Wednesday, September 13, 2017 11:30:45 AM
Yeah I was thinking about this last night... The company might be blinded but they know the number of doses given... They would therefore certainly know the number of doses given on a per patient basis.
10 doses (full regiment) = 30 months survival from randomization. You can bank that patient as someone who benefited from DCVax.
9 doses (9/10 regiment) = 24 months survival from randomization. Someone who will help the trial get approved.
They probably also know, patient X got does 9 on X date, he/she is due for does 10 on X date, did they get that dose? With this data the company can most likely piece together the trial results.
They probably are fine on PFS and OS right now and could stop the trial, In one more month all patients in DCVax Arm will have received 9 doses that have not unfortunately passed, in 7 months from now all patients will have received 10 doses.
I don't think they need to wait another 7 months, but I could see wanting to wait a few more months...
From Smiths Article - sounds like we will be getting OS/PFS numbers for the entire study in that paper to date. This must be good news or why publish this information at this time. Clearly wanting to help the company raise money and survive until they can have a mature data set. FDA on board with this I would imagine.
10 doses (full regiment) = 30 months survival from randomization. You can bank that patient as someone who benefited from DCVax.
9 doses (9/10 regiment) = 24 months survival from randomization. Someone who will help the trial get approved.
They probably also know, patient X got does 9 on X date, he/she is due for does 10 on X date, did they get that dose? With this data the company can most likely piece together the trial results.
They probably are fine on PFS and OS right now and could stop the trial, In one more month all patients in DCVax Arm will have received 9 doses that have not unfortunately passed, in 7 months from now all patients will have received 10 doses.
I don't think they need to wait another 7 months, but I could see wanting to wait a few more months...
From Smiths Article - sounds like we will be getting OS/PFS numbers for the entire study in that paper to date. This must be good news or why publish this information at this time. Clearly wanting to help the company raise money and survive until they can have a mature data set. FDA on board with this I would imagine.
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