I don't think there's a risk on failure to approve, if there was any question they would have required an advisory panel. So, there's somethng else causing the delay. I don't want to raise expectations, but is it possible FDA is considering approval for a wider range of patients? If so, that would likely have leaked and the stock price would be up. I just hope we don't get some stupid last minute FDelay, BC patients and IMGN shareholders have waited too long already.
My guess is the FDA has already contacted the company (Roche/Genentech) and they are discussing exactly what the label will read. The data for TDM1 is compelling in all trials it has been in to date and the FDA is well aware of this.
It's not a delay yet, but given the results and the filing 2 years ago, FDA should be familiar enough to approve this faster than the last possible day. Very disappointing unless they are planning to deliver a positive surprise. Given the inability to keep any information in the biotech industry confidential, I assume anything positive or negative would have leaked by now.