Petition updateFDA Accelerated Approval of Genervon's GM604 for Use In ALSRally in D.C. and FDA meeting update
Nicholas GrilloSan Francisco, CA, United States
15 May 2015
Dear Petitioners, The Hope NOW for ALS rally in Washington D.C. was a huge success! Our speakers did an amazing job articulating our message. The PALS and CALS that traveled from across the country to attend the rally are truly amazing people. It was an honor to meet all of you! We had good coverage at the rally. Change.org was there recording the event and they will be sending us video footage of the rally very soon. We will post it on our facebook and twitter pages very soon. Wyatt Andrews, National Correspondent with the CBS Evening News and CBS this morning was there to cover the rally as well. We should see something from them later this week or next week. Hope NOW for ALS FDA Meeting: A very strong and informed delegation from our team met with the FDA on May 12th. We received commitments from the FDA to communicate with Genervon and to work with them on a path moving forward for GM604. It is our clear understanding that Genervon has submitted all of it’s data to the FDA. The FDA has failed (for 3 months) to respond to their request for guidance on requirements for the NDA (New Drug Application) for GM604 under the FDA’s Accelerated Approval Program. We also received a firm commitment from the FDA for a continuing dialogue between Hope Now for ALS with FDA senior leadership and review staff regarding the development path for GM604 and all drugs being developed for ALS. Finally, the FDA committed to work with team members Bob Hebron and Stephen Finger on better trial designs for future trials. Genervon could prepare and submit the voluminous New Drug Application (NDA) without guidance, but the NDA could be rejected if the FDA deems it incomplete and restart the approval clock. It is our hope that both sides work quickly to make this happen. We will be watching the FDA very closely to make sure they follow through on everything we discussed. We also made it very clear to them that we will hold them accountable. Here is a list of attendees from our team: Linda Clark (CALS) Matt Bellina (PALS) Jehad Majed (CALS) Gail Gleason (CALS) Bob Hebron (CALS) Beth Hebron (PALS) Angelina Fanous (PALS) Dr. Stephen Finger (PALS) Steven Walker (Abigail Alliance) Frank Burroughs (Abigail Alliance) Remote: Eric Valor (PALS) Dr. David Huntley (PALS) Thank you for all your support, we are making a difference and we will change the status quo. We will not give up until that happens. We’re in this together, Jehad Majed (jmajed@mac.com), Matthew Bellina, Nick Grillo (gm6nick@gmail.com), Anthony Carbajal, Bethany Wolfe, and the Torrino Family
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