Conversions are supposed to end soon. They have financing for American trials but the financing won’t happen unless the company shuts down conversions.
They got shut down last time on FDA due to the “sensitivity” of the unit not being at 99%. He said that was unrealistic. They have been going back and forth with FDA about this.. it is now down to 96% for acceptance. The results submitted last time were between 98-100% sensitivity. They think that it dropping down will allow acceptance this time. He didn’t give me any info that wasn’t public, so don’t think this is privileged info.
China is good. Will update soon. 3 guys will be here in February from China. Don’t know what that means exactly but he seemed extremely optimistic about it.
China has paid about 800k of the million they were supposed to. I believe he said they have 150k or so more to pay. Looking good here.
China had to manufacture the system completely before they would be eligible to submit for CFDA approval. He said it’s a lot of red tape.
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