Tuesday, August 08, 2023 8:46:29 AM
Thermo, the take home, for me, from your post is less about the timing of when they will submit and more about that they really really are in the process of getting to submit relatively ‘soon’.
It has taken them a seemingly long length of time from when we first started expecting topline data back in 2013 -2014 (that seems so funny now) to get to this point that waiting a little longer is almost irrelevant to our expectations for DCVax-L. I say a 'seemingly' long length of time because, in hindsight, this novel immunotherapy trial was leading in a paradigm shifting way via: the shift from PFS to OS endpoints, 5 year data vs 2 yr, old definitions of GBM (IDH1 analysis, etc), the unethicalness of randomized trials for diseases where the use of current therapy is a death sentence, the use of External Control Data, manufacturing, and heck, even the Good Documentation Practices standards changing from 10-15 yrs ago possible causing issues before they locked the data.
So knowing from your deeper insights in your discussions w management that they are very close to submitting the application i.e. that it really IS going to be submitted, is reassuring. Thx.
It has taken them a seemingly long length of time from when we first started expecting topline data back in 2013 -2014 (that seems so funny now) to get to this point that waiting a little longer is almost irrelevant to our expectations for DCVax-L. I say a 'seemingly' long length of time because, in hindsight, this novel immunotherapy trial was leading in a paradigm shifting way via: the shift from PFS to OS endpoints, 5 year data vs 2 yr, old definitions of GBM (IDH1 analysis, etc), the unethicalness of randomized trials for diseases where the use of current therapy is a death sentence, the use of External Control Data, manufacturing, and heck, even the Good Documentation Practices standards changing from 10-15 yrs ago possible causing issues before they locked the data.
So knowing from your deeper insights in your discussions w management that they are very close to submitting the application i.e. that it really IS going to be submitted, is reassuring. Thx.
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