I had that same communication with mr. Innes this week that the company would let us know when data lock occurs. My question to him included either hard or soft lock.
Hope he is correct and they will tell us
If that is correct, my assumption that right now DL may be a reality is incorrect and it is quite possible that DL and therefore TLD could be significantly (or insignificantly) delayed.
I have a hunch that NWBO may have underestimated the time it would take to complete the IDH mutation work. The decision to identify those patients with the IDH1 mutation and those with the wild type most probably was taken sometimes after February 18, the day the April 18 ASM meeting was announced.
On April 18 LP told us that COVID-19 caused the delay in resolving the queries but that NWBO has decided that the additional time needed to resolve the query problem could be used to identify those patients with the IDH1 mutation and those with the wild type. That would constitute a useful addition to the trial.
While I believe that the IDH mutation work will most likely become a valuable addition to the results, I believe that the delay in solving the query problem was used as an excuse to add the mutation results to this trial. In fact, by February 18 most queries had been resolved.
If on February 18 NWBO was planning to have TLD in hand by April 18, they must have also been planning to have DL in hand by no later than March 10.
I doubt that before March 1, the CRO had any difficulty in accessing any hospital sites. They may have met some obstacles in the coming weeks but with a planned TLD by April 18, almost all of their queries that did not involve the mutation work must have been resolved before March 1.
I therefore believe that the delay in reaching DL and TLD that we have been experiencing were caused by the work involving the IDH mutation and the delay in answering queries was just an excuse.
Let us hope that the information pertaining to the IDH mutation, justifies the additional delay that we are experiencing.