Advocacy for Genervon compound

[meghen]

Re: Dalhousie researchers activate muscles with light

Since we last spoke (in August I believe) I have gotten deeply involved in advocating & fundraising for pALS, and need to make sure that my next push is focused on the correct petition and the correct receiving party. It is regarding GM604/Genervon. One petition is directed at the FDA and US Senate. It's called 'Give Terminally Ill Patients Access to Life Saving Drugs' and has received close to 200,000 signatures on Change.org. Said petition is asking the FDA to apply Accelerated Approval to GM604. I've been pushing this one for a few weeks now and recently came across a new petition for the same thing, but directed at President Obama - to ask the FDA to agree to apply Accelerated Approval to GM604 & other promising drug studies in Phase 2A.

Here is my hang-up: If we get one million/billion signatures and get our President And the FDA on board, does this guarantee that Genervon would in fact release this supposed miracle drug, making it available to all pALS? According to Dr. Bedlack (from what I understand in one if his ALS Reversals videos), it's not the FDA or Congress holding up access to the drug, it is Genervon themselves.

My other hang-up: do we know of anyone who has actually taken GM604 (other than the 9 mentioned in another post from 2014 and the recently studied group of rugby players in another country)? Has anyone on here tried it or seen/heard of someone who's tried it w/ promising results? I'm starting to wonder if what we and many others are pushing for is A: directed at the wrong parties and B: based on any factual evidence that GM604 could in fact be the answer.

Any thoughts would be greatly appreciated, as my only intent is to help in any way possible. In the meantime, here is the most recent petition to President Obama... regardless of my questions, I see no repercussions in signing away.

https://petitions.whitehouse.gov/pe...ugh-existing-fda-accelerated-approval-program

All my love to everyone on here!

 

[lgelb]

This has been discussed extensively. I am not aware of any further data releases or FDA filings by Genervon since our last thread, and cannot imagine given the incoherence of its communication and strategy how it could prove out/bring this compound to market. I've never before seen investigators publicly at odds with the mfr in Phase IIa. If the company succeeds in selling off the program, it might materialize one day.

In short, I'd spend political capital on a more promising and potentially productive (for patients, not advocates/pundits/reporters) R&D program. There are several to choose from, as well as much basic science still to be done.

 

[meghen]

Thank you, Laurie!

Can you help me understand how I may be of help to a Research & Development group as a non-pALS?

I'm trying to figure out how I could most help anyone/everyone affected by ALS, as I've decided to turn my Fear of having ALS - into Fighting for others with ALS - in any way possible.

The furthest I've gotten thus far is the daunting realization that Riluzole was the last FDA approved medication to 'treat' ALS and that was in 1962(?). Hence the reason I've been following GM604 access, as well as looked into homeopathic and alternative ways to deal with symptoms. All the while, relaying any newly learned information back and forth and as far as anyone will listen

Honestly, any advice you may have for how and/or where to focus my energy in order to somehow make this world a better place for persons with ALS - would be immensely appreciated. Thanks again for your response and for everything you do!

 

[lgelb]

Riluzole (branded as Rilutek) was approved in 1995. The generic became available in 2013.

We do not fund-raise in these forums, but there are several ALS research initiatives affiliated with major academic medical centers, for example.

Additionally, volunteering help at any facility or agency serving the mobility-impaired, donating medical equipment/supplies, gifts-in-kind and of course cash donations are always of value. PALS in need are also helped directly by the ALS Guardian Angels.

Best,
Laurie

 

[meghen]

Thank you!

 

[Nikki J]

Stu disbanded Guardian Angels unfortunately I have not heard it was restored?

 

[lgelb]

Sorry, I mistakenly thought it might have come back to life. It hasn't.

However, in the ALSGA spirit, Meghen and all, if you have resources of any kind to spare, please pass them along to the agency serving PALS or the P/CALS in your life.

 

[Ed340hp]

Re: Dalhousie researchers activate muscles with light

Since we last spoke (in August I believe) I have gotten deeply involved in advocating & fundraising for pALS, and need to make sure that my next push is focused on the correct petition and the correct receiving party. It is regarding GM604/Genervon. One petition is directed at the FDA and US Senate. It's called 'Give Terminally Ill Patients Access to Life Saving Drugs' and has received close to 200,000 signatures on Change.org. Said petition is asking the FDA to apply Accelerated Approval to GM604. I've been pushing this one for a few weeks now and recently came across a new petition for the same thing, but directed at President Obama - to ask the FDA to agree to apply Accelerated Approval to GM604 & other promising drug studies in Phase 2A.

Here is my hang-up: If we get one million/billion signatures and get our President And the FDA on board, does this guarantee that Genervon would in fact release this supposed miracle drug, making it available to all pALS? According to Dr. Bedlack (from what I understand in one if his ALS Reversals videos), it's not the FDA or Congress holding up access to the drug, it is Genervon themselves.

My other hang-up: do we know of anyone who has actually taken GM604 (other than the 9 mentioned in another post from 2014 and the recently studied group of rugby players in another country)? Has anyone on here tried it or seen/heard of someone who's tried it w/ promising results? I'm starting to wonder if what we and many others are pushing for is A: directed at the wrong parties and B: based on any factual evidence that GM604 could in fact be the answer.

Any thoughts would be greatly appreciated, as my only intent is to help in any way possible. In the meantime, here is the most recent petition to President Obama... regardless of my questions, I see no repercussions in signing away.

https://petitions.whitehouse.gov/pe...ugh-existing-fda-accelerated-approval-program

All my love to everyone on here!

One thing to keep in mind is Genervon themselves has no manufacturing capabilities like Merck and other name pharmaceuticals. They have to have their peptides manufactured for them. They do not have the capabilities to produce GM604 in quantity on their own (neither the capital, nor the infrastructure) .

What you hear as resistance from Genervon may be a lack of product. They cannot distribute or sell what they do not have (although that may change soon).

 

[meghen]

Thank you all so much for your input!

Ed340hp - I think you are right and I feel like a cure (at least effective treatment) is right around the corner! As one of my newly made friends on FB says- 'stay strong, a cure is near.' :smile:

 

[hjlindley]

Genervon has not applied to the FDA and they have no manufacturing capacity. I don't consider them a real pharmaceutical company. I'm afraid they are stretching the truth and giving us all false hope.