It's Time To Think Out Loud

When I testified to a very stoic FDA panel at the ALS hearing two years ago, I envisioned thought-clouds above a lot of heads.  When people with ALS, their caregivers, drug developers, and organizations asked for faster approvals, I imagined FDA scientists facing us thinking, "Fine. Bring us something."

There was a lot that was unspoken in that room.

It's time to speak.  It's time to get a proposal on the table and work out the good, the bad, the ugly, the impossible, and, yes, the possible.  There is a willing drug developer.  There are people with ALS who are more than willing to accept risk beyond a normal clinical trial in order to advance the science and have a chance at a possible therapy.  There is an FDA that understands the urgency of ALS within the context of its serious responsibilities.

Let's think out loud this time, candidly.

The Genervon GM6 conversation has its roots (literally grassroots) on the forum at www.als.net .  To view the forum requires registration, but it is well worth it if you are interested in the science and challenges.

In addition here are some pertinent background links --

- This blog's first post on the subject including a letter from Genervon.
- This blog's second post on the subject about choices.
- The change.org petition started by a gentleman with ALS with 19K signatures as of this morning.
- An important blog from another gentleman with ALS who has taken GM6 and is working with Genervon.

Silence is easy.  It's time for some difficult conversations.  Out loud.