what's the risk? ...... it works!, page-9

Dakook

I do not have the medical expertise so I cannot articulate anything about the trial process. However I do know that after that we have to get FDA approval.

Recent issues with Pharmaxis show that trial results are not everything- its also about how the data is presented to the FDA or other regulatory bodies. They came a gutser when they did not clarify why their drug was not as effective in teenagers.

PRR have hired 2 important people;

1 person who worked for the FDA and is familiar with how they need the data presented and what the FDA are looking for.

They also hired a person (think G Raymond) who was responsible at Pfizer for 20 FDA submissions.

These 2 people also give me comfort that PRR have addressed every issue that is critical along the time line.

I'm in this up to my neck and sleeping very well at night.

good luck to all.


Ramses