RespireRx Pharmaceuticals Inc (fka RSPI)

[neuroinv]

It's not the absolute number of patients, it's the (apparent) clarity of the trend. If they have (to make up numbers) eight patients who show a 60% decrease in apnea frequency, whereas the two placebo patients show no change (there is some question as to whether there is a placebo effect in apnea trials)--that's going to be sufficient. But if there is a fair amount of variability amongst the patients, then it becomes ambiguous, and quickly.

I had an interesting conversation a couple weeks ago with a BP for whom I am providing some licensing consultation (unfortunately, there is virtually no overlap between their interests and Cortex's available assets) about what constitutes POC--proof of concept. The fact is that no Phase IIa study really 'proves' a concept, it may take PhIIb or even PhIII to really 'prove' it (the latter, in the case of the FDA). So I suggested the term HOC--'Hint of Concept.' You don't need p=.05 for HOC.

Deals are being made where the initial upfront is not as large as it would be with a more robust PhII dataset, but if a larger PhII trial confirms HOC/POC. a second milestone is paid which makes the small company 'whole.' That could be another avenue for a SA deal.

NeuroInvestment