Pivotal Trial

Nice lift in the SP after the trading halt was lifted, but not as much as one might have expected.

It is clear that 0084 crosses the BBB and has a beneficial effect, so I wonder whether some investors are considering the time it will take to start a registration trial; and what such a trial will involve. Perhaps those in contact with James will be able to answer those questions?

My guess is that the FDA will require a signed study report for both parts of the current trial before it would approve commencement of a pivotal trial. It is ironic that the better the result, the longer it takes for a trial to complete, so it might be some time before we reach that position.

This should not alarm shareholders, providing they take a medium-term view. If the drug achieves FDA approval, it will not matter how long it takes.