Well , then that will imply that this is the final SAP, because if this is intial submission to 4 RAs , there is no way they can get response from all of them and make changes and resubmit and get approval from all four RAs and then unblind in or before sept. Did you ask him if they have been getting inputs from all RAs all these months to modify the SAP?
1. Is there a soft database lock in place? Answer: NWBO never made an official announcement that this lock as yet exists but does not exclude that it will happen in the future.
Well, that should certainly clear this issue up.
We now know it might have happened in the past. Might happen in the future.
I guess the only unknown unknown left unknown is if it might have happened while he was on the call.
Wow! On the soft lock he had a totally different message to me in that they would not be doing all this (supposedly) final data collection scrubbing and query resolution without the soft lock in place as supposedly all the data has to be at the same cutoff date and can’t complete one and then go on to the next as would not have same date without a soft lock date already set. DI never said January 2019 he would not give a specific month so I said let’s just call it January so we can have to soft lock discussion to understand they have to choose a date from which to start the data collection and all data must be cut off as of that date. He did seem clear it was in the past be it nov2018 to January or February 2019
Now in your discussion with him it may be in the future?? Or may be in the past or may be who knows. If the process is as he described, then if the soft lock is in the future it could be a very long time before results
Interesting you talked a very long time and only got one direct answer that has been my experience as well.
They could stand some lessons in transparancy and communication