Genervon - GM6 - An opportunity to communicate with the FDA

[Music67]

The Genervon people claim to have either halted or stopped progression in 7 out of 8 people in the testing and had even one or two of them have improved conditions. Now if they are making this up it seems to me that this would cause them to lose credibility before the FDA and only hurt their chances of having a real treatment okayed in the future.

 

[Nikki J]

I do not think they are flat out lying by any means. I do think they are sharing data very selectively and we all know that data can be manipulated quite a bit. They have not shared the full results just bits and pieces in a news release. They offer no statistics to back up that slowed or stopped statement based on which measurements? Breathing declined overall slightly. They do not share the alsfrs data but we know that can be imprecise and mine has certainly been stable for 12 weeks at a time without GM 604
I do find hope in this and I did sign the petition but even if there is no exaggeration here remember only 8 PALS in the trial plus Eric received this. A total of 13 people. If we took 13 of us and followed us in 2 groups over 12 weeks by chance we might find what looks like a difference attributable to whatever we decided as an intervention ( wearing blue every day as a frivolous example) but was just chance. Time will tell for this. I hope we all get a chance to find out the answer

 

[affected]

They offer no statistics to back up that slowed or stopped statement based on which measurements? Breathing declined overall slightly.

That concerns me the most.

 

[Lilacs53]

I received the following email from the young man who started the petition, as probably you all have. It has me a little concerned in that why start a new one, when it's hard enough to get people to sign it to begin with? I have gotten a total of four people to sign it (the previous one) and am finding it rather difficult to get others to. Some think that online petitions don't do any good, some are leery of having to giving their addresses and who knows what the reasons could be. I understand he wants it to be as professional as possible, but I honestly thought the previous petition was professional enough. Here's his email in case some of y'all haven't seen it yet.

"It Looks Different But It's Still The Same Petition
Nicholas Grillo
San Francisco, CA

Jan 16, 2015 — Hi Supporters:

I case your wondering, I was offered (and accepted) professional help with our petition asking the FDA for preliminary approval of GM6. I was also offered help with social media, general awareness, reaching celebrity supporters, and how to contact legislative representatives. So if your questioning why the petition looks different and reads differently, now you know why.

I hope your as happy as I am to be getting all this help.

Also, if your wondering why the signature goal keeps rising, it's changing as the rate of signatures per hour keeps going up. See, I just want to get as many signatures as possible by the deadline (February 01, 2015). I don't really care about reaching any "goal".

So not to worry, It's still me, Nick, asking for the same thing, preliminary approval of GM6 by the FDA.

Did you email a senator today?

Thanks,
Nick
[email protected]"

 

[Lilacs53]

That concerns me the most.

Tillie

It concerns me too.

 

[Nikki J]

I understood what Nick said as meaning it was reworded slightly I think the signatures carried over from the first draft? Maybe slightly odd as names go on a petition that is different than what was signed but the meaning and request were not changed as far as I can see and he has been very upfront in saying what was done.

 

[dhuntley]

Yes, the signatures carried over. And the petition request remains the same - that the FDA grant conditional approval to GM6. the petition originator simply edited the rationale, making it more about how the disease affects people and less about the science of GM6.

 

[dhuntley]

In addition to asking people to sign the change.org petition, I think it is critical to flood the FDA with personal stories from PALS, CALS, and friends of PALS and CALS urging them to grant conditional approval of Genervon's GM6. Make the FDA see the people suffering from ALS and face the consequences of rejecting Genervon's application. The most direct link to the form (page) used to submit comments is

Contact CDER

Below is the comment I sent them:

Quote:
It is my understanding that Genervon will be meeting with you in the next month to request conditional approval of GM6 for use with patients with ALS. I am writing to urge you, to plead with you, to grant that request. I was diagnosed with ALS in July of 2013. Three months prior to my diagnosis I completed an Ironman Triathlon and was a Distinguished Lecturer for the Groundwater Resources Association of California. In the 1 ½ years since I was diagnosed with ALS I have lost the ability to run, walk, stand, speak intelligibly, and eat solid foods. I have lost half of my breathing capacity. Without access to GM604 I will pass in the next 6 to 12 months. I am not alone. Given the rate of occurrence of ALS and the median post-diagnosis longevity, 10,000 or more of us will die during the time it would take Genervon to complete a traditional phase 3 trial.

Please don’t get me wrong. I understand that the very promising results from the phase 2 trial are from a small population (N=9), and may not be seen in the larger ALS population. But GM6 is not a drug for acne, weight loss, high cholesterol, or even cancer, where alternate drugs are already available or where the absence of a drug is non-fatal. If GM6 is effective at slowing or stopping my progression, I will have a bit more time to be with my wife, daughter, and grandson. If GM6 is not effective at slowing or stopping my progression I will die in 6 to 12 months. But if Genervon is not granted conditional approval of GM6, there is a 100% chance that I will pass in the same 6 to 12 months. Please do not condemn me, and 10, 000 others like me, to death. Grant conditional approval of GM6 and let those of us with ALS be, in effect, participants in a large trial of GM6.

 

[dhuntley]

Also, contact your senators and congressional reps!

 

[Graybeard]

Very persuasive, DH. My DIL is running this for me.

 

[Marv]

I am a Canadian ALS victim reading as much as possible on Genervon and GM 604.
Questions; Why would the system allow Genervon to give false hope? Facts are facts.
Why would the ALS Assosiation not be involved with this drug? They should be the voice of ALS all across USA and to FDA. A world without ALS.

Why would this not fall under Expanded Access program of the FDA?

I am told that Genervon is just a small Co. that could not afford phase 3 and if does not get patnership will phase out. Why is the system money based and not medically based?
Rilutek since 1996, how long does it take to turn donations of hope into RESULTS?
I do hope Genervon is allowed to prove its self and is not just pushed out.

 

[Lilacs53]

My Dr gave me a website where I can check on trails that are going on and ones that have completed, I did find a study on GM6 there. Here is the website page that has the study listed for those who don't have it already. https://www.clinicaltrials.gov/ct2/results?term=GM6&Search=Search

Thank you everyone for making the clarification on the petition...I have less of a problem with it now. I think Marv raised some good questions, which I don't have an answer to.

 

[Nikki J]

One thing about the clinical trials page is that is not updated regularly. I am not sure whose responsibility it is probably those running the trials are supposed to notify the site when status changes. The last update on the gm604 was 4/14. The trial is done and it is the news release from that trial that started all of this.
I have noticed this before with other trials I know are fully enrolled or finished it will say recruiting. Clinical trials page is a good place to start looking though

 

[Music67]

Good morning and a word of explanation - This new avatar of mine shows myself with my fiance Camille. Plan A is for us to marry next month. We've been engaged for exactly a year.

 

[Graybeard]

Congratulations!