This timeline has been rehashed many times. We "could" hear/see something as soon as Monday or not until Wednesday/Thursday The 4 day timeline to file an 8K comes into play. As Rocky on I-Hub explains. Bio does a nice job explaining his thoughts on this as well.
I just needed a confirmation that the timeline indicated in Chapter five of my link was correct or this other first version I read in an AIDs drug IND filing. It seemed strange to me, that clinical trials could start if the FDA had not responded in one month.
In other FDA related issues, letters for a delay of response within a mandatory timeline are quite common due to work overload.