Actualización de la peticiónFDA Accelerated Approval of Genervon's GM604 for Use In ALS100,000 and growing -- lets keep up the momentum!

Nicholas GrilloSan Francisco, CA, Estados Unidos
23 janv. 2015
This is a very exciting moment: we just surpassed 100,000 signatures from people calling on the FDA to stand with the ALS community and approve GM6!
It is incredible to have all of you standing with us. Thank you for your support and being actively involved in this campaign.
Over the weekend Genervon reaffirmed their support for accelerated approval of GM6 to help the entire ALS community, and now it is important that we keep up our momentum to show the FDA we need their support.
MDA/ALS magazine has also acknowledged our petition and GM6, but Grace Pavlath, MDA's scientific program director, does not believe the FDA will approve our request -- which is why we still need your help.
Eric Valor, a GM6 compassionate use patient and a signer on our petition, stated recently:
"We believe we have a strong enough efficacy signal to skip the traditional Phase 3 and move to market with Accelerated Approval with a surveillance program built like a Phase 3. There should be absolutely no doubt that ALS has ‘a serious unmet need’ for treatment. There are no effective treatments for ALS (riluzole need not apply). Genervon is not asking simply for drug approval. The company and the petitioners are asking for a particular FDA program which temporarily allows a drug intended for patients with no other treatment options to be on the market while further efficacy and safety data are gathered. Upon examination of the data the approval can be made permanent or revoked. The cancer drug Avastin was a recent example of this."
This should clarify what we are requesting from the FDA. It's time to think out of the box when developing and testing drugs for serious diseases like ALS.
Paul Aiken, our co-petitioner, explains this in more detail on his blog:
https://nequals2.com/gm6-breakthrough-basics-how-the-fdas-accelerated-approval-program-works/
Now that we have reached this signature milestone, we would like to ask everyone to continue to share the petition with your friends and via social media by clicking here to tweet directly at the FDA to tell them you support approval of GM6: http://ctt.ec/2d0eE
Thank you so much for your continued support.
Link to article:
http://alsn.mda.org/news/genervons-master-regulator-drug-encourages-als-community
Like our Facebook page: https://www.facebook.com/gm604forals
We've also made the TV News:
http://www.cbs8.com/story/27946237/fight-for-als-drug-as-ice-bucket-challenge-cools
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