RE:RE:RE:FDA IND NEWS!!!!!!!!!!!!!!!!!!Macer wrote
China does one thing really well. They build bigs things fast.
This does not mean that they have the expertise to use the big thing that they have built.
I have worked extensively in China and have been involved with 5-10 hospitals providing training and clinical expertise. I never understood why we called a stupid game that teenagers and college students play "the Chiinese fire drill" (hopping out of your car at a stop light and running around the car many times until light goes green, often jumping back into a different seat) until I went to China.
Much of what they do looks very busy, but accomplishes very little. This is in no way bashing on China because of the recent nCoV outbreak.
FDA IND is getting close with ongoing coordinated discusions and legwork. Not worried at all as this is par for the course as this is a complex application with device, consumable and compound aspects to clarify.
Macer
Hi Macer I talked with Amelia today she informed me that Shawn has dealt with similar situations like this in the past with the FDA and doesn't consider this to be an obstacle in the meantime they are as you say doing the legwork with hospitals now in training getting them ready for the time of approval. As they say it appears no one is sitting on their hands whatever can be done now is being done .... have a good weekend.