@adamfeuerstein@Keubiko Wrong again “doctor”. Neither I nor my colleagues would have signed on to the final paper had the data been manipulated as you so egregiously accuse. FDA required the crossover. Therefore nearly all got the DCVax at some point requiring the contemporaneous control group.
@adamfeuerstein@Keubiko I see it time for another episode of “Whack-A-Troll”. I wonder “Dr.” Feuerstein from where your detailed clinical knowledge of this trial emanates? Did you, like me, care for any of these patients? Chart the MRI responses or see them back for years at clinic appointments?
@apwriter @UCLA Annie - love most of your post but you are a little heavy handed on TTFs. They work somewhat. Tough for patients to comply with skin electrodes but the technology works. Too expensive per QALY for NICE to approve for UK. I have long term survivors from TTF (10+ years).
@adamfeuerstein I share some of the concerns with authors of this critique. But there is signal in the DCVax data and a number of long term survivors (similar to the EF-14 TTF trial). More studies of this vaccine with ICB is the solution. Not abandonment of this technique.
@exRepublican18 @apwriter @Nina_kd@burket_tom@D1ssoluti0ng0v@OTCMarkets@IamBreastCancer Indeed. I can. And can you run large clinical trials? And can you parse terabytes of RNA sequencing data? And can you perform awake craniotomies for resection of glioblastoma? When you can I will respect your opinion. Until then - bye bye
@exRepublican18 @apwriter @Nina_kd@burket_tom@D1ssoluti0ng0v@OTCMarkets@IamBreastCancer I was paid for being Chair of the department and doing surgery. What are you paid for? Would love to see your disclosures. Must be some reason to spend your Saturday trying to sink a viable and important cancer therapy. Hmmm … what could be your motivation? I wonder
@exRepublican18@Nina_kd@burket_tom @apwriter @D1ssoluti0ng0v@OTCMarkets@IamBreastCancer And I guess the new epigenetic and micro environmental drugs my team is working on should just be thrown away because we have no idea what we are doing. Thankfully neither my patients nor the FDA will be relying upon your ill informed Twitter excrement. Have a wonderful day!
@exRepublican18@Nina_kd@burket_tom @apwriter @D1ssoluti0ng0v@OTCMarkets@IamBreastCancer I guess I am part of the “fraud” since I am an investigator and I continue to advocate for this platform. Guess I have wasted the last 35 years in Neurosurgery practice and glioblastoma research. Thanks for pointing out my obvious shortcomings Ex-Republican
@adamfeuerstein And I have also admitted the data is not simple to interpret. But there is improved survival in many of my and the rest of the study patients. Further study with ICB already underway at UCLA with impressive results. Needs to be approved and studies continued.
@adamfeuerstein I thought someone who writes for a living would understand the original Latin meaning of post hoc. I was not referring to the meaning in statistics meaning after the data were seen which (not the case here). Claiming it was a post hoc stastitical analysis is a lie. So stop lying
@adamfeuerstein Every cancer survival analysis is “post hoc” since you cannot analyze survival / death event until after the event. You seem to suggest that the endpoints were changed after the data had been unblinded. Simply not true. Fortunately the FDA does not rely upon StatNews to approve.
@adamfeuerstein 1) DCVax trial was positive not failed with Increased OS. 2) The steps for producing a DCVax are a bit more complex than “waving around tumor lysate”. 3) Woukd be happy to share some single cell / methyl RNA Seq data to show you why the Moderna approach won’t work as well in GBM
@adamfeuerstein So today Dr Feuerstein wants to compare a Ph 2 trial of the most immunogenic cancer to a Ph 3 of the least immunogeneic. Agree that mRNA vaccines may be useful but sequencing and mutations only account for a small percentage of potential mutations and neoangiogenesis epitopes.
@MidwestHedgie @XBIObserver Hard to believe you have nothing better to do than to enrich yourself by shorting a stock / company that could open the doors of immuno oncology for those with previously untreatable tumors. So smug for a physician who has never treated nor is qualified to treat GBM patients
@MidwestHedgie And I see your short interest in $NWBO overrides the interest of the patients in getting a useful therapy. I would prefer to continue to evaluate this therapy in further trials and combos than to have a Type II error and throw out 20 years of work and say this doesn’t work.
@MidwestHedgie If you are asking for ITT OS analysis essentially the ndGBM curves are that (but not vs. internal control because of crossover). Been a part of many failed trials in GBM last 35 years. Losing patients too fast not to have this to continue to evaluate / improve.
@MidwestHedgie By 2015 enrollment of the trial had been completed. Therefore no new patients. The change from PFS to OS was needed because the inflammation caused by immune therapies mimicked progression. Hence PFS not a reliable outcome. Much simpler than you imply. There is no conspiracy.