InvestorsHub Logo
icon url

antihama

01/31/23 10:46 AM

#563596 RE: Tartiaboy #563280

Tartiaboy, seeing your name pop up made me smile! I guess the short answer to your Q is longs believe the DCVax technology is the real McCoy but there were problems w the P3 trial that was run. The trial which started out ~10 yrs ago used PFS as the primary endpoint and OS as a secondary. Problem one w that is the surrogate endpoint for OS, PFS, should never have been used as a primary endpoint for this immunotherapy due to pseudo progression (psPD). When looking at the scans, the tumor seemed to be expanding. But the patients were living longer. It turns out that what looked like progression was DCVax attacking/infiltrating the tumor making it look like progression but after a while the tumors would shrivel up but it had to be documented as progression initially. When the trial started and immunotherapy was relatively new psPD wasn't on the radar, The second problem w the trial is that, in order for patients to sign up for a trial where the current SoC was ~15 months OS (that # hasn’t changed for ~30 yrs), a patient who got SOC plus placebo would be able to crossover and get DCVax-L (murcidencel). This was a requirement by the FDA because all patients including those getting placebo needed to undergo invasive leukaphereses to maintain the blind, and of the 99 placebo patients, almost 2-thirds crossed over confounding the OS endpoint.

From what I just said and of moving initial manufacturing to Sawston (England), is the basis of all arguments long and short. Many nuances to that including AFs lies and others constantly posting incorrect information even after being corrected multiple, multiple times is what generates so many posts. Once you’re familiar w the posters there are many posts you can skip and posters that you can put on Ignore. If interested, the INTRO to this board has a wealth of info. Sorry for the long short answer but one can write a book about all this stuff if one wants.