I really don't agree with this notion that a study with only 12...

I really don't agree with this notion that a study with only 12 participants will never be of much value because the sample size is too small. Statistical analysis is about more than just sample size. One needs to take into account the standard deviation of the population data and the extent to which the results from our sample deviate from the population mean.

The statistic that matters is the less than 1 in 1,000 chance of all participants surviving the trial on a placebo.

It's a pretty compelling statistic. Hard to see how the FDA would not consider that enough to justify the designation.

With respect to funding, I think the new board would be silly to make any decisions prior to hearing back on the ODD application - especially given how soon it is expected.

If the board could announce the successful ODD designation and at the same time give a positive update on the progress of patients on the extension trial, we'd be in a very good position to get all the funds we need on quite reasonable terms.