Robert, I see you have the smoke. Got the gun too? Make a case for a broken system, I'll go along with that. Not sure the committee report is sufficiently damning to allege corruption. As for the company, Acorda could not have paid attention to the ch'ase patent two or three years ago. They were more worried about the light bill. Now, they can maximize shareholder interests by investing in R&D, etc. Let's not make this an issue of faith. It's science and commerce. Data and dollars. Let's see what they do with the opportunity.

Robert, thanks. I read the report. The was a lot of discussion about safety and about placebo and whether or not Ampyra was clinically relevant in three trials of hundreds of patients with MS. You are correct, the drug's effect was not huge compared to placebo but .... the committee report says "substantial evidence of effectiveness has been provided" and the vote was 12 to 1 in favor of granting Acorda a New Drug Application (NDA). Convincingly enough for that committee, and for the FDA.

The point of this discussion is to note the promise of ch'ase. Acorda, because of Ampyra, now has the manpower and resources to pursue its patent license for the enzyme.

Robert: 1. Watch the quote marks. Andy Blight didn't make the comment that ch'ase is sometimes injected in animal models or that there is concern about needles. I did. 2. Yes, I believe Wise Young is using an injection to deliver the cord blood cells. I'm sure his group very careful to avoid bleeding, which is one of the big issues when you poke a needle through the protective membranes of the cord into the nerve tissue itself. 3. Yes, Ampyra is dangerous in excess; there are warnings galore. 4. Ampyra was approved for walking speed in multiple sclerosis. 5. The data in clinical trials was stronger than placebo, convincingly enough.

In the original SCI trial, testing Ampyra (then called fampridine) for spasticity, the placebo group did screw up the results. 6. I have followed Acorda since it started almost 20 years ago and I see no reason to mistrust the Ampyra story, and certainly no reason to doubt Andy Blight.

As for the second set of comments, Ampyra is not cheap but much less expensive than the ABC drugs for MS. There might be physicians prescribing the drug 'off label' for SCI -- it won't work for everyone but I know people who take it and benefit. It is for sure a waste of money if it doesn't work. How it got approved ... more or less by the biotech book: They raised the money and got the data, they brought it to the regulatory folks, FDA said OK. Do I detect a subtext in your comments -- that drug companies are more likely to invest in products with long prescribing lifetimes (like Lipitor) vs. single treatments (presumably like ch'ase might be)? That's a business vs. altruism discussion for another blog. For now, let's keep an eye on ch'ase and hope thing move along forthwith.