AI
Saturday, July 08, 2023 6:41:39 PM
HyGro,
On what grounds will FDA reject DCVax-L? Has any neurosurgeons who gave their GBM patients the treatment other than DCVax-L seen any of their patients living over ten even twenty years?
By now, you should have a rough idea on how many patients received DCVax-L through special program. At least three hundred, I suspect, which means RA will have hundreds of cases like the following two. Clearly one patient, the one who started the treatment in 2013, received DCVax-L for ten shorts over three years combined with SOC, which was consistent with the regimen in p3 trial. For case 1, the patient only received DCVax-L, which, IMO, follows the protocol similar to the combo trial of DCVax-L + Poly-ICLC. Most likely professor Ashkan had hundred of patients receiving the combo. He has a huge amount of data to give him the confidence that three shots are enough. You are here hoping that FDA would reject DCVax-L. You are insulting FDA intellect.
On what grounds will FDA reject DCVax-L? Has any neurosurgeons who gave their GBM patients the treatment other than DCVax-L seen any of their patients living over ten even twenty years?
By now, you should have a rough idea on how many patients received DCVax-L through special program. At least three hundred, I suspect, which means RA will have hundreds of cases like the following two. Clearly one patient, the one who started the treatment in 2013, received DCVax-L for ten shorts over three years combined with SOC, which was consistent with the regimen in p3 trial. For case 1, the patient only received DCVax-L, which, IMO, follows the protocol similar to the combo trial of DCVax-L + Poly-ICLC. Most likely professor Ashkan had hundred of patients receiving the combo. He has a huge amount of data to give him the confidence that three shots are enough. You are here hoping that FDA would reject DCVax-L. You are insulting FDA intellect.
