Neuigkeit zur PetitionFDA Accelerated Approval of Genervon's GM604 for Use In ALSThe lives of 500,000 people rest in the hands of the FDA
Nicholas GrilloSan Francisco, CA, Vereinigte Staaten
16.02.2015
Congratulations! Our petitions have reached over 207,000 signatures but a lot more work needs to be done! We are changing our goal to 1 million signatures and together with your support we are confident that we can reach this goal. In a press release this morning Genervon discussed their work with developing drugs for nervous system disorders and diseases, our campaign, misinformation about the GM604 Phase 2a trial, and their meeting with the FDA (link to press release below). As most of us expected, the FDA made no final decision about Accelerated Approval with post-marketing requirements for GM604. In today's press release, Genervon states: “We were grateful that many senior-level FDA officials attended the meeting and that they expressed support for GM604 and its prospects. We were disappointed, however, that other FDA personnel seemed inclined to require Genervon to follow a conventional drug approval process. We left the meeting not knowing what the future holds for our request for accelerated approval for GM604.” It is extremely important that we remain vigilant in reaching out to the FDA and key U.S. Senators on the H.E.L.P. Committee during this time of waiting. Please email or tweet the FDA today (email addresses below). We’ll target key senators later in the week. If you have already sent emails to the FDA in the past, do it again with the new knowledge that this meeting has now taken place and no decision has been made. 1) Share your personal story and thoughts with the decision makers at the FDA. 2) Tell the FDA you are aware that Genervon has met with them and no final decision on GM604 has been made. 3) Tell them you support the grassroots campaign urging the FDA to promote GM604 to their Accelerated Approval Program. 4) Kindly remind the FDA that more trials means more deaths as people with ALS do not have time to wait. Link to Genervon press release: http://www.genervon.com/genervon/about_pressreleases.php Thank you Nick Grillo, Jehad Mejad, and Bethany Cleveland To email the FDA, address the email to: druginfo@fda.hhs.gov Then cc these people at the FDA: margaret.hamburg@fda.hhs.gov william.dunn@fda.hhs.gov stephen.ostroff@fda.hhs.gov And cc these news shows: news@cbsnewyork.com Viewermail@newshour.org contact.nbcnews@nbcuni.com anderson.cooper@turner.com foxnewstips@foxnews.com To tweet FDA: http://ctt.ec/uEdGb Check out our campaign website and Facebook page: https://sites.google.com/site/aap4gm6/ https://www.facebook.com/gm604forals
Link kopieren
WhatsApp
Facebook
E-Mail
X