Jehad MajedDearborn Heights, MI, United States
May 9, 2015
Fellow Petitioners,  We’d like to update everyone on the status of drug candidate GM604. In early February 2015 Genervon was granted an "end of phase 2" (EOP2) meeting with the FDA and in that meeting they presented the complete trial data plus the case report for Eric Valor’s (http://friends4eric.blogspot.com) Compassionate Use project. On February 24, 2015 Genervon submitted the complete data package with a cover letter requesting guidance under the Accelerated Approval Program. (this is standard procedure) If the FDA were to agree to review a New Drug Application (NDA) under Accelerated Approval then next step for Genervon would be to submit the NDA under AAP consideration. To date, the FDA has not provided that guidance to Genervon. In fact they haven’t even spoken to Genervon since their meeting in February. Instead, they posted a statement on the FDA’s website asking Genervon to release all of it’s data to the public which was highly inappropriate. The ball is in the FDA’s court and has been since February. Why are they dragging their feet? Where’s the sense of urgency? Please read Eric Valors latest blog post. Eric was the GM604 late stage compassionate use patient. He's the one that convinced Genervon to pursue Accelerated Approval. It was not Genervon's idea. This post will set the record straight and put to rest all the misinformation and speculation that's been surrounding Genervon, GM604 and our campaign. http://friends4eric.blogspot.com/2015/05/hope-now-for-als.html Make sure you follow our social media pages along with our new website for the latest information on the Hope NOW for ALS campaign and GM604. http://hopenowforals.org https://twitter.com/hopenowforals https://www.facebook.com/gm604forals We’re in this together, Anthony Carbajal, Bethany Wolfe, Jehad Majed (jmajed@mac.com), Matthew Bellina, Nick Grillo (gm6nick@gmail.com), and the Torrino Family
Copy link
WhatsApp
Facebook
Nextdoor
Email
X