@DCVaxDefender@AlMusella@ThomasOwenMcCa1 The "tail" of the curve—the percentage of patients who achieve long-term, durable survival—is where the actual transformational value lies. The 4 mOS adding optune doesn't justify the cost.
@DCVaxDefender@AlMusella@ThomasOwenMcCa1 When you evaluate a therapy for an aggressive disease like glioblastoma (GBM), relying solely on the median overall survival (mOS) is a flawed metric for determining its true commercial and clinical potential.
@KennethPar49290@DCVaxDefender@AlMusella@ThomasOwenMcCa1 Payers will not expand coverage or modify their criteria to allow for upfront, concurrent billing during the initial radiation/temozolomide phase.From a budget-impact perspective, this "miss" saves payers from facing an immediate push to fund an additional 6 to 8 weeks of dme
@KennethPar49290@DCVaxDefender@AlMusella@ThomasOwenMcCa1 Current medical policies for Optune restrict authorization to the maintenance phase (post-chemoradiation, after initial debulking and radiation are complete, typically requiring a Karnofsky Performance Status (KPS) >79%.
@MDendream@Doc_Hieu For patients who are resilient enough to complete full treatment stupp, major cancer centers (like MD A. etc.) generally quote a median life expectancy of 15 to 18 months. The landmark 2005 clinical trial that established this standard reported a median survival of 14.6 months.
@mabbpah@BioPharmaMrkt@rjmsoflo Tylenol is a mass-market beer, millions of identical cans made in an automated factory. DCVaxL & stem cell therapies are bespoke, single-barrel whiskeys made from the customer's own ingredients. And the MHRA requires manufacturing licenses to produce both of them. Not just $NWBO
@mabbpah@BioPharmaMrkt@rjmsoflo Literally everything in this post is factually wrong. 1. Tylenol is a mass-produced, simple small molecule (C8H9NO2). 2. Stem cell gene editing alters living human DNA, they aren't even in the same scientific universe.
@sentimentstock it means, we lined up the data apples-to-apples, & the vaccine still definitively won.The survival extension (19.3 vs. 16.5) wasn't an illusion caused by trial enrolling "healthier" people.math holds up even when forced through the strictest comparative filtering available.
@TonyVerazzanno@PK_Fund If you ever taken a allergy shot you will have pain at the injection site. Maybe some redness and swelling. I will agree 900 days is some time. I too am tired of waiting. But gonews is there has been no rejection.
@TonyVerazzanno@PK_Fund The MHRA isn't debating if the Phase III survival curves worked; they are validating the bridging data to ensure the new commercial machines can flawlessly reproduce the exact same product before they allow thousands of patients to be treated."
@TonyVerazzanno@PK_Fund Second, claiming there are 'NO SECONDARY EFFECTS' is medically inaccurate and makes the data sound unscientific. DCVax-L has a highly favorable safety profile compared to the toxic chemo standard-of-care, but it still has documented, standard vaccine side effects.
@neilmck37597308 In short, the application was built by a decentralized team: Advent BioServices handled the physical U.K. licensing, unnamed specialized consultants wrote the technical modules, and an independent eCTD publisher packaged and submitted the final electronic dossier to the MHRA.
@neilmck37597308 $NWBO Really dumb idea. NWBO used a combination of three distinct groups to get the application across the finish line. Advent BioServices (The U.K. Anchor),The Unnamed "Independent Publisher", Specialized External Consultants & CROs. It was never one person or one group!
@FoxNews once again not understand thats not her job. her job it to take care of those in her state. I'm pretty sure the majority in SC don't care about files and sexual harassment settlements that already occured years before she showed up. Out of touch politician.