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hoffmann6383

07/08/23 4:14 PM

#607880 RE: HyGro #607877

Yes, the likelihood of approval is high. VERY high! I'd hate to be the one betting against these odds.

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Foogie88

07/08/23 5:23 PM

#607894 RE: HyGro #607877

Man, you sure hate NWBO. Why so much?
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dstock07734

07/08/23 6:41 PM

#607910 RE: HyGro #607877

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.