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Saturday, 08/09/2025 10:28:39 AM

Saturday, August 09, 2025 10:28:39 AM

Post# of 590
Exwannabe: On October 29, 2018. (About 36 months after last patient randomized in the DCVax-l phase iii trial.)

“BTW, as of about next week (plus or minus a couple weeks) there are no longer any patients being treated, examined or scanned; only followed by phone calls to see if they are still alive”




https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144524178&txt2find=Last%20patient%20randomized

I was trying to remember where I learned the last patient was probably randomized approximately the first week of November 2015. It was on Ivillage where Exwannabe or one of his cohorts found a post on a patient forum, and the above old ihub post jogged my memory.

I now think the last patient randomization was November fourth or fifth, 2015, I can’t remember, but it fits NWBO’s broader month of November statement the last patient enrolled/randomized, and the two words can be used synonymously for end date purposes in this trial on that stat.

In other words, we are about three months shy of ten years.

Whereas, if MHRA and NWBO are not “late” under the new maa rules, MHRA’s deadline for maa decision is October 2, 2015 (give or take nine days, because MHRA doesn’t turn the clock back on until 3 days after NWBO responds to each RFI) if there were three RFIs and clock started on March 6, 2024 plus 210 days clock on and 365 days clock off under the new April 3, 2025 MHRA guidance rules.

The ten year data would certainly be important for any submission to NICE and/or FDA , imo.

(Note: The Survaxm primary endpoint control arm result (along with treatment arm) could potentially be public by August 18, 2025 (required reporting date) imo. Give or take four days. This might also be important for NICE and the FDA) (Interestingly, Survaxm 2b trial also used enrollment and randomization completion date synonymously as well)

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