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Re: biosectinvestor post# 508602

Sunday, 08/28/2022 2:12:03 PM

Sunday, August 28, 2022 2:12:03 PM

Post# of 824060
"presumably DCVax-L will be approved"?? That won't be until into 2024. Going to take NWBO months to put together the assorted regulatory applications. FDA will take a year for application acceptance and review. That's assuming they a.) accept the application and b.) they don't deliver a CRL.

As NWBO has shown pretty poor regulator interactions (trial hold), decade plus to run a trial, complete redo of the trial protocol, etc. Ain't going to be very soon.

NWBO is the comparator arm, not a placebo. Keytruda is the treatment arm that is being assessed, not DCVax-L. Dr. Liau has moved on and is not touting combination therapy and certainly not claiming DCVax-L is sufficient by itself. Filing a mono-treatment with the dubious trial data -- totally redone protocol/SAP and confounded OS data is going to make the review (if accepted), pretty questionable.
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