RE:RE:RE:RE:RE:RE:RE:pre-BTD and BTD
Great points all around Eog. I'm just guessing based on what I have seen in my area of work.
I thought that the 6m treatment was a tweak but I couldn't find my reference so I must have misremembered. Thanks for catching that.
Overall, all I've been saying is that in areas that I'm familiar with, outcomes that are considered as most informative are ones where you have 12m follow up from the last treatment intervention. When I saw that they announced that they were working on getting BTD application ready but not there yet, it struck me that one of the few data points that they might need to chase down (vs have on file already) is 18 month follow up.
Recall that when Immunity bio got a CRL not that long ago, the main issue was manufacturing. However, one other issue that was mentioned was
FDA did request that the company provide updated “duration of response data of the efficacy population”
Source https://www.biospace.com/article/fda-rejects-immunitybio-s-bladder-cancer-therapy-sends-stock-tumbling/
Immunity bio had data on CR and follow up to 27 m ( see https://evidence.nejm.org/doi/full/10.1056/EVIDoa2200167) so the FDA seemed to have still said that they wanted more info on duration even though that data was out to 27m.
Nothing I'm saying changes anything that we are doing (holding and waiting). Just making conversation :)