Dung,you clearly have no experience in the conduct of such...

Dung,

you clearly have no experience in the conduct of such trials? Which is fine, but i just feel the need to correct your misconceptions.

To meet the stringent requirements for approval to conduct a pivotal trial (let alone get a NDA) do you really think the FDA leave that up to the integrity and discretion of the CRO? Seriously? I mean CROs could be manipulating results left right and centre to get their drug approved.

Let me put your mind at rest.

1. For the ethics committee to even allow the trial to enrol patients, firstly an independant Principal Investigator must be selected. This is the person responsible for assessing the trial data. They stand at arms length to the company.
2. All data collected from every nurse, from every interview is included in the data package submitted to the FDA. Everything is checked for consistency. There is no room for manipulation of results.
3. The FDA work through all the data, the interpretation in determining whether to approve a pivotal trial which will then be run in the US through a different hospital.

The speculation you try and lead us to is just unfounded. What is your interest in trying to discredit IRX?

All the best in your investments but i think you will miss a good one here.

Disclosure : have already lodged votes for EGM and voted in favour of all resolutions.

Bring on 17 Feb EGM so we can really get started here!