Both safety data and stat analysis in RTF are very unusual. By the end of Sept for target resubmission, it seems they think it takes quite a long time to put these together.
It took them 9 months or so to submit an NDA that was RTF'd for all reasons except that the return address was valid. Another half year to patch it. Sounds like a stall to me.
A year ago the management was sounding like they belong on a Saturday AM radio infomercial.
Trying to hype cooked OS numbers was the glaring issue here, but I thought the claim of billions in sales in China was the best laugher. The Delcath product is some off patent plumbing, anybody who thinks it has a future in Asia deserves their haircut.