Ann: Half Yearly Report and Accounts, page-29

Yes it did put a big hole in the balance sheet, and wasn't properly explained until the half yearly.

What it means and should have been properly explained at the time:

• It's not a sunk cost rather it arms them with the required data to get the FDA to agree to our preferred dosage of 2mg/kg * 2. This dosage in Stage 2 should have a materially bigger effect size and statistical significance on the primary end points than a lower minimum dose.
• This recommended dosage can go on the label once 002 Stage 2 is shown to be consistent with 2b, SAS, 008, NRL.
• We've shown we've been willing to comply with the FDA ever step of the way and we're more likely to now garnered their support and commitment in bringing this "blockbuster" to market.

In summary, we're NOT in as BAD a position as most of us have imagined of late which is equivalent to the smell of a septic tank. Confirmation on dosage for Stage 2 will be a MASSIVE catalyst as 39KP has nicely set out Post #: 72698395