#Preliminary #Approval of #Genervon #GM6 For Use In #ALS #MND #neurodegenerative #diseases #AD #PD Change.org Nicholas Grillo San Francisco, CA In February 2015, Genervon will be meeting with FDA for accelerated approval of GM6 for all ALS patients. GM6 is very safe with no significant adverse events in any treatment group. Additionally, GM6 is efficacious including Genervon trial programs for other neurodegenerative diseases. GM6 should be advanced to conditional approval in a post-marketing surveillance program based on the following: 1. Demonstrated safety 2. Certain death for thousands of ALS patients during the time necessary for a Phase 3 3. Statistically-significant efficacy between treated and placebo groups in biomarker data 4. Statistically significant efficacy between treated and historical control groups in clinical data (Please see Genervon Announces ALS and PD Phase 2a Trial Results and Genervon Announces ALS Compassionate Use Results) businesswire/news/home/20141019005074/en/Genervon-Announces-ALS-PD-Phase-2a-Trial#.VLQqOSeBBBI businesswire/news/home/20150108005470/en/Genervon-Announces-ALS-Compassionate-Results#.VLQ1hieBBBI As the FDA undoubtedly appreciates, an entire generation of newly diagnosed ALS patients likely would die in the time it would take Genervon to conduct another round of clinical trials before GM604 could be approved and made available to treat ALS patients. While acknowledging the paramount importance of public safety in the FDA’s drug approval process, the American people (as well as people around the globe) also believe that ALS presents a compelling case for an exception to the usual process. A NOTE FROM NICK: As a person with ALS, I need treatment options RIGHT NOW. The risk of GM6 at this point is extremely acceptable to me and many others with ALS, especially given that without treatment the risk is 100% fatal. We cannot wait another few more years while tens of thousands of us die. I ask the FDA to allow GM6 preliminary approval and market surveillance for final determination. Doing so would very likely mean rescue from ALS for many tens of thousands and certain hope for all. https://change.org/p/food-and-drug-administration-preliminary-approval-of-genervon-gm6-for-use-in-als
Posted on: Mon, 12 Jan 2015 21:26:36 +0000
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