t315i mutation testing , page-4

The FDA can be real obstructionist. Have a look at what they did to another Australian Company, Pharmasix, late last year:

First the FDA Advisory Committe recommenda approval on 26/11/09: http://www.hotcopper.com.au/asx_announcements.asp?id=115850

Then the FDA disapprove on 29/12/09: http://www.hotcopper.com.au/asx_announcements.asp?id=135361


My personal interpretation of the FDA request from CXS is that they come up with a validated test that identifies the test patients that have (or had) the T31521 mutation. Then they have to correlate this with the clinical test results CXS already establlished. I don't believe any further testing or retesting is required. Sounds simple but CXS will have to get this 101% right to satisfy the FDA.

It will probably take a few months. Investors (or speculators) have become very impatient and don't fully understand the FDA's request. A few reassuring bulletins from CXA management would stabilise the share price, but it's clear to me that communication is not their forte.