InvestorsHub Logo

kfa670

01/17/21 1:02 PM

#348255 RE: alphapuppy #348252

This post made my Sunday :)

exwannabe

01/17/21 1:25 PM

#348262 RE: alphapuppy #348252

I always knew that it was BS when they said it would take the statisticians two weeks to analyze the data. There is absolutely no statistical work of any significance that I am aware of that hasn’t taken at least six weeks to do.


AMRN data was about 2-1/2 weeks from data lock to TLD being PR'd. And that trial was over 8000 patients in something like 2 dozen regulatory jurisdictions. And with substantially more endpoints that what we have seen to date for the DCVax-L P3.

From what I have seen, that timeline is reasonably normal. The stat team will already have performed a dry run prior to lock to insure all is right. So the final run should not be much at all.

Where have you see any trial take 6 weeks for the final stat analysis?

The main time delays from "trial is complete" until TLD are getting any final patient visits if needed and the data collection/scrub. On that, AMRN was fairly long at something like 7 months. That was understandable as that needed to get thousands in for a last visit, and these were not cancer patients coming in every few weeks. NWBO announced the trial was complete and there were starting collection/scrub etc over 2 years ago.




CaptainObvious

01/17/21 1:33 PM

#348266 RE: alphapuppy #348252

If it's billable hours then, yeah, it won't be quick.

JTORENCE

01/17/21 1:44 PM

#348270 RE: alphapuppy #348252

alphapuppy What I get from that conversation is we are looking at June for TLD. imo

ATLnsider

01/17/21 2:10 PM

#348279 RE: alphapuppy #348252

alphapuppy, I recently re-watched the YouTube video where you modeled the overall survival (OS) for the DCVax-L Phase III clinical trial, based on the 2017 blinded & blended interim data.

Thank you again for putting this together. Since this is based on 2017 data, what impact do you think an additional 3 years of data maturity will have on your estimated mOS of 26.1 months for the DCVax-L treatment group:


vator

01/17/21 3:01 PM

#348294 RE: alphapuppy #348252

Martin Makary epidemiologist at Hopkins has been ripping the FDA for taking forever with analysis on the Covid vaccines. During interviews he has stated his team at Hopkins could asses the capability of these vaccines in a day or two. He has stated the programs should already be written and after downloading the data the time negligible.

So, I would guess the company has had the data for months.