Genervon - GM6 - An opportunity to communicate with the FDA

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I have to say here that if you have ALS/MND or know someone/are a CAL you MUST speak to the FDA today! Right now! Anyone can be an advocate! If you have any use of any limb, finger, arm, leg, toe this is your/our/everyone's chance to plead. I'm very lucky to have a strong working left arm/hand and know that many here are almost left with nothing. If it takes all of your energy from the day to write the FDA today do it! One difficult character at a time! Everyone is in this together and is fighting the fight behind the computer or from a chair or bed.

Let us rise together and make some noise today!

I have a little over 3k followers on my twitter and am blasting each one with a personal DM to write the FDA. It's not much but it's the very best I can do.
 
Sorry for a double post:

From reading up from several sources about the FDA and their attitude about ALS, it seems as though they are not well educated on the disease and in a few places i'm seeing an almost total ignorance of the implications of this disease.

Your stories, your daily struggles need to be communicated to them. They need a new perspective on the dark existence that is ALS. They let medications with much more risk slip by while simultaneously putting acting harshly on much more important meds for terminal illnesses. Most want to say that that they are 'evil' for doing so. I'm willing to say that they are just grossly uneducated and their approval process perpetuates their ignorance.

Your voice can disrupt this vicious cycle. I just had to include this last bit. Sorry for the double post.

CP
 
If anyone has cordial relationships with ALSA, MDA, ALSTDI, ALS Hope, Les Turner, NEALS, etc., please ask them for a position statement on Genervon FDA request.

I think that it would be helpful if organizations would make statements. If they are supportive, fine. If they are not supportive, fine. I just think that they need to say something enlightening on a matter of urgent interest to the people they are paid to help.

Thanks.
 
Hi all,

Hopefully there will be some positive news to come from this. If hyperphetically this treatment gets fast tracked what does this mean for those based in the UK?

Is there anything we can do from the UK to help fast track this treatment?

Take Care x
 
There was some discussion on this on MNDA forum. You might want to look there. What the FDA does or not do does not of course directly affect you in the UK but if it goes forward at least they will be manufacturing it so there would be something for you to lobby your decision makers about. If the FDA turns it down then it would be a harder road
 
Dear All,

Thank you for writing to Genervon about your interest in GM6. Attached are our two latest press release of our trials results. Sorry there is no giddy up option to Tijuana clinic or several variation of it as suggested by a few of you.

Genervon is meeting FDA next month for accelerated approval of GM6 for all ALS patients. Our plea is that ALS patients cannot wait and GM6 is very safe with no significant adverse events in any treatment group patients, plus incidentally GM6 is efficacious including Genervon trial programs for other neurodegenerative diseases. Genervon argued that 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
5. Demonstrated ability to regulate homeostasis

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. Although Genervon acknowledges the paramount importance of public safety in the FDA’s drug approval process, it also believes that ALS presents a compelling case for an exception to the usual process. This view is of course shared by many sufferers of ALS.

However, the chance of a quick approval by FDA is very small. FDA has the mandate and mindset to know as much as possible about the disease and the new drug no matter how long it would take. But all of you being an important constituent FDA will listen to your voice if you choose to express it. Your expression should be appropriate and appreciative. You can also express your support through social media, ALS non-profit associations or other channels.

A sample of a patient's voice:
"It is horrifying to be told that you will die very quickly and along the way be reduced from a vibrant adult to less than an infantile state, all while retaining your cognition but losing the ability to express it. I live this way every day. Every waking moment is a fierce battle between iron determination and utter despair. For the first time in history we have a treatment with major effect and an excellent safety profile. PALS need treatment options RIGHT NOW. The risk of GM6 at this point is extremely acceptable to us, especially given that without treatment the risk is 100% fatal. We cannot wait another few more years while tens of thousands of us die. Please 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."
 
I just finished writing to FDA. Who knows, maybe it will make a difference.
 
GM6 drug petition

PLEASE everyone go Google the petition for the gm604 drug by genervon. I would post the link on here but don't know how. the company is meeting with the fda in February to try and get approved to have the drug made available now so we don't have to wait 7 years for phase 3 to be completed. listen I know ALS sucks Ihhave it to but we can't just sit around bashing everything that might help like people tend to do on this site. this is our chance to have a voice and get this drug made available NOW. PLEASE Google gm604 petition and sign it
 
What is the link to CDER that is supposed to be the best source to send the petition to ? Other than that anyone know the official FDA website?
 
Music the OP gave the link :)

goo gle is a good place if you aren't sure of where something is too
 
>I just finished writing to FDA. Who knows, maybe it will make a difference.

In'Shallah!
 
I signed the petition, wrote the FDA as well as my congressman and both senators.
 
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