Peter Gorman, University of Maryland

Sorry, I missed some information trying to solve a computer issue. Peter is talking about the need to publish every result, positive or negative.

Specifically, the HP184 Phase IIb Proof of concept study was not published because it did not meet the primary goal of improving the ASIA score.

(So, in the light of what Dr. McKay said, should we understand that perhaps if there had been a better, more precise, scale of measurement the outcome might have been positive?)

Another example . . . the ProChord Trial was stopped in Phase II abruptly (over the weekend!) in 2006 because PreNeuron was depending on money from Big Pharma -- Big Pharma pulled the plug quite suddenly and that was the end of that. Mid-study, and nobody knows exactly what they were finding out. Seems like that would be good information to have, eh?

Talking now about a couple of orphan products -- not enough market to keep these companies viable. The free market system adds a level of complexity. Could other companies be at risk? The one that makes the Lokomat, for example?

What are we supposed to do about this? How do we deal with complexity?

1. continue basic research
2. publish ALL results, even the negative ones
3. concinue to reevaluate outcome measures
4. create new outcome measures
5. expand the market; look at collateral disease states
6. continue funding from the government, foundations and industry
7. stick to good science
8. do multicenter collaboration
9. get on a regulatory fasttrack
10 focus on realistic hope

donna is introducing panel that will include a man from Acorda, who I hope will explain where time-release 4AP is!