Genervon - GM6 - An opportunity to communicate with the FDA

[lotusturk]

There is still no decision about this drug? Why dont they allow it?

 

[frankb]

Surprised that gn6 hasn't been marketed in other countries - those countries with less stringent standards than our fda ?

 

[jennyinfrance]

Excellent! I have a twitter account @jennyinfrance and am trying to spread the word on GM604 throughout Europe.

 

[rknt50a]

ALS Rally for Faster Drug Approval (Washington, DC) - Meetup

 

[Janie H]

My sister asked if I was ready to go to Washington, I'm really not sure if I can handle a six hour drive, I am on so many medications, I have lost 30 pounds, (good thing I gained 20 when first diagnosed) I told her that I would go if she wanted to, I have clinic on Friday, this may be a busy week!

Janie

 

[MaxEidswick]

>I have bulbar onset ALS and don't have much time. I have been reading the posts on the ALSA FB page regarding GM6 and the overwhelming response is that PALS are willing to take the risk. What other options are there - death! I don't have the time to wait around for more trials.

Ditto that!

 

[Janie H]

I'm going to Washington, may be my last road trip. I need to do this.

Janie

 

[affected]

Good for you Janie!

Is your sister taking you? Will you have lots of support to make the trip as comfortable for you as possible?

 

[Janie H]

Yes Tillie,
My sister and my son/caregiver are going, I've never been to Washington (bucket list) don't know what to expect. Pray that everything will be good for us.

Janie

 

[Jeanau]

I'll pray for you Janie. You can share with all of us when you get back!

 

[Lilacs53]

Praying for a safe trip for who all are going & a thank you for doing this for us all.

 

[affected]

I'm so pleased you will have 2 people with you. Rest any way you can when you can and remember EXTRA calories as you will be burning more than usual.

Great way to do a bucket list item!

 

[rknt50a]

Thanks to all who are making the trek. This is about much more than GM604 imo. It's about PALS being heard. and respected It's about PALS being allowed access to investigational drugs in a way that will advance the science.

Two years ago at the big FDA hearing we heard PALS after PALS ask to be able to assume more risk in order to speed up drug investigations and approval. Nothing tangible came of that hearing. PALS die. The process plods along too slowly.

I hope something tangible comes from tomorrow. Surely the FDA and Genervon AND PALS can come up with a solution that gives PALS access and advances the science. GM604 may work. It very well may not. Without accelerated approval, we may never find out.

Thanks, all. Have safe travels. We're praying for a good, productive day for all.

 

[MaxEidswick]

>Thanks to all who are making the trek.

Ditto that!

 

[emi82]

#fdahope4als