The Great Pharmaust FDA ODD Approval Sweepstake, page-145

Totally agree and it's as frustrating as hell. Literally life and death for these poor patients and nothing on the doctors prescription pad that gives them any real hope. Many of the MND patients being treated today will be dead by the time the FDA makes a decision on whether MPL will be a approved or not.

In NZ we went through years of fighting the powers that be to allow the "right to die" law to be put on the books. I can't help seeing the irony that some decision makers want to stop people ending their life in cases of terminal illness, and others will take as long as legally allowed when making decisions which could save the same life. I know that there have to be rules and safeguards, but come on! As far as I know the ODD is not giving PAA the right to sell MPL to anyone, it's just helping it along the way to being fast-tracked IF IT WORKS. No risk here.

I think the ALS community has a strong lobby group in the States. Let's hope that they are doing their thing and that common sense prevails with getting things moving ASAP not just according to the standard timelines.